Combined Tetanus, Diphtheria, and 5-Component Pertussis Vaccine for Use in Adolescents and Adults

Pichichero, Michael E.; Rennels, Margaret B.; Edwards, Kathryn M.; Blatter, Mark M.; Marshall, Gary S.; Bologa, Monica; Wang, Elaine; Mills, Elaine L.

doi:10.1001/jama.293.24.3003

Cited by 123 publications

(128 citation statements)

References 14 publications

(17 reference statements)

Supporting

Mentioning

114

Contrasting

Unclassified

Order By: Relevance

“…Subjects were enrolled at four clinical trial centres in France (Gabriel Montpied Hospital, Clermont-Ferrand; Cochin Hospital, Paris; Saint-Eloi Hospital, Montpellier; and DermscanPharmascan, Villeurbanne). Only healthy male and female volunteers meeting study requirements and the following inclusion criteria were included: (1) aged between 18 and 40 years; (2) written evidence of vaccination history and having received between five and eight doses of tetanus, diphtheria and poliovirus vaccine by the age of 18 years, as recommended in the French vaccination calendar; (3) the last dose of separate or combined diphtheria and/or tetanus and/or poliovirus and Halperin et al 18,19 Calculation assumed no inter-group difference. On this basis and with an expected drop-out rate of 5%, 500 inclusions (250 per group) were expected to give accuracy (95% CI width) of 2.9-8.7% (depending on the proportions of AEs) for the 95% CI of the inter-group difference.…”

Section: Methodsmentioning

confidence: 99%

Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: A placebo-controlled trial

Beytout

Launay²,

Guiso³

et al. 2009

Human Vaccines

View full text Add to dashboard Cite

IntroductionPertussis ("whooping cough") is potentially fatal in infants. 1 Over the last 50 years, infant vaccination programs have significantly reduced the clinical incidence of pertussis in industrialized countries. 1 However, protection against the infectious agent-the bacterium Bordetella pertussis-is only effective for about ten years. An increase in the number of new cases has been observed in vaccinated adolescents and adults, who may contaminate infants who are not yet fully immunized. [2][3][4][5] Since 1998, the administration of a pertussis booster at age 11-13 years has been recommended in France and other countries in Europe and North America. Subsequent recommendations established in 2004 have promulgated the use of a second booster in adults who are in contact with infants, these include health professionals in contact with children who are too young to have received three pertussis vaccinations (medical and paramedical staff in maternity, neonatal and pediatric departments managing infants, and medical and paramedical students), adults who are liable to become parents in the near future, and members of the household of a pregnant woman (children whose vaccinations are not up-to-date or adults who have not been vaccinated within the last 10 years). 2,[6][7][8] The administration of the pertussis booster in adults is complicated by the lack of any non-combined acellular pertussis vaccine. All available pertussis-booster vaccines for use in adults associate diphtheria, tetanus and/or poliovirus antigens. In France, there are currently two such vaccines: REPEVAX ® [manufactured by Sanofi Pasteur and licensed by Sanofi Pasteur MSD in the European Union (EU) and as ADACEL Polio ® outside the EU] and BOOSTRIX-TETRA ® (GlaxoSmithKline). 9,10 Both are combined adsorbed tetanus, diphtheria (adult formulation), acellular pertussis, inactivated poliovirus vaccines (Tdap-IPV). Inactivated poliovirus vaccine (IPV) has been used since the beginning of polio vaccination in France, and is included in all booster formulations (administered every 10 years in adults). Results: The safety of Tdap-IPV was similar when Tdap-IPV vaccine was administered one month after either Td-IPV or placebo: at seven days, 85.1% versus 93.4% subjects reported at least one reaction at the injection site, mainly pain (82.6% versus 92.1%); 40.5% versus 45.0%, at least one systemic AE (mainly headache: 26.4% versus 26.0%); fever concerned 1.7% of both groups. No serious vaccine-related AEs were reported. Both safety profiles corresponded to documented product characteristics.Conclusions: Tdap-IPV may be administered to adults one month after Td-IPV without exacerbating post-vaccination sideeffects.

show abstract

Section: Methodsmentioning

confidence: 99%

Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: A placebo-controlled trial

Beytout

Launay²,

Guiso³

et al. 2009

Human Vaccines

View full text Add to dashboard Cite

show abstract

“…10 There may be an explanation for this situation in that protection against pertussis would appear to be multifactorial, involving humoral, cellular and mucosal immunity. Thus, studies that include the different types of immunity for long-term assessment of the protection induced by pertussis vaccines are considered to be necessary.…”

Section: Natural Immunological Response and Response To Immunizationmentioning

confidence: 99%

“…Thus, studies that include the different types of immunity for long-term assessment of the protection induced by pertussis vaccines are considered to be necessary. 10,11 Wendelboe et al 12 warned about various factors that may make it difficult to assess the persistence of pertussis vaccine induced immunity, as well as to limit the comparability among different studies, such as: the existence of various types of vaccines, alteration in vaccine compositions, use of non-uniform schemes, divergence in case definitions and presence of problems in the epidemiologic surveillance system.…”

Section: Natural Immunological Response and Response To Immunizationmentioning

confidence: 99%

“…24,42 Furthermore, there are other microorganisms responsible for symptoms similar to those caused by B. pertussis, leading to a differential diagnosis. 10,43 The following will depend on elucidating the diagnosis:…”

Section: Laboratory Diagnosismentioning

confidence: 99%

“…Pichichero et al 10 mentioned that the major impact of the disease on adults is not related to gravity or to lethality. In this group, the major problem is the loss of working days and reduction of productivity; c) Reliability of statistical data.…”

Section: Final Considerationsmentioning

confidence: 99%

See 2 more Smart Citations

Vacina acelular contra pertússis para adolescentes

Carvalho¹,

Pereira²

2006

J. Pediatr. (Rio J.)

View full text Add to dashboard Cite

Background: The use of whole-cell pertussis vaccine has led to a significant decline in incidence of the disease among children. This change in the epidemiological profile led to an increased number of cases among teenagers and adults, as a result of loss of immunity to the disease or vaccine after approximately 10 years. An increased number of cases was also observed among non-immunized or partially immunized infants. Licensure of the DTP vaccine against diphtheria, tetanus, and acellular pertussis formulated specifically for patients over 10 years of age (Tdap) suggests the possibility of controlling pertussis in the most affected age groups over the past few years.Sources of data: Data were collected from MEDLINE. The research was limited to the period between January 1995 and January 2006. Summary of the findings:In some countries there are two Tdap vaccines licensed for patients over 10 years of age. One of them contains five immunogenic components of Bordetella pertussis (pertussis toxin, filamentous hemagglutinin, fimbriae 2 and 3, and pertactin), and the other contains three components (pertactin, filamentous hemagglutinin, and inactivated pertussis toxin), the latter being the only one licensed in Brazil up to now. Although the composition of the two vaccines differs, studies show that they have similar effectiveness and immunogenicity. Some authors, however, emphasize that it is difficult to make a precise assessment of the immunological response to the vaccine and its duration. Several countries currently recommend the use of Tdap vaccine for adolescents. Canada has extended the target population up to 54 years of age. The guideline is that this group should receive one dose of the vaccine to reinforce the basic immunization scheme. This is based on study results that show that the vaccine-induced immunity lasts for around 6 to 12 years. Assessments of the economic impact of routine use of the vaccine in adolescents showed a positive cost-benefit ratio. Results of the epidemiological impact depend on the quality of diagnosis so that data reflect the reality of the disease. Conclusions:Although some questions remain to be clarified, the literature indicates the possibility of solving the reappearance of whooping cough (pertussis) with the use of Tdap vaccine. Perhaps the strategy of using a second booster dose in adolescence to replace the double diphtheria and tetanus vaccine should be adopted immediately.J Pediatr (Rio J). 2006;82(3 Suppl):S15-24: Pertussis, whooping cough, pertussis vaccine, vaccine for adolescents, acellular vaccine.

show abstract

Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months<subtitle>A Randomized Trial</subtitle>

Marano

Plikaytis²,

Martin³

et al. 2008

JAMA

View full text Add to dashboard Cite

IMPLER AND BETTER TOLERATED regimens for vaccination with anthrax vaccine adsorbed (AVA) are needed. Anthrax vaccine adsorbed (BioThrax, Emergent Bio-Solutions Inc, Lansing, Michigan) is currently the only licensed anthrax vaccine in the United States and the only licensed aluminum-adjuvant vaccine administered subcutaneously (SQ). 1-3 The principal immunogen of AVA is the anthrax toxin component protective antigen (PA). 4 The licensed AVA vacci-Author Affiliations are listed at the end of this article. The Anthrax Vaccine Research Program Working Group members are listed at the end of this article.

show abstract

Combined Tetanus, Diphtheria, and 5-Component Pertussis Vaccine for Use in Adolescents and Adults

Cited by 123 publications

References 14 publications

Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: A placebo-controlled trial

Safety of Tdap-IPV given one month after Td-IPV booster in healthy young adults: A placebo-controlled trial

Vacina acelular contra pertússis para adolescentes

Effects of a Reduced Dose Schedule and Intramuscular Administration of Anthrax Vaccine Adsorbed on Immunogenicity and Safety at 7 Months<subtitle>A Randomized Trial</subtitle>

Contact Info

Product

Resources

About