Journal of Vaccines & Vaccination

Journal of Vaccines & Vaccination
Open Access

ISSN: 2157-7560

Abstract

Immunogenicity and Safety of Combined Tetanus, Reduced Diphtheria, Acellular Pertussis Vaccine when Co-Administered with Quadrivalent Meningococcal Conjugate and Human Papillomavirus Vaccines in Healthy Adolescents

Roberto Gasparini, William Johnston, Michele Conversano, Alan Garscadden, David Alexanderian, Noemi Giglioli, Sandra Percell, Linda Han and Igor Smolenov

Objective: Current United States immunization recommendations for adolescents include vaccines against tetanus, diphtheria and pertussis (Tdap), human papillomavirus (HPV), and Neisseria meningitidis serogroups A, C, W-135, and Y. In this Phase IV study, we primarily investigated the impact of concomitant administration of a quadrivalent meningococcal CRM197-conjugate vaccine (MenACWY-CRM) with Tdap and HPV vaccines, in terms of immunogenicity to Tdap antigens and overall reactogenicity. Methods: A total of 801 healthy adolescents aged 10-18 years were randomized to one of two groups to receive either MenACWY-CRM or a placebo, co-administered with Tdap and a quadrivalent HPV vaccine (HPV4). Antibody responses to the Tdap antigens, as well as to meningococcal serogroups A, C, W-135, and Y, were assessed at one month post-vaccination. Safety and adverse events were monitored throughout the study. Results: One month post-vaccination, 95% and 99% of subjects in the MenACWY-CRM group had seroprotective antibody levels (≥1.0 IU/mL) against the diphtheria and tetanus toxoids, respectively, compared with 82% and 98% in the placebo group. Ratios of geometric mean concentrations of antibodies against pertussis antigens pertussis toxin, filamentous hemagglutinin and pertactin for the MenACWY-CRM group versus placebo were 1.01, 0.84, and 0.82, respectively. Predetermined non-inferiority criteria for immunological responses against all Tdap antigens were met. Co-administration of a single dose of MenACWY-CRM was well tolerated and elicited robust antibody responses against the four meningococcal serogroups, with 77%, 84%, 95% and 86% of subjects having seroprotective human complement serum bactericidal activity (titers ≥8) against serogroups A, C, W-135, and Y, respectively, one month post-vaccination. Conclusions: Collectively, these results demonstrate that the MenACWY-CRM, Tdap and HPV4 vaccines can be administered at the same visit without compromising Tdap immune responses or increasing reactogenicity. [The study is registered with ClinicalTrials.gov, number NCT01424644].

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