743. Immunogenicity of the Booster Dose of 2 Investigational Protein-based Pneumococcal Vaccine Formulations in Toddlers: a Phase II Randomized Trial
Session: Poster Abstract Session: Vaccines: New and Novel
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • GSK-IDWEEK 2016_e-poster 743.pdf (385.4 kB)
  • Background: We have previously shown that primary vaccination with 2 formulations of an investigational pneumococcal vaccine containing each of the highly conserved pneumococcal proteins pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) at either 10µg (PHiD-CV/dPly/PhtD-10) or 30µg (PHiD-CV/dPly/PhtD-30) combined with polysaccharide conjugates of 10-valent pneumococcal conjugate vaccine (PHiD-CV, GSK Vaccines [not licensed in USA]) induced robust immune responses in infants in Europe. Here, we present immunogenicity results following administration of a booster dose of these 2 vaccine formulations in the same study.

    Methods: In this phase II, multicenter, observer-blind trial (NCT01204658) in Europe, 576 infants aged 6–14 weeks were randomized 1:1:1:1  to receive primary and booster vaccinations (at ages 2, 3, 4 and 12–15 months) with either PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV or 13-valent pneumococcal conjugate vaccine (PCV13, Pfizer), co-administered with DTPa-HBV-IPV/Hib. Immune responses were assessed pre- and 1 month post-booster.

    Results: All vaccinees had post-booster anti-Ply and anti-PhtD antibody concentrations ≥ assay cut-off (12 and 17 EL.U/mL, respectively), except for PhtD in PHiD-CV vaccinees: 96.1% of toddlers. Increases in geometric mean antibody concentrations (GMCs) from pre- to post-booster timepoint were observed (table 1). For each of the 10 common vaccine pneumococcal serotypes, ≥96.9% of toddlers had post-booster antibody concentrations ≥0.2 μg/mL; GMCs are shown in table 1. Pneumococcal opsonophagocytic activity (OPA) seemed to be similar between PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30 and PHiD-CV recipients (except for 9V geometric mean OPA titers in PHiD-CV/dPly/PhtD-10 versus PHiD-CV group) (table 2). Post-booster anti-protein D GMCs tended to be lower in the protein-based formulations groups than in the PHiD-CV group (table 1).

    Conclusion: PHiD-CV/dPly/PhtD-10 and PHiD-CV/dPly/PhtD-30 induced booster responses to Ply and PhtD. No interference with immune responses to pneumococcal conjugates was observed when combining dPly and PhtD with the 10 PHiD-CV polysaccharide conjugates.

    Funding: GlaxoSmithKline Biologicals SA

     

     

    Roman Prymula, MD, PhD1, Leszek Szenborn, MD2, Sven-Arne Silfverdal, MD, PhD, MPH3, Jacek Wysocki, MD, PhD4, Piotr Albrecht, MD, PhD5, Magali Traskine, MSc6, Asparuh Gardev, MD6, Yue Song, MD, PhD6 and Dorota Borys, MD6, (1)University Hospital Hradec Králové, Hradec Králové, Czech Republic, (2)Department of Pediatric Infectious Diseases, Wroclaw Medical University, Wroclaw, Poland, (3)Umeå University, Umeå, Sweden, (4)University School of Medical Sciences & Regional Medical Center for Mother and Child, Poznan, Poland, (5)Medical University of Warsaw, Warsaw, Poland, (6)GSK Vaccines, Wavre, Belgium

    Disclosures:

    R. Prymula, GSK: Grant Investigator , Research grant

    L. Szenborn, GSK: I have served as principal investigator in clinical trials sponsored by GSK , Salary

    S. A. Silfverdal, GSK: Investigator , The study was financed by GSK to institution and no personal fee or honoraria was given

    J. Wysocki, GSK: Grant Investigator , investigator fee

    P. Albrecht, GSK: Investigator , Research support
    Pfizer: Grant Investigator , Educational grant and Research support

    M. Traskine, GSK: Employee , Salary

    A. Gardev, GSK: formerly employed by GSK , Salary at the time of GSK employment

    Y. Song, GSK: Consultant , Consulting fee

    D. Borys, GSK Biologicals: Employee and Shareholder , I have share options/shares of GSK Biologicals and Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.