Spotlight on Tdap5 Vaccine (Covaxis®) as a Single-Booster Immunization for the Prevention of Tetanus, Diphtheria, and Pertussis
- First Online:
Covaxis® (also licensed as Triaxis® or Adacel® in individual countries) is a Tdap5 (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, and pertussis. It is approved for use in Europe as a single intramuscular booster dose in children (aged ≥4 years), adolescents, and adults, and in the US it is approved for use in individuals aged 11–64 years.
In large, randomized, controlled clinical trials conducted in the UK and North America, a single intramuscular booster dose of Covaxis® induced robust immune responses for all of its component antigens when given to children (aged ≥4 years), adolescents, and adults. In addition, Covaxis® vaccine was safe and generally well tolerated in terms of solicited and unsolicited local injection-site and systemic adverse events, most of which were of mild intensity and resolved without sequelae. Furthermore, the immunogenicity of each individual component and the reactogenicity of Covaxis® vaccine in children, adolescents, and adults was generally similar to that of comparator vaccines.
Despite being a vaccine-preventable disease and having >90% primary vaccination coverage worldwide, pertussis remains uncontrolled, particularly amongst adolescents and adults. Given the changing epidemiology of pertussis and the requirement to reduce infection in adolescents and adults (including healthcare workers) and thereby prevent transmission of the disease from these individuals to very young infants, the new ‘cocoon strategy’ recommended in current vaccination guidelines has become a key strategy in the management of morbidity and mortality associated with pertussis. This strategy focuses on the immunization of healthcare workers, and the parents and family members of infants who are too young to have undergone primary immunization, so as to prevent the transmission of pertussis to these young at-risk infants. The implementation of the ‘cocoon strategy’ may finally give countries the ability to control pertussis infections in these at-risk infants and ultimately provide the desired herd immunity against pertussis. In line with this strategy, a booster dose of Covaxis® vaccine provides a valuable option to reduce pertussis morbidity and mortality, and to maintain seroprotection against diphtheria and tetanus in children (aged ≥4 years), adolescents, and adults.
- 1.Di Pasquale A, Wolter J, Schuerman L. Management of pertussis in adolescents and adults: the role of a reduced-antigen content combined diphtheria-tetanusacellular pertussis (dTpa) vaccine. J Prevent Med Hygiene 2005; 46(1): 33–41Google Scholar
- 2.Sanofi Pasteur MSD SNC. Summary of product characteristics (Covaxis®): European mutual recognition procedure. Lyon: Sanofi Pasteur MSD SNC, 2009 DecGoogle Scholar
- 3.Sanofi Pasteur Limited. Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Adacel®): US prescribing information. Swiftwater (PA): Sanofi Pasteur Limited, 2009Google Scholar
- 5.Langley JM, Predy G, Guasparini R, et al. An adolescent-adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis vaccine has comparable immunogenicity but less reactogenicity in children 4–6 years of age than a pediatric formulation acellular pertussis vaccine and diphtheria and tetanus toxoids adsorbed combined with inactivated poliomyelitis vaccine. Vaccine 2007; 25(6): 1121–5PubMedCrossRefGoogle Scholar
- 11.Halperin SA, Smith B, Russell M, et al. Adult formulation of a five component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults. Pediatr Infect Dis J 2000; 19(4): 276–83PubMedCrossRefGoogle Scholar
- 12.Vesikari T. Concomitant vaccination of quadrivalent HPV 6/11/16/18 vaccine (Gardasil®) with either Repevax® or Menactra®/Adacel® in healthy adolescents 10–17 years of age [abstract plus poster]. 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2009 Jun 9–13; BrusselsGoogle Scholar
- 14.McNeil SA, Noya F, Dionne M, et al. Comparison of the safety and immunogenicity of concomitant and sequential administration of an adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis (Tdap) vaccine and trivalent inactivated influenza vaccine in adults. Vaccine 2007; 25(17): 3464–74PubMedCrossRefGoogle Scholar
- 15.Bailleux F, Coudeville L, Kolenc-Saban A, et al. Predicted long-term persistence of pertussis antibodies in adolescents after an adolescent and adult formulation combined tetanus, diphtheria, and 5-component acellular pertussis vaccine, based on mathematical modeling and 5-year observed data. Vaccine 2008; 26(31): 3903–8PubMedCrossRefGoogle Scholar
- 17.Khromava A, Mahmood A, Johnson DR, et al. Immunization of pregnant women with tetanus diphtheria-acellular pertussis vaccine: 29 months of data from the ADACEL Vaccine Pregnancy Registry [abstract no. 443]. Pharmacoepidemiol Drug Saf 2008; 17: s194–5Google Scholar