Immunogenicity and Safety of Three Doses of a Bivalent (B:4:P1.19,15 and B:4:P1.7-2,4) Meningococcal Outer Membrane Vesicle Vaccine in Healthy Adolescents
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Published:2007-01
Issue:1
Volume:14
Page:65-73
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ISSN:1556-6811
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Container-title:Clinical and Vaccine Immunology
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language:en
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Short-container-title:Clin Vaccine Immunol
Author:
Boutriau Dominique12345, Poolman Jan12345, Borrow Ray12345, Findlow Jamie12345, Domingo Javier Diez12345, Puig-Barbera Joan12345, Baldó José María12345, Planelles Victoria12345, Jubert Angels12345, Colomer Julia12345, Gil Angel12345, Levie Karin12345, Kervyn Anne-Diane12345, Weynants Vincent12345, Dominguez Francisco12345, Barberá Ramon12345, Sotolongo Franklin12345
Affiliation:
1. GlaxoSmithKline Biologicals, Rixensart, Belgium 2. Meningococcal Reference Unit, Health Protection Agency, Manchester, United Kingdom 3. Centro de Salud Nazaret, Valencia, Spain 4. Vaccines Institute of Valencia, Valencia, Spain 5. Grupo de Investigación de Atención Primaria de Castellón, Centro de Salud Pública, Castellón, Spain
Abstract
ABSTRACT
An experimental bivalent meningococcal outer membrane vesicle (OMV) vaccine (B:4:P1.19,15 and B:4:P1.7-2,4) has been developed to provide wide vaccine coverage particularly of the circulating strains in Europe. A randomized, controlled phase II study (study identification number, 710158/002; ClinicalTrials.gov identifier number, NCT00137917) to evaluate the immunogenicity and safety of three doses of the OMV vaccine when given to healthy 12- to 18-year-olds on a 0-2-4 month (
n
= 162) or 0-1-6 month schedule (
n
= 159). A control group received two doses of hepatitis A and one of conjugated meningococcal serogroup C vaccine on a 0-1-6 month schedule (
n
= 157). Immune response, defined as a fourfold increase in serum bactericidal titer using a range of vaccine-homologous or PorA-related and heterologous strains, was determined for samples taken before and 1 month after vaccination; assays were performed at two laboratories. As measured at the GlaxoSmithKline (GSK) laboratory, the OMV vaccine induced an immune response against homologous or PorA-related strains (in at least 51% of subjects against strains of serosubtype P1.19,15 and at least 66% against strains of serosubtype P1.7-2,4) and against a set of three heterologous strains (in 28% to 46% of subjects). Both laboratories showed consistent results for immune response rates. The OMV vaccine had a similar reactogenicity profile for each schedule. Pain preventing normal activities occurred in approximately one-fifth of the subjects; this was significantly higher than in the control group. The immune responses induced by the bivalent OMV vaccine demonstrated the induction of bactericidal antibodies against the vaccine-homologous/PorA-related strains but also against heterologous strains, indicating the presence of protective antigens in OMVs and confirming the potential of clinical cross-protection.
Publisher
American Society for Microbiology
Subject
Microbiology (medical),Clinical Biochemistry,Immunology,Immunology and Allergy
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