1060. Persistence of Bactericidal Activity at 4 Years After 2 Primary Doses of a Recombinant, 4-Component, Meningococcal Serogroup B Vaccine (4CMenB) and Response to a Booster Dose in Adolescents and Young Adults
Session: Poster Abstract Session: Assorted Pediatric Vaccines
Friday, October 6, 2017
Room: Poster Hall CD
Posters
  • 1060-IDWeekPOSTER.pdf (824.1 kB)
  • Background: This phase 3b, open label, controlled, multi-center, extension study (NCT02446743) assessed the persistence of bactericidal activity at 4 years post-primary vaccination with a recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) in adolescents who participated in the parent study NCT01423084 and their response to a booster dose, compared to that in vaccine-naïve healthy controls.

    Methods: Adolescents and young adults previously primed with 4CMenB (2 doses; following a 0,1-month schedule) in study NCT01423084 (group 3B) and vaccine-naïve 15–22 year olds (group B0_1) were enrolled. Group 3B received a booster dose of 4CMenB at 4 years post-primary vaccination; group B0_1 received 2 catch-up doses of 4CMenB (following a 0,1-month schedule). Antibody persistence (primary objective) was evaluated at 4 years post-primary vaccination (in group 3B) versus baseline (in group B0_1) using human serum bactericidal assay (hSBA), in terms of geometric mean titer (GMT) and percentage (%) of individuals with hSBA titer at least 4. Immune responses at 1 month after booster dose (in group 3B) versus those at 1 month after first dose (in group B0_1) were also assessed.

    Results: In group 3B, antibody levels declined from 1 month to 4 years post-primary vaccination against all antigens except NHBA, but were higher than in group B0_1 at baseline (Table), with a GMT ratio ≥1.3 and a difference in % of individuals with hSBA titer at least 4 of ≥9%. After one dose of 4CMenB (booster in 3B or first dose in B0_1), GMTs increased (≥4.6-fold in group 3B; ≥2.3-fold in group B0_1), and ≥94% of participants in group 3B and ≥41% of participants in group B0_1 had hSBA titer at least 4 (Table).

    Conclusion: Antibody levels in adolescents and young adults primed with 4CMenB waned over time but were higher at 4 years post-primary vaccination than for vaccine-naïve individuals at baseline. A booster dose of 4CMenB in vaccine-primed individuals elicited higher immune responses than one dose of 4CMenB in vaccine-naïve individuals.

    Funding: GlaxoSmithKline Biologicals SA

    Terry Nolan, MBBS PhD1, Hartley Garfield, MD2, Anil Gupta, MD CCFP FCFP2, Murdo Ferguson, MBChB3, Helen Marshall, MD MBBS MPH4, Diego D'Agostino, MSc5 and Daniela Toneatto, MD6, (1)University of Melbourne and Murdoch Children's Research Institute, Melbourne, Victoria, Australia, (2)The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada, (3)Colchester Research Group, Truro, NS, Canada, (4)University of Adelaide and Women’s and Children’s Hospital, Adelaide, South Australia, Australia, (5)GSK, Amsterdam, Netherlands, (6)GSK, Siena, Italy

    Disclosures:

    T. Nolan, GSK group of companies: Research Contractor and Scientific Advisor , Research grant
    Pfizer: Research Contractor , Research grant

    H. Garfield, Novartis/GSK group of companies: Investigator , Research support

    A. Gupta, Novartis/GSK group of companies: Investigator , payment for research related activities

    M. Ferguson, GSK group of companies: Investigator , I receive salary from CRG. CRG has contracts with GSK

    H. Marshall, GSK group of companies: Grant Investigator and Investigator , Research grant
    Pfizer: Grant Investigator and Investigator , Research grant
    Sanofi Pasteur: Grant Investigator , Research grant
    Novavax: Investigator , Research grant

    D. D'Agostino, GSK group of companies: Consultant , Consulting fee

    D. Toneatto, GSK group of companies: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. PDT, Wednesday Oct. 4th with the exception of research findings presented at the IDWeek press conferences.