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ABSTRACT
The 4-component vaccine 4CMenB, developed against invasive disease caused by meningococcal serogroup B, is approved for use in infants in several countries worldwide. 4CMenB is mostly used as 3 + 1 schedule, except for the UK, where a 2 + 1 schedule is used, and where the vaccine showed an effectiveness of 82.9%. Here we compared the coverage of two 4CMenB vaccination schedules (3 + 1 [2.5, 3.5, 5, 11 months] versus 2 + 1 [3.5, 5, 11 months of age]) against 40 serogroup B strains, representative of epidemiologically-relevant isolates circulating in England and Wales in 2007–2008, using sera from a previous phase 3b clinical trial. The strains were tested using hSBA on pooled sera of infants, collected at one month post-primary and booster vaccination. 4CMenB coverage was defined as the percentage of strains with positive killing (hSBA titres ≥ 4 after immunisation and negative baseline hSBA titres < 2). Coverage of 4CMenB was 40.0% (95% confidence interval [CI]: 24.9–56.7) and 87.5% (95%CI: 73.2–95.8) at one month post-primary and booster vaccination, respectively, regardless of immunisation schedule. Using a more conservative threshold (post-immunisation hSBA titres ≥ 8; baseline ≤ 2), at one month post-booster dose, strain coverages were 80% (3 + 1) and 70% (2 + 1). We used a linear regression model to assess correlation between post-immunisation hSBA data for each strain in the two groups; Pearson’s correlation coefficients were 0.93 and 0.99 at one month post-primary and booster vaccination. Overall, there is no evidence for a difference in strain coverage when 4CMenB is administered according to a 3 + 1 or 2 + 1 infant vaccination schedule.
Abbreviations
| 4CMenB | = | four-component meningococcal serogroup B recombinant vaccine |
| CI | = | confidence interval |
| ELISA | = | enzyme-linked immunosorbent assay |
| hSBA | = | SBA assay with human complement |
| IMD | = | invasive meningococcal disease |
| MATS | = | Meningococcal Antigen Typing System |
| SBA | = | serum bactericidal activity |
| UK | = | United Kingdom |
Trademark
Bexsero is a trademark owned by the GSK group of companies.
Acknowledgments
The authors would like to thank the infants and children who participated in this trial, as well as their parents, the investigators, study nurses and other staff members for contributing to this study. The authors would also like to thank Alessandro Brozzi and Alessandra Anemona for statistical analysis support, and Giovanni Marino for his contribution to the study. Medical writing services were provided by Petronela M. Petrar and Sonia Norris (XPE Pharma & Science c/o GSK). Publication coordination and editorial assistance were provided by Olivier Box (XPE Pharma & Science c/o GSK).
Authors’ contribution
JAW, DT, MMG, LS, MP, AB and NG contributed to the design of the study. RB, XB, MMG, LS, MP, AB, ST and NG contributed to the collection of the data. XB, JAW, DT, AB and NG performed the study. All authors with the exception of NG were involved in the analysis and interpretation of the data.
Disclosure of potential conflicts of interest
AB, ST, LS, GM, DT, NG, MMG, EM and MP are employees of Novartis, now part of the GSK group of companies. JAW was an employee at Novartis (at the time the research was completed) and the GSK group of companies, but is currently employed at PATH. AA reports personal fees from the GSK group of companies, outside of the submitted work. RB and XB performed contract serology on behalf of Public Health England for the GSK group of companies, PATH, Pfizer and Sanofi Pasteur.
Supplemental Material
Supplemental data for this article can be accessed here.