Immunogenicity and Tolerability of Recombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules A Randomized Controlled Trial
Open Access
- 7 February 2012
- journal article
- research article
- Published by American Medical Association (AMA) in Jama-Journal Of The American Medical Association
- Vol. 307 (6), 573-582
- https://doi.org/10.1001/jama.2012.85
Abstract
Context In the absence of an effective vaccine, serogroup B Neisseria meningitidis (MenB) remains a major cause of invasive disease in early childhood in developed countries. Objective To determine the immunogenicity and reactogenicity of a multicomponent MenB vaccine (4CMenB) and routine infant vaccines when given either concomitantly or separately. Design, Setting, and Participants Phase 2b, multicenter, open-label, parallel-group, randomized controlled study of 1885 infants enrolled at age 2 months from August 2008 to July 2010 in Europe. Intervention Participants were randomized 2: 2: 1: 1 to receive (1) 4CMenB at 2, 4, and 6 months with routine vaccines (7-valent pneumococcal and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 4CMenB at 2, 4, and 6 months and routine vaccines at 3, 5, and 7 months; (3) 4CMenB with routine vaccines at 2, 3, and 4 months; or (4) routine vaccines alone at 2, 3, and 4 months. Main Outcome Measures Percentage of participants with human complement serum bactericidal activity (hSBA) titer of 1: 5 or greater against 3 MenB strains specific for vaccine antigens (NZ98/254, 44/76-SL, and 5/99). Results After three 4CMenB vaccinations, 99% or more of infants developed hSBA titers of 1: 5 or greater against strains 44/76-SL and 5/99. For NZ98/254, this proportion was 79% (95% CI, 75.2%-82.4%) for vaccination at 2, 4, and 6 months with routine vaccines, 86.1% (95% CI, 82.9%-89.0%) for vaccination at 2, 4, and 6 months without routine vaccines, and 81.7% (95% CI, 76.6%-86.2%) for vaccination at 2, 3, and 4 months with routine vaccines. Responses to routine vaccines given with 4CMenB were noninferior to routine vaccines alone for all antigens, except for the responses to pertactin and serotype 6B pneumococcal polysaccharide. Fever was seen following 26% (158/602) to 41% (247/607) of 4CMenB doses when administered alone, compared with 23% (69/304) to 36% (109/306) after routine vaccines given alone and 51% (306/605) to 61% (380/624) after 4CMenB and routine vaccines administered together. Conclusion A 4CMenB vaccine is immunogenic against reference strains when administered with routine vaccines at 2, 4, and 6 or at 2, 3, and 4 months of age, producing minimal interference with the response to routine infant vaccinations.This publication has 21 references indexed in Scilit:
- Antibody persistence following MeNZB vaccination of adults and children and response to a fourth dose in toddlersArchives of Disease in Childhood, 2011
- Immunogenicity of Two Investigational Serogroup B Meningococcal Vaccines in the First Year of LifeThe Pediatric Infectious Disease Journal, 2010
- Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccinesProceedings of the National Academy of Sciences of the United States of America, 2010
- Safety and immunogenicity of AS03B adjuvanted split virion versus non-adjuvanted whole virion H1N1 influenza vaccine in UK children aged 6 months-12 years: open label, randomised, parallel group, multicentre studyBMJ, 2010
- Epidemiological Profile of Meningococcal Disease in the United StatesClinical Infectious Diseases, 2010
- Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidisVaccine, 2009
- Meningococcal C conjugate vaccine: The experience in England and WalesVaccine, 2009
- Global epidemiology of meningococcal diseaseVaccine, 2009
- A universal vaccine for serogroup B meningococcusProceedings of the National Academy of Sciences of the United States of America, 2006
- Interlaboratory Standardization of the Measurement of Serum Bactericidal Activity by Using Human Complement against Meningococcal Serogroup B, Strain 44/76-SL, before and after Vaccination with the Norwegian MenBvac Outer Membrane Vesicle VaccineClinical and Vaccine Immunology, 2005