... Product: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine; KINRIX FDA STN: 125260 ...
Center for Biologics Evaluation and Research (CBER)
... Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine. -. Product. Kinrix. -. Contact Us. Consumer Affairs Branch ( ...
... US. -. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed. -. Products. Adacel Sanofi Pasteur, Ltd. ...
... Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined ...
Page 1. Post-Approval Adverse Event Review: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated ...
... 1090, to import Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), "Infanrix," for the primary and booster immunization of infants ...
... Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP; Tripedia®), and used according to the Indications and Usage section of the FDA ...
... previously reviewed by myself and others in BLA supplements submitted by Novartis. ... Turbid liqUid a'ter shaking White deposit and colourless supernatant allel ...
... febrile seizures, brachial neuritis, arthritis, anaphylaxis, erythema ... other vaccines has not been studied with the ... ofpotential safety risks, a study shows that ...
Page 1. Post-Approval Adverse Event Review: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX� ...
toxoid and 5.0 Lf of tetanus toxoid. The combined components are adsorbed using aluminum potassium sulfate and preserved with 1:10,000 thimerosal (Table_1)....
Science.gov Websites
CDC Guidelines September 26, 2003, Vol 52, #38 Notice to Readers: FDA Approval of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, (INFANRIX®) for Fifth...
... GlaxoSmithKline Biologicals Attention: Ms. Donna Boyce 2301 Renaissance Boulevard . PO Box 61540 .. King of Prussia, PA 19406-2772 Dear Ms. Boyce: ...
The introduction of acellular pertussis (Pa) vaccines in countries with a low uptake of whole-cell pertussis (Pw) vaccines has led to a dramatic reduction in pertussis disease. Diphtheria-tetanus-acellular pertussis (DTPa) vaccines have also ensured continued high level ...
PubMed
An important step in vaccine production and quality control is the analysis of identity of different lots. For that purpose chicken was immunized with acellular Pertussis components (Pertussis toxoid, Filamenteous haemagglutinin, Pertactin, Fimbriae 2/3 antigen). The resulting antibodies (IgY) were non-invasive extracted from egg yolk ...
On June 20, 2008 the Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV), and Haemophilus influenzae type b conjugate (tetanus toxoid [TT] conjugate) vaccine, DTaP-IPV/Hib (Pentacel, Sanofi Pasteur, Swiftwater, Pennsylvania), ...
Using 2 real-time polymerase chain reaction (PCR) assays for Bordetella pertussis, 2 of 5 acellular pertussis vaccines were found to contain B. pertussis DNA. Because residual DNA in vaccines can cause environmental contamination, the administration of acellular pertussis ...
Bordetella pertussis is the causative agent of whooping cough, a major childhood pathogen; acellular vaccines consisting of purified B. pertussis antigens such as filamentous haemagglutinin (FHA) are commonly used to prevent pertussis. Despite the importance of FHA in B. pertussis pathogenesis ...
PubMed Central
... 10366 103666/5041) describing modifications to the potency assay for the (' , . 6/5036, describing modifications to the assays for all pertussis antigen~ and ...
... Sample size and statistical power calculations were based on overall age-specific pertussis rates during 2004-2006, projection of Pentacel market share ...
members offered PEP and vaccination with the newly licensed tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap) to all personnel in the hospital's...
... 15 Lf), tetanus toxoid (5 Lf) and acellular pertussis antigens (10 ?g detoxified pertussis toxin, 5 ?g filamentous hemagglutinin, 3 ?g pertactin, and 5 ?g ...
and Licensures CDC. Updated Recommendations for the Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on...
The document is the printed transcript of a workshop held to discuss the current status of research to develop and clinically test new acellular pertussis vaccines.
National Technical Information Service (NTIS)
... effects in children with weakened immune systems include diphtheria, tetanus, and acellular pertussis; hepatitis A; hepatitis B; ...
MedlinePLUS
... Immunization with diphtheria toxoid does not, however, eliminate carriage of C diphtheriae in the pharynx, nose, or on the skin. ...
... Thimerosal, aluminum and free formaldehyde content, sterility and general ... Tripediam is compounded, filled, labeled, packaged, and released by ...
Samples of pneumococcal vaccine polyvalent, 7-valent pneumococcal conjugate vaccine, and two different diphtheria and tetanus toxoids and acellular pertussis vaccines adsorbed were irradiated with X-rays and/or gamma-rays (Co-60). Mouse IgG and IgM antibody responses (ELISA) for types 9V, 14, 18C, and 19F pneumococcal polysaccharides ...
NASA Astrophysics Data System (ADS)
On June 24, 2008, the Food and Drug Administration licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine, DTaP-IPV (Kinrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Kinrix is licensed for use as the fifth dose of the DTaP vaccine series and the ...
Treatment of mice with Bordetella pertussis vaccine resulted in resistance to mouse adenovirus infection. Antiviral activity was associated with surface components of B. pertussis. Acellular fractions with antiviral activity were obtained by relatively ge...
In Canada, the fifth dose of the routine childhood immunization schedule against diphtheria, tetanus, pertussis and polio is given at 4-6 years of age. Up to 30% of children may have significant local reactions (redness, swelling) and this may be related to pertussis and diphtheria antigen content. We sought to determine if a combination product with lower ...
, vaccination with purified B. pertussis-derived pertactin, filamentous hemagglutinin or the human acellular- derived antigens in the acellular vaccine, Adacel, or the individual proteins pertactin or filamentous killed B. pertussis in 1 ml of PBS [33], 40 mg of purified pertactin 1 [34] or 5 mg of filamentous
E-print Network
The Bordetella pertussis pertussis toxin and pertactin (Prn) are protective antigens and are contained in acellular pertussis vaccines. Polymorphisms in the A subunit of pertussis toxin (PtxA) and pertactin have been proposed to mediate vaccine resistance and contribute to ...
... is given as part of the DTaP vaccine (diphtheria, tetanus, acellular pertussis). The Tdap vaccine (which is similar to DTaP but with lower concentrations of diphtheria and tetanus toxoid for adults) is given to ...
Yes, the Advisory Committee on Immunization Practices (ACIP) recommends 5 doses of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine for infants and children....
... Health officials recommend that children receive a fifth dose of the diphtheria- tetanus-acellular pertussis (DTaP) vaccines when they begin school. ...
... 19. We note that there was one case of autism within three days following the fourth dose of Pentacel (49401_addnl_safetyanalyses.pdf, page 260). ...
... Theresa Finn Karen Farizo Milan Blake Edward Wolfgang Paul ... ofPentacel relative to DAPTACEL: Sanofi said a sample ... Sanofi stated that the tpagnitude of the anti ...
... The first phase validated the ability ofa new shipping packing configuration _ _ to maintain the internal temperature ofthe package to within the target range ...
... and FHA than DAPTACEL although it should be pointed out that ... and FIM elicited by PENTACEL is as high or higher ... responses to PT, FHA and FIM was higher for PENT ...
... for Closure Integrity Testing- Correlation between and SSO 1-023- REP (Report for Closure Integrity Testing - Correlation De['wef~n _Iwere provided. ...
... The mixture of these purified and inactivated polioviruses is used for production by Sanofi Pasteur (SP) of two IPV products: IPOL® (virus grows on Monkey ...
... is manufactured at Aventis Pasteur Limited (Canada) and Haemophilus b Conjugate Vaccine (Tetanus Protein�Conjugate) Vaccine referred to as PRP�T Vaccine is ...
... supplemental � 1 � Page 2. database of non.rlhospitalizations among_members and state Mortality Tapes. General Comment(s) � Please ...
... with Diptheria, Tetanus Toxoids, and Acellular Pertussis Vaccine, Absorbed (Infanrix®) and ... of HAVRIX® (720 EL.U/0.5 mL dose) with Infanrix and ...
from the schedule, endorsed an all-inactivated poliovirus vaccine (IPV) schedule for polio vaccination, recommended exclusive use of acellular pertussis vaccines for all doses...
... administered separately versus combined in younger and older ... Disease Among Infants and Young Children. ... Toxoid-tetanus toxoid acellular pertussis vaccine as a ...
... The language in the indication providing immunization prior to the 7th birthday is intended to allow for catch up primary immunization.� ...
... with mild illness such as diarrhea, mild upper respiratory infections with ... All major equipment and analytical methodology have been appropriately validated by ...
... ii. Please provide the reactivity of PT~~~~ with the fimbriae Please present this informat on form together with reactivity data (generated in the same ...
... PT/FHA components 3. purification of PT, FHA, and PRN antigens 4. detoxification of purified PT, FHA, and PRN antigens 5. adsorption of purified ...
... post-vaccination � Adverse events that resulted in a hospital admission, life-threatening ... that represented a change in health status, daily, on Days 0 ...
... failure. 1 to 4 Months HepB 2 Months Diphtheria, tetanus and acellular pertussis� DTaP Prevents: Diphtheria, a serious bacterial infection that can lead to ...
(PDF)* � Immunization Requirements (2005-6) � Summary of Requirements � Diphtheria, Tetanus and acellular Pertussis (DTaP) � Tetanus and Diptheria (Td) Booster �...
spacer spacer APPENDIX A. Summary of Recommendations for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) Use Among Adults The following...
... efficacy studies: Sweden Trial I: the SPL aP component was evaluated and shown to be effective using the Daptacel formulation (10 J..lg pertussis toxin (PT), 5 ...
after introduction of acellular pertussis vaccines. Archives of Disease in Childhood 88, 684 the coexistence of the two pathogens, with or without vaccination. We then track the dynamics of the system following the introduction of anti-pertussis vaccination. Our results suggest that (1) in order for B
Tdap and Td vaccines See Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on...
In industrialized nations, routine use of pertussis vaccines has shifted the burden of pertussis disease from middle childhood to one primarily affecting young infants, adolescents, and adults. Although generally not as severe as observed in infants, pertussis in adolescents and adults can be serious, and these older age groups are ...
Despite sustained high coverage for childhood pertussis vaccination, pertussis remains poorly controlled in the United States. A total of 16,858 pertussis cases and 12 infant deaths were reported in 2009. Although 2005 recommendations by the Advisory Committee on Immunization Practices (ACIP) called for vaccination with tetanus toxoid, ...
... generally given at the 4-month visit: second diphtheria, tetanus, acellular pertussis (DTaP) vaccine second Haemophilus influenzae ... 6-month visit, your baby may receive: third diphtheria, tetanus, acellular pertussis (DTaP) vaccine possibly the third ...
BACKGROUND: Although decennial adult boosters of tetanus and diphtheria toxoids are recommended in Canada and the United States, a second dose of pertussis vaccine is not currently recommended for adults. METHODS: This open label, post-marketing, multicenter study evaluated the tolerability and immunogenicity of a second dose of an adult formulation of tetanus, diphtheria, and ...
Cell-mediated immune (CMI) responses to an acellular pertussis vaccine administered to 49 subjects, a subset of participants in the National Institutes of Health-funded adult acellular pertussis vaccine efficacy trial, were evaluated and compared with antibody responses to vaccine antigens. Levels of proliferation ...
Diphtheria, tetanus and pertussis vaccines have formed the cornerstone of childhood immunization programs for decades. Historically, these have comprised diphtheria and tetanus toxoids combined with inactivated whole-cell pertussis. More recently, advances have been made with the development of purified acellular ...
On June 10, 2005, a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) formulated for use in adults and adolescents was licensed in the United States for persons aged 11-64 years (ADACEL, manufactured by sanofi pasteur, Toron...
During spring 2005, two tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) products formulated for use in adolescents (and, for one product, use in adults) were licensed in the United States (BOOSTRIX, GlaxoSmithKline Biologi...
From pertussis to meningococcal disease and back represents nearly 30 years of research at Porton, first at the Centre for Applied Microbiology and Research and latterly as part of the Health Protection Agency. I joined the group lead by Andy Robinson developing an acellular pertussis vaccine and was part of an exciting period that ...
Pertussis remains a serious problem in many countries. Even in countries with high vaccine coverage and a long vaccination history, pertussis outbreaks occur periodically. Rather than being a disease of young children, pertussis has shifted to affect adolescents and adults. Increased pertussis burden in adolescents ...
At 2 months of age, 145 infants were randomized to receive either a two-component acellular pertussis vaccine [lymphocytosis-promoting factor (LPF)/filamentous hemagglutinin (FHA)] or standard whole-cell pertussis vaccine, each combined with diphtheria-tetanus toxoids, as their primary immunization series. Of the 132 subjects (91%) who ...
This open-label, randomised, controlled study examined antibody persistence following infant vaccination at 2, 3 and 4 months of age with either an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Haemophilus influenzae type b (DT(5)aP-IPV-Hib; Pediacel) or a whole-cell pertussis (DTwP//Hib+oral poliomyelitis vaccine ...
A segment of chiropractic has historically opposed the practice of immunization. This opposition has been based on historical and philosophical precedent, but with little support from the scientific literature. Pertussis immunization has successfully controlled a disease with a prior history of high childhood morbidity. An evaluation of the literature fails to find supporting ...
In a number of countries, whole cell pertussis vaccines (wcP) were replaced by acellular vaccines (aP) due to an improved reactogenicity profile. Pertussis immunization leads to specific antibody production with the help of CD4(+) T cells. In earlier studies in infants and young children, wcP vaccines selectively induced a Th1 ...
In a number of countries, whole cell pertussis vaccines (wcP) were replaced by acellular vaccines (aP) due to an improved reactogenicity profile. Pertussis immunization leads to specific antibody production with the help of CD4+ T cells. In earlier studies in infants and young children, wcP vaccines selectively ...
This study was to assess the humoral immune response induced by a vaccination schedule routinely used in France in 18-50 year old adults with unknown vaccination history. In this monocentric, prospective study, subjects received one dose of REVAXIS� (dT-IPV, diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)) (Visit 1) followed ...
To examine the influence of a pertussis booster vaccination on the transfer of maternal antibodies, 24 nonpregnant women received a tetanus, diphtheria, acellular pertussis booster vaccine between 2 consecutive pregnancies. Blood was drawn from mothers and off-spring. Efficient transplacental antibody transfer and significantly higher ...
In Finland, the whole-cell pertussis vaccine was replaced with acellular pertussis vaccine in the national immunisation schedule in 2005. Adolescent booster vaccinations were also included in the programme. The aim of this study was to evaluate the effects of these changes on the epidemiology and strain characteristics of Bordetella ...
The results of phase 3 efficacy trials have shown that acellular and whole-cell pertussis vaccines can confer protection against whooping cough. However, despite the advances in vaccine development, clinical trials have not provided significant new information on the mechanism of protective immunity against Bordetella pertussis. ...
The main objective of this study was to assess in 5-6-year-old French children (n=234) the persistence of antibodies induced by a primary series vaccination (at 2-4 months of age) and a first booster (at 12-16 months of age) with a pentavalent two-component acellular pertussis combined vaccine (DTacP-IPV-Hib; Pentavac). The second objective was to evaluate ...
2000 CHAIRMAN John F. Modlin, M.D. Professor of Pediatrics and Medicine Dartmouth Medical School Lebanon, New Hampshire EXECUTIVE SECRETARY Dixie E. Snider, Jr., M.D.,...
... to DTaP or DTaP-IPV ( 11,12 ). All subjects had seroprotective antibody ... vaccines, with similar effects on cell-mediated immune responses 3.5 years ...
declines vaccine. Varicella History: If no confirmed disease history, serological test is required and recorded medical history for all personnel and members of the medical staff. The examination shall (CDC): � Proof of immunity against mumps � Recommend Td with Acellular Pertussis vaccine (Tdap
against meningococcal disease for persons aged 2--18 years (6). The tetanus and diphtheria toxoids/tetanus and diphtheria toxoids and acellular pertussis vaccine (Td/Tdap)...
upon the child's history of monovalent 2009 H1N1 vaccination (4). Use of tetanus and diphtheria toxoids, and acellular pertussis (Tdap) vaccine among children aged 7 through 10...
Prophylaxis Against Diphtheria (D), Tetanus (T), Acellular Pertussis (aP), Hepatitis B (HBV) and Poliovirus Types 1, 2 & 3 (IPV)
ClinicalTrials.gov
... FDAlCBER participants: Theresa Finn Edward Wolfgang Bob Ball Soju ... CBER said they would fax sanofi an outline of the ... Dr. Decker stated that the BLA data do not ...
... Table 2: Evaluation of responses following immunization with four doses ofPent ace 1 compared to responses following four doses of t 1 .. . tId· 494 01 d P3T06 ...
... TRANSMISSION OK TX/RX NO DESTINATION DESTINA TION ST, TIME TIME USE PAGES SENT RESULT TEL ID # 2572 814166672812 05/16 16:01 00'38 4 OK , " " , ...
in infants born to hepatitis B surface antigen (HBsAg)-negative mothers, the use of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP), and the use of...
receive the following vaccines: meningococcal conjugate (MenACWY, 1 dose); tetanus, diphtheria, acellular pertussis (Tdap, 1 dose); and (for females) human papillomavirus (HPV, 3...
... 4.0 Description of Clinical Data Sources This supplement contains clinical data from two studies conducted in Germany (Studies APV-118 and APV-120) and one US ...
visit this page: About CDC.gov. Vaccine Safety Vaccine Safety Vaccines Safety Basics Diphtheria, Tetanus, and Acellular Pertussis (DTaP) Haemophilus Influenzae Type B (Hib) Hib...
Strains of B. pertussis isolated from patients in Moscow in 2001-2005 as well as strains included in locally produced diphtheria-tetanus-whole cell pertussis (DTP) vaccine were studied. Nucleotide sequences in genes of pertactin and S1-subunit of pertussis toxin of isolated strains, their immunobiological properties and opportunity to ...
Pertussis is an infectious disease of the respiratory tract in humans caused by Bordetella pertussis. Despite extensive vaccinations, pertussis has remained endemic and re-emerged. In Finland, a whole-cell pertussis vaccine has been used since 1952 with high coverage. In Sweden, whole-cell vaccinations were ...
The number of pertussis cases in Japan has decreased dramatically following the nationwide use of an acellular pertussis vaccine combined with diphtheria-tetanus toxoids (DTaP vaccines) which began in 1981. However, the effectiveness of the DTaP vaccine has not been systematically evaluated using appropriate epidemiological methods ...
The distribution of IgG-subclasses provides insight in the immunological mechanisms of protection against whooping cough. We investigated the effect of Dutch whole-cell pertussis and acellular pertussis vaccines administered in infancy on the IgG-subclass distributions in healthy children aged 12 months, 4 years and 9 years as well as ...
The measurement of IgG anti-pertussis toxin (IgG anti-PT) antibodies by ELISA is a frequently used method for studying the antibody responses after pertussis vaccination and after Bordetella pertussis infection. Such responses vary according to the different vaccines used as well as to the immunization and infection history of the ...
This study examined the vaccine potential of the autotransporter protein BrkA of Bordetella pertussis in the sublethal intranasal murine respiratory challenge model of infection. Five different acellular pertussis (Pa) vaccines, containing different pertussis-component antigens but all comprizing diphtheria (D) and ...
Pertussis, an acute respiratory infection caused by Bordetella pertussis, classically manifests as a protracted cough illness. The incidence of pertussis in the United States has been increasing in recent years. Immunity wanes after childhood vaccination, leaving adolescents and adults susceptible to infection. The transmission of ...
In 2005, two tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines were licensed and recommended for use in adults and adolescents in the United States: ADACEL (sanofi pasteur, Swiftwater, Pennsylvania), which is licensed for ...
The main objective of this study was to assess in 5-6-year-old French children (n=162) the persistence of antibodies induced by a primary series vaccination (at 2-4 months of age) with a pentavalent whole-cell pertussis combined vaccine (DTwcP-IPV-Hib; Pentacoq) and a first booster (at 12-16 months of age) with a pentavalent two-component acellular ...
Multilocus variable-number tandem-repeat analysis (MLVA) of 316 Bordetella pertussis isolates collected over 40 years from Australia and 3 other continents identified 66 MLVA types (MTs), including 6 predominant MTs. Typing of genes encoding acellular vaccine antigens showed changes that may be vaccine driven in 2 MTs prevalent in Australia.
Bordetella pertussis isolates not expressing Pertussis Toxin (PT) or Pertactin (PRN) have been collected, for the first time in 2007, in France, a highly vaccinated country with acellular vaccines. Non-expression was due to deletion of the entire ptx locus, to IS481 insertion in the prn gene or deletion of a part of this gene. Genome ...
Humoral and cell-mediated immune responses (CMI) were evaluated in subjects 3 and 6 years after primary and booster vaccination with either three-component acellular (Pa) or whole-cell (Pw) vaccines. Low anti-pertussis toxin (PT) antibody levels confirmed the absence of pertussis disease, consistent with ongoing protection. ...
Bicomponent, tricomponent and pertactin DTPa vaccines were tested in sublethal aerosol, and lethal and sublethal intranasal murine Bordetella pertussis respiratory challenge models. Pertactin and bicomponent vaccines induced protective immunity against lethality but with little or no bacterial clearance. Intranasal challenge discriminated in a reproducible, statistically ...
In the United States, co-administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and tetravalent meningococcal conjugate vaccine (MCV4) is recommended in adolescents. In this clinical study, 1341 adolescents received Tdap (Boostrix� GlaxoSmithKline) and MCV4 (Menactra�, Sanofi-Pasteur) simultaneously or ...
We have evaluated a guinea pig model for assessing the immunogenicity of Haemophilus influenzae type b (Hib) polysaccharide-protein conjugate vaccines, acellular pertussis vaccine and combination vaccines-consisting of tetanus toxoid (TT), diphtheria toxoid (DT), acellular pertussis vaccine and Hib-TT (Hib-T) ...
To study the pertussis-specific immune response of adolescents with different prevaccination schedules, we measured the humoral and cell-mediated immunity (CMI) to pertussis antigens before and after a five-component Tdap booster vaccination in 78 adolescents, who had previously received either five doses of a two-component acellular ...
NAVA's acellular pertussis vaccine is based on highly purified pertussis toxin (PT) inactivated with H(2)O(2). PT was analysed using advanced biochemical methodology including mass spectroscopy (LC/MS), yielding mass and peptide mapping information on the subunits. Pertactin, adenylate cyclase, and Fim 1, 2 were below detection levels ...
Objective: Acellular pertussis vaccine is safe and effective in adults. An explicit recommendation for pertussis booster vaccination in pediatric health care workers is based on the importance of health care workers as a potential source of infection for patients. However, limited information is available on the economic attractiveness ...
High rates of pertussis disease in adolescents suggest that additional boosting against pertussis would be beneficial. A combined acellular-pertussis-containing booster vaccine (dTpa-IPV; Boostrixtrade mark Polio, n =440) was compared to separately administered dTpa (Boostrixtrade mark) and inactivated polio virus (IPV; Imovax ...
... Pertussis Vaccine Adsorbed (DTaP) manufactured by Connaught Laboratories, Incorporated (CLI ... would require the submission of additional physical-chemical and ...
The combination vaccine diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (DTaP-IPV/Hib), which has been exclusively used in Canada for more than 10 years, is the first DTaP-based vaccine approved in the US that includes both poliovirus ...
A guinea pig model to assess the immunogenicity of a combination vaccine containing diphtheria, tetanus and acellular pertussis (DTaP) vaccine and Haemophilus influenzae type b (Hib) capsular polysaccharide conjugated to tetanus toxoid (HibT) was evaluated comparatively with the mouse immunogenicity test to study the effect of combining these antigens on ...
Although B. bronchiseptica efficiently infects a wide range of mammalian hosts and efficiently spreads among them, it is rarely observed in humans. In contrast to the many other hosts of B. bronchiseptica, humans are host to the apparently specialized pathogen B. pertussis, the great majority having immunity due to vaccination, infection or both. Here we explore whether ...
The modified intra-cerebral challenge assay for acellular pertussis vaccines is used in Japan, Korea, China and possibly other Asian countries as the potency assay for routine release of acellular pertussis (aP) and combination vaccines. National reference standards, typically of whole cell ...
Diphtheria tetanus acellular pertussis combined (DTaP) vaccines have been successfully used in Japan by controlling their potencies and toxicities with animal models. In accordance with the recent practical introduction of DTaP vaccines of various formulations, a question has been raised in other nations as to the efficacy of a quality control system based ...
BackgroundDespite the extensive use of efficacious vaccines, pertussis still ranks among the major causes of childhood mortality worldwide. Two types of pertussis vaccines are currently available, whole-cell, and the more recent acellular vaccines. Because of reduced reactogenicity and comparable efficacy acellular ...
Boostrix is a three-pertussis component, combined, reduced-antigen content tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine administered as a single intramuscular dose in adolescents or adults aged 10-64 years. Large, well designed trials conducted in the US in adolescents aged 10-18 years and in adults aged 19-64 ...
235 healthy 10-12 years old school children were randomly immunized with either a booster dose of diphtheria-tetanus-acellular pertussis (dTap) or diphtheria-tetanus (dT) vaccine. For this booster immunization designed for school children and adults, the quantities of Bordetella pertussis antigens in the dTap vaccine had been reduced ...
Pertussis continues to circulate in Chinese communities and older children, adolescents and adults are sources of infection for unprotected infants. Two studies conducted in Jiangsu Province in the People's Republic of China assessed the immunogenicity, reactogenicity and safety of Boostrix(), a combined reduced antigen content diphtheria-tetanus-acellular ...
In this study the development and evaluation of outer membrane vesicles (OMVs) obtained from Bordetella pertussis as vaccines against pertussis disease is described. SDS-PAGE, immunoblot techniques and gel electrophoresis associated to tandem mass spectrometry were used to describe the composition of the OMVs obtained from B. pertussis ...
Pertussis toxin (PT) is a major component of today's acellular whooping cough vaccines. The use of acellular vaccines is predicted to increase sharply in the near future. There is therefore a need to produce PT in a way that makes its purification as easy as possible. Our approach was to express all five PT subunits individually in ...
We compared an acellular (B type) pertussis-component diphtheria-tetanus-pertussis (DTP-Ac) vaccine containing equal amounts of filamentous hemagglutinin and lymphocytosis-promoting factor with a conventional whole-cell vaccine as the first booster immunization in 162 healthy children 15 to 24 months of age. Fewer local reactions ...
General practitioner consultation data were used to compare the reactogenicity in infants of a 5-in-1 acellular pertussis vaccine (DTaP(5)/Hib/IPV) introduced in the United Kingdom in 2004 to the 4-in-1 whole cell-pertussis vaccine (DTwP/Hib) that it replaced. For each vaccine the incidence in the week following vaccination was ...
Two randomized trials of 13-valent pneumococcal conjugate vaccine (PCV13) relative to PCV7 evaluated the immune responses of coadministered antigens comprising Infanrix(�) hexa/Infanrix(�)-IPV+Hib (diphtheria, tetanus, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b). After the 3-dose infant ...
Bordetella pertussis (Bp) is the causative agent of pertussis, a vaccine preventable disease occurring primarily in children. In recent years, there has been increased reporting of pertussis. Current pertussis vaccines are acellular and consist of Bp proteins including the major virulence ...
The aim of the study was to evaluate the effectiveness of the whole-cell pertussis vaccine produced locally and routinely used in Poland in the elimination of Bordetella parapertussis strains from the lungs and trachea of a mouse model. We found that the average protective effect against B. parapertussis in the lungs of mice immunized with the whole-cell ...
The prevalence of asthma and allergic disease has increased in many countries, and there has been speculation that immunization promotes allergic sensitization. Bordetella pertussis infection exacerbates allergic asthmatic responses. We investigated whether acellular pertussis vaccine (Pa) enhanced or prevented B. ...
In North America, children currently receive 5 doses of a combined diphtheria-tetanus-acellular pertussis vaccine between the ages of 2 months and 6 years. Although this schedule has reduced the incidence of childhood pertussis, it has not led to the development of herd immunity in the total population, largely because ...
Whooping cough is a respiratory disease caused by Bordetella pertussis. Since the 1950s in developed countries pertussis vaccinations are included in the national immunization program. However, antibody levels rapidly wane after both whole cell and acellular pertussis vaccination. Therefore protection against ...
Based on studies reporting specific antibody titers, it is recommended to vaccinate preterm infants against Bordetella pertussis according to their chronological age. However, as specific T-cell responses also are involved in the protection against B. pertussis, we have determined whether highly preterm infants (<31 weeks) are able to mount these immune ...
Mice deficient for the inhibitory G protein subunit ?2 (G?i2?/?) spontaneously develop a progressive inflammatory bowel disease resembling ulcerative colitis, and have a T helper 1 (Th1)-dominated immune response prior to onset of colitis, which is further augmented after the onset of disease. The present study was performed to investigate whether the ...
Variation in Clinician Recommendations for Multiple Injections During Adoption of Inactivated Polio/content/full/107/4/e49; immunizations, vaccines, pro- vider practices, practice variation, inactivated polio vac- cine. ABBREVIATIONS. IPV, inactivated polio vaccine; DTaP, diphthe- ria-tetanus-acellular pertussis
-tetanus-acellular pertussis; HBV, hepatitis B vi- rus; IPV, inactivated polio vaccine; OPV, oral polio vaccine; MMR, measles protein conjugate vaccine [Hib-OMP]), hepatitis B vi- rus (HBV) vaccine, and measles-mumps-rubella (MMR. # Comvax (combination HBV-Hib conjugate vaccine, Merck, Whitehouse Station, NJ) was developed in late 1996
Since whooping cough is reemerging in the Netherlands from 1996 onwards, several changes in the national immunization program have been implemented regarding the pertussis vaccinations. The aim of this study is to investigate IgG responses in whole cell (wP) and acellular (aP) pertussis vaccine primed children following revaccination ...
Pertussis is an infectious disease of the respiratory tract that is caused by the gram-negative bacterium Bordetella pertussis. Although acellular pertussis (aP) vaccines are safe, they are not fully effective and thus require improvement. In contrast to whole-cell pertussis (wP) vaccines, aP ...
Interleukin-1 receptor-deficient (IL-1R?/?) mice are healthy despite being colonized by commensal microbes but are defective in defenses against specific pathogens, suggesting that IL-1R-mediated effects contribute to immune responses against specific pathogenic mechanisms. To better define the role of IL-1R in immunity to respiratory infections, we challenged ...
The Bordetella species are Gram-negative bacterial pathogens that are characterized by long-term colonization of the mammalian respiratory tract and are causative agents of respiratory diseases in humans and animals. Despite widespread and efficient vaccination, there has been a world-wide resurgence of pertussis, which remains the leading cause of vaccine-preventable death in ...
Despite more than 50 years of vaccination, disease caused by the bacterium Bordetella pertussis persists, with rates increasing in industrialized countries over the past decade. This rise may be attributed to several factors, including increased surveillance, emergence of vaccine escape variants, waning immunity in adults, and the introduction of acellular ...
Comparing pertussis epidemiology over time and between countries is confounded by differences in diagnostic and notification practices. Standardized serological methods applied to population-based samples enhance comparability. Population prevalence of different levels of pertussis toxin IgG (PT IgG) antibody, measured by standardized methods, were ...
Bordetella pertussis pertactin (Prn) is an important attachment factor and protective immunogen, which serves as a component in most acellular pertussis vaccines (APVs). Here, we over-expressed recombinant Prn (r-Prn) without an affinity tag using an Escherichia coli expression system. Compared to the native Prn (n-Prn) from B. ...
This study evaluated the safety, tolerability, and immunogenicity of an investigational quadrivalent meningococcal conjugate vaccine, MenACWY-CRM, when administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis (Tdap) vaccine, in subjects aged 11 to 25 years. Subjects received either MenACWY-CRM and Tdap, MenACWY-CRM ...
A sixth dose of tetanus, diphtheria, acellular pertussis (Tdap) vaccine in adolescents might produce a differing reactogenicity and/or immunogenicity response depending on the composition of the 5 prior doses of DTaP or DT-whole cell pertussis (DTwP) vaccine. Reactions and immune responses following receipt of the Sanofi Pasteur ...
BackgroundBordetella pertussis is a causative agent of pertussis or whooping cough in humans. Pertactin (Prn), fimbriae 2 (Fim2) and fimbriae 3 (Fim3) of B. pertussis are important virulence factors and immunogens which have been included in some acellular pertussis vaccines. In this present ...
In an effort to devise a safer and effective pertussis acelullar vaccine, outer membrane vesicles (OMVs) were engineered to decrease their endotoxicity. The pagL gene from Bordetella bronchiseptica, which encodes a lipid A 3-deacylase, was expressed in Bordetella pertussis strain Tohama I. The resulting OMVs, designated OMVs(BpPagL), contain tetra- instead ...
P.69 pertactin (P.69 Prn), an adhesion molecule from the causative agent of pertussis, Bordetella pertussis, is present in cellular and most acellular vaccines that are currently used worldwide. Although both humoral immunity and cellular immunity directed against P.69 Prn have been implicated in protective immune mechanisms, the ...
BackgroundThe incidence of reported adolescent and adult pertussis continues to rise in the United States. Acellular pertussis vaccines for adolescents and adults have been developed and may be available soon for use in the U.S. Our objectives were: (1) to describe patient valuations of pertussis disease and ...
Annual vaccination with trivalent influenza vaccine (TIV), and a single dose of tetanus toxoid-reduced diphtheria toxoid-acellular pertussis (Tdap) vaccine, are both recommended for adults in the US. This study was conducted to obtain information on the safety and immunogenicity of co-administered TIV and a Tdap vaccine (Boostrix) in US adults. The ...
In a clinical trial, adolescents who had received a booster dose of reduced dose diphtheria-tetanus-5-component acellular pertussis vaccine (Adacel, Tdap) 5 years earlier maintained increased antibody concentrations to all antigens compared with pre-vaccination values. Observed data were applied to several mathematical models designed to predict further ...
Sera from 96 young children in a vaccine trial were analysed for kinetics of ELISA IgG anti-pertussis toxin (anti-PT) after a laboratory-verified pertussis infection. The antibody decay curves after infection were biphasic and similar in shape to those after vaccination. The change from a rapid to a slower decay after the peak occurred about 4-5 months ...
We compared immunogenicity and reactogenicity of a single dose of DTaP vaccine (containing tetanus and diphtheria toxoids and four acellular pertussis antigens) with conventional Td- or d-vaccines in 180 German adults. Antibody values against diphtheria and tetanus toxin and against the pertussis antigens fimbriae (FIM), filamentous ...
In a surveillance programme undertaken from 1997 through 2004, Bordetella pertussis isolates and clinical information were collected after introduction of acellular pertussis vaccines (Pa) in 1996. Changes in the B. pertussis population were studied in three incidence peaks: 1999-2000, 2002 and 2004. Available ...
The aim of this assessor-blinded trial was to compare the immunogenicity and reactogenicity of a candidate diphtheria, tetanus toxoids and acellular pertussis vaccine with reduced antigen content for diphtheria and pertussis (dTpa) with a licensed reduced adult-type diphtheria-tetanus vaccine Td (reduced diphtheria content) and with an ...
BackgroundCurrent and past pertussis epidemiology in the two parts of Germany is compared in the context of different histories of vaccination recommendations and coverage to better understand patterns of disease transmission.MethodsAvailable regional pertussis surveillance and vaccination coverage data, supplemented by a literature search for published ...
The American Academy of Pediatrics and the Centers for Disease Control and Prevention are amending previous recommendations and making additional recommendations for the use of tetanus toxoid, reduced-content diphtheria toxoid, and acellular pertussis vaccine (Tdap). Review of the results from clinical trials and other studies has revealed no excess ...
An international collaborative study (coded BSP083) was performed under the aegis of the Biological Standardisation Programme supported by the Council of Europe and the European Commission, with the aim of replacing the in vivo challenge assays for potency determination of combined acellular pertussis (aP) vaccines by a refined procedure also allowing ...
adults. Abbreviations for Vaccines updated Mar 2011 Vaccine Abbreviation* Trade Name Diphtheria, tetanus and pertussis-containing vaccines Diphtheria and tetanus toxoids adsorbed...
Duration of vaccine-induced immunity plays a key role in the epidemiology and in the pattern of transmission of a vaccine-preventable disease. In the case of whooping cough, its re-emergence has been attributed, at least partly, to the waning of immunity conferred by current pertussis vaccines. We have recently developed a highly attenuated live vaccine, named BPZE1, which has ...
Frequent occurrence of whooping cough in vaccinated populations suggests limited duration of vaccine-induced immunological memory. To investigate peculiarities in B cell memory specific for pertussis antigens P.69 pertactin (P.69 Prn), pertussis toxin (Ptx) and filamentous hemagglutinin (FHA), we monitored the induction and maintenance of specific serum ...
Waning vaccine-induced immunity against Bordetella pertussis is observed among adolescents and adults. A high incidence of pertussis has been reported in this population, which serves as a reservoir for B. pertussis. A fifth dose of reduced antigen of diphtheria-tetanus-acellular-pertussis and inactivated polio ...
The cost of a six-dose pertussis immunization programs for children and adolescents is investigated in relation to estimators of the price of acellular vaccine, the value of a child's life, levels of vaccination rate and discount rates. We compare the cost of the program maintained over time at 90% with three alternative strategies, each involving a ...
Under the National Childhood Vaccine Injury Act (42 U.S.C section 300aa-26), the CDC must develop vaccine information materials that health care providers, either public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 13, 1996, CDC published a notice in the Federal Register (61 FR 48597) seeking public comment on ...
UV irradiation was shown to induce efficient transfer of radiolabel from nicotinamide-labeled NAD to a recombinant protein (C180 peptide) containing the catalytic region of the S-1 subunit of pertussis toxin. Incorporation of label from (3H-nicotinamide)NAD was efficient (0.5 to 0.6 mol/mol of protein) relative to incorporation from (32P-adenylate)NAD (0.2 mol/mol of protein). ...
Energy Citations Database
Two types of serological assays are commonly used for the assessment of pertussis vaccine-induced antibodies; the Chinese hamster ovary cell (CHO cell) assay and the immunoglobulin G (IgG) anti pertussis toxin (PT) enzyme-linked immunosorbent assay (IgG anti-PT ELISA). Recently, both the techniques have been modified to improve performance with sera with ...
Pertussis, or whooping cough, is a major public health problem in the United States, with the incidence of disease and its associated complications having significantly increased in the adolescent and adult populations. These populations serve as the major transmission source of the disease to young infants, a group that is at the highest risk of severe morbidity and mortality ...
Pertussis is still among the principal causes of death worldwide, and its incidence is increasing even in countries with high vaccine coverage. Although all age groups are susceptible, it is most severe in infants too young to be protected by currently available vaccines. To induce strong protective immunity in neonates, we have developed BPZE1, a live attenuated Bordetella ...
Although vaccines against Bordetella pertussis, the causative agent of whooping cough, have been in use for over 50 y, the disease has remained endemic and is still a public health problem in many countries. It has been shown that antibody titres against pertactin, which is 1 of the exposed virulence factors of pertussis, correlate with protection and ...
In a previous study, it was found that the antibody response to a nonvaccine pertussis antigen in children who were vaccine failures was reduced compared with the response in nonvaccinated children who had pertussis. In two acellular pertussis vaccine efficacy trials in Sweden, we studied the convalescent-phase ...
Covaxis (also licensed as Triaxis or Adacel in individual countries) is a combined tetanus toxoid, reduced diphtheria toxoid, five component acellular pertussis (namely detoxified pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) vaccine for the prevention of diphtheria, tetanus, and ...
Covaxis� (also licensed as Triaxis� or Adacel� in individual countries) is a Tdap? (i.e. combined tetanus toxoid, reduced diphtheria toxoid, five component acellular pertussis [namely detoxified pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3]) vaccine for the prevention of diphtheria, tetanus, ...
Pertussis toxin (PTx) is a major virulence factor produced by Bordetella pertussis. In its detoxified form (PTd), it is an important component of acellular pertussis vaccines although some residual PTx activity may likely be present because of the limitations of the detoxification processes used. Furthermore, ...
We provided CDC recommended postpartum tetanus, diphtheria, acellular pertussis (Tdap) immunization to medically underserved, uninsured women in Houston through a standing order protocol. From January 7-April 30, 2008, 1129 of 1570 (72%) postpartum women (93% Hispanic; 11% < or = 19 years) received Tdap before hospital discharge. Tdap uptake was 96.2% ...
Combination vaccines allow the administration of multiple vaccine antigens without the need for multiple injections. Recently, a combined diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated poliomyelitis vaccine (DTaP-IPV), Kinrix, has been licensed in the USA for use as the fifth DTaP dose and fourth IPV dose in children 4-6 years of ...
Our population-based study among HMO members under seven years of age in 1993-2000 showed that frequency of diphtheria and tetanus toxoid vaccine (DT) use declined significantly following the introduction of acellular pertussis-containing (DTaP) vaccine. We also observed changes in indications for DT following the transition to DTaP among children under ...
The author reviews the use of mixed diphtheria-pertussis-tetanus antigens in the light of the information which has become available in recent years. When diphtheria toxoid and tetanus toxoid, adsorbed or unadsorbed, are added to either plain or adsorbed pertussis vaccine, a satisfactory level of diphtheria ...
The Asia Pacific Pediatric Association Vaccinology Update 2010 was held in Mumbai on November 13-14, 2010 to discuss the latest information on burden of infectious diseases, recent developments in vaccines and their impact on immunization practices against infectious diseases occurring in Indian children. During the conference the importance of including conjugate Haemophilus influenzae type b ...
A phase 3 randomized, multicenter study evaluated the safety and immunogenicity of a combined diphtheria, tetanus, 5-component acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b conjugate vaccine (DTaP(5)-IPV/Hib) administered at the same visit with 7-valent pneumococcal conjugate vaccine (PCV7, concurrent group) or at separate ...
Applicability of the endotoxin test to diphtheria-tetanus-acellular pertussis combined (DTaP) vaccines was examined. We found some DTaP vaccines that strongly interfered with Limulus amoebocyte lysate (LAL) activity of endotoxin without affecting lethal activity of endotoxin in D-galactosamine-treated mice. LAL activity that was interfered in such vaccines ...
BackgroundPertussis is a highly communicable, vaccine-preventable respiratory infection. Immune response against this disease can be induced by infection or vaccination. Protection after childhood vaccination is minimal after ten years. Our aim was to assess pertussis immunity state in a population of healthy young medical students.MethodsIn this ...
The European Pharmacopoeia (Ph. Eur.) and the World Health Organisation (WHO) require the performance of extensive quality and safety control testing before the release on the market of vaccine products for human use. Safety testing with regard to residual pertussis toxin (PT) in acellular pertussis combination vaccines is performed ...
... 5011.141 per 100.000 0.000 years 100.000 254,511 D.mlD 2000 0.00 1.~.110 MIlIl 7114.555 0.000 20lll 0.00 3,072.307 O.DOIl 1,536,la3 0.00lI 2011 o.aa 5,140.3a2 ...
We report an incidence of a 3-month-old infant who developed femoral neuropraxia after vaccination (diphtheria, tetanus and acellular pertussis/inactivated poliovirus/haemophilus influenzae type B vaccine) in the thigh. To the best of our knowledge, femoral nerve injury after vaccination has not been reported in the literature before. However, this baby ...
To add new insight to our previous work on the molecular epidemiology of Bordetella pertussis in Argentina, the prn and ptxS1 gene sequences and pulsed-field gel electrophoresis (PFGE) profiles of 57 clinical isolates obtained during two periods, 1969 to 1989 and 1997 to 2006, were analyzed. Non-vaccine-type ptxS1A was detected in isolates obtained since 1969. From 1989 on, a ...
Whooping cough, caused by Bordetella pertussis, is reemerging in the vaccinated population. Antibody levels to pertussis antigens wane rapidly after both whole-cell (wP) and acellular pertussis (aP) vaccination and protection may largely depend on long-term B- and T-cell immunity. We studied the effect of wP and aP ...
Background.?Because adolescents and adults act as a primary source of pertussis infection for infants, vaccination of mothers immediately postpartum is a potential strategy to reduce transmission (cocoon strategy). For this to be effective, high levels of antibodies must be achieved rapidly after vaccination. We sought to determine whether the antibody response to ...
OBJECTIVEThe safety, immunogenicity and lot consistency of a fully liquid, five-component acellular pertussis combination vaccine, comprised of diphteria, tetanus and acellular pertussis, inactivated polio vaccine, Haemophilus influenzae type b (DTaP-IPV-Hib [Pediacel, sanofi pasteur, Canada]) were assessed and ...
Immunogenicity data for the pertussis components of the French diphtheria-tetanus-two component acellular pertussis vaccine (DTaP(2Fr)) obtained after primary series of immunizations were compiled from 75 study groups comprising 36 clinical trials or vaccination programs conducted between 1987 and 2006. DTaP(2Fr) vaccine was ...
Antibody decay after a single dose of acellular pertussis vaccine containing 25 microg of pertussis toxin (PT), 25 microg of filamentous hemagglutin (FHA), and traces of pertactin (PRN) was monitored in health-care workers. Blood was sampled 4 weeks (n = 246), 1 year (n = 187), 2 years (n = 53), 3 years (n = 134), and 4 years (n = 37) ...
Despite over 50 years of population-wide vaccination, whooping cough incidence is on the rise. Although Bordetella pertussis is considered the main causative agent of whooping cough in humans, Bordetella parapertussis infections are not uncommon. The widely used acellular whooping cough vaccines (aP) are comprised solely of B. ...
The current diphtheria-tetanus-pertussis (DTP) pediatric vaccine is produced from the corresponding pathogenic bacteria Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis; five injected doses of DTaP (acellular) vaccine are required for every child in the standard US vaccination schedule. Because the vaccine is ...
Owing to their low reactogenicity, confirmed efficacy and availability in combination vaccines, acellular pertussis (aP)-inactivated poliovirus (IPV) combined vaccines are now included in various national immunization programs worldwide. We provide an overview of 16 years of clinical experience with a diphtheria (D), tetanus (T), aP, IPV and Haemophilus ...
Bordetella pertussis-specific antibodies can be detected by enzyme-linked immunosorbent assays (ELISAs) or multiplex immunoassays. Assays use purified or mixed antigens, and only pertussis toxin (PT) is specific for B. pertussis. The interpretation of results can be based on dual-sample or single-sample serology using one or two ...
