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
Por:
Boutriau, D, Poolman, J, Borrow, R, Findlow, J, Domingo, J, Puig-Barbera, J, Baldo, J, Planelles, V, Jubert, A, Colomer, J, Gil, A, Levie, K, Kervyn, A, Weynants, V, Dominguez, F, Barbera, R and Sotolongo, F
Publicada:
1 ene 2007
Resumen:
An experimental bivalent meningococcal outer membrane vesicle (OMV) vaccine (B:4:P1.19,15 and BA: 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 vaccinehomologous/PorA-related strains but also against heterologous strains, indicating the presence of protective antigens in OMVs and confirming the potential of clinical cross-protection.
Filiaciones:
GlaxoSmithKline Biol, B-1330 Rixensart, Belgium.
Hlth Protect Agcy, Meningococcal Reference Unit, Manchester, Lancs, England.
Ctr Salud Nazaret, Valencia, Spain.
Vaccines Inst Valencia, Valencia, Spain.
Ctr Salud Publ, Grp Invest Atenc Primaria Castellon, Castellon, Spain.
Ctr Salud Publ, Castellon, Spain.
Ctr Salud Quart Poblet, Valencia, Spain.
Ctr Salud Paiporta, Valencia, Spain.
Ctr Salud Malvarosa, Valencia, Spain.
Ctr Salud Fuente San Luis, Valencia, Spain.
Univ Rey Juan Carlos, Madrid, Spain.
Ecole Sante Publ, Brussels, Belgium.
Finlay Inst, Havana, Cuba.
Green Published
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