Immunogenicity, reactogenicity, and safety of a P1.7b,4 strain-specific serogroup B meningococcal vaccine given to preteens.
Clin Vaccine Immunol
; 14(11): 1393-9, 2007 Nov.
Article
en En
| MEDLINE
| ID: mdl-17898183
ABSTRACT
New Zealand (NZ) has experienced a Neisseria meningitidis serogroup B epidemic since 1991. MeNZB, a strain-specific outer membrane vesicle vaccine made using an NZ epidemic strain isolate, NZ98/254 (B4P1.7b,4), from two manufacturing sites, the Norwegian Institute of Public Health (NIPH) and Chiron Vaccines (CV; now Novartis), was evaluated for safety, immunogenicity, and reactogenicity in this observer-blind trial with 8- to 12-year-old children. In year 1, cohort A (n = 302) was randomized 41 for receipt of NIPH-MeNZB or MenBvac (Norwegian parent vaccine strain 44/76; B15P1.7,16). In year 2, cohort B (n = 313) was randomized 41 for receipt of CV-MeNZB or NIPH-MeNZB. Participants all received three vaccinations 6 weeks apart. Local and systemic reactions were monitored for 7 days. Seroresponse was defined as a fourfold or greater rise in the serum bactericidal antibody titer from the baseline titer as measured by a serum bactericidal assay. Those with baseline titers of <14 required titers of >/=18 to serorespond. Intention-to-treat (ITT) and per protocol (PP) analyses are presented. In cohort A, 74% (ITT) and 73% (PP) of NIPH-MeNZB recipients demonstrated seroresponses against NZ98/254 after three doses, versus 32% (ITT and PP) of MenBvac recipients. In cohort B, seroresponses against NZ98/254 after three doses occurred in 79% (ITT and PP) of CV-MeNZB versus 75% (ITT) and 76% (PP) of NIPH-MeNZB recipients. Vaccines were tolerable, with no vaccine-related serious adverse events. In conclusion, the NZ strain meningococcal B vaccine (MeNZB) from either manufacturing site was immunogenic against New Zealand epidemic vaccine strain meningococci with no safety concerns when given in three doses to these 8- to 12-year-old children.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vacunas Meningococicas
/
Neisseria meningitidis Serogrupo B
/
Anticuerpos Antibacterianos
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Risk_factors_studies
Límite:
Child
/
Female
/
Humans
/
Male
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Clin Vaccine Immunol
Asunto de la revista:
ALERGIA E IMUNOLOGIA
/
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Año:
2007
Tipo del documento:
Article
País de afiliación:
Nueva Zelanda