However, this latter regime provides no protection to young infants who have the highest incidence of disease. Our data suggest that antibody persistence after 2 doses at 24 months is similar to that following vaccination at 12 or 18 months, although the numbers in our study were small. Previous studies have reported substantial waning of bactericidal antibodies by 5 years of age after vaccination at 3 years, 27 , 28 which suggests that children receiving 2 doses of 4CMenB vaccine at 2—3 years of age might require further boosters if ongoing protection is required e.
Persistence data are needed for children aged 4—10 years through larger studies. We found that pain at the injection site was the most common local adverse event, with rates similar to those found in previous studies of 4CMenB vaccine in 3- and 5-year-old children. Therefore, there is potential for selection bias because participants who were more tolerant of the previous vaccinations may have been more likely to take part in subsequent studies.
The group sizes for participants who received priming doses at 18 and 24 months of age were small, making comparisons among follow-up groups difficult — within this limitation, there were no significant differences between the groups. Further studies would be required to explore differences between schedules in the second year of life. Two doses of 4CMenB vaccine given at 12—24 months prime the immune system against the vaccine antigens to provide a booster effect after a single dose given 2 years later.
The rates at which serum antibody titres to the different vaccine antigens wane vary widely, although the implications of this for vaccine effectiveness have not been established yet.
Children receiving their first doses at 2—3 years of age may require further booster doses if ongoing direct protection beyond 4—5 years is required, such as for those in high-risk groups, although further data in larger cohorts are required to confirm this. The authors thank all of the participants, their families and the study staff at the research centres in the participating countries for contributing to this study.
Competing interests: Manish Sadarangani has received a grant from Novartis during the conduct of this study Novartis Vaccines Division was subsequently acquired by the GSK group of companies and a grant for investigator-initiated research studies outside the submitted work from Pfizer. He has also received support for travel and accommodation to attend international conferences from GSK group of companies, and he has received support paid to his institution as a member of the advisory board for Sanofi-Pasteur MSD and as a consultant for MedImmune.
Owing to his membership on the Joint Committee on Vaccination and Immunisation for the United Kingdom Department of Health, Adam Finn no longer gives lectures or undertakes advisory work for industry, either paid or unpaid. Paul Heath has received grants paid to his institution from GSK group of companies, Sanofi-Pasteur MSD and Novartis for studies outside the submitted work, and a grant from Novartis for the submitted work.
Gianni Bona has received lecture fees and nonfinancial support for clinical trials during the conduct of this study from Novartis Vaccines and Diagnostics, and support from Novartis Vaccines and Diagnostics, GSK group of companies, Sanofi-Pasteur and Pfizer as an investigator for clinical trials outside the submitted work. Javier Diez-Domingo has received reimbursement for being a member of the advisory committees for GSK group of companies and Pfizer, as well as travel support from Pfizer.
Mildred Iro has received nonfinancial support for travel to conferences from GSK group of companies. Andrew Pollard has received a grant from Novartis during the conduct of this study, and grants from Pfizer and Okairos in the past 36 months. Daniela Toneatto declares that she is employed by and holds shares in the GSK group of companies.
All of the authors revised the manuscript critically for important intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work.
Funding: This study was sponsored by Novartis Vaccines Division. On Mar. With the lead investigators, the sponsor was involved in the design of the study, as well as analysis of the data, and review and comment on the manuscript.
Editorial control of the manuscript was assigned to the University of Oxford. The sponsor conducted the primary analysis of the data before an independent validation with full access to all data at the University of Oxford by Merryn Voysey. Data sharing: All rights and titles on the product, data and results generated during this clinical study were acquired by GSK from Novartis. The results summary for this study Legacy Novartis study no. To protect the privacy of patients and individuals involved in our studies, GSK does not publically disclose patient- level data.
Disclaimer: The views presented in this manuscript do not necessarily represent the views of the Department of Health or the Joint Committee on Vaccination and Immunisation. Read article at publisher's site DOI : JAMA , 21 , 01 Dec Hum Vaccin Immunother , 15 12 , 09 Jul Hum Vaccin Immunother , 14 8 , 21 Jun Hum Vaccin Immunother , 14 5 , 30 Apr Review Free to read. This data has been text mined from the article, or deposited into data resources.
To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation. Vaccine , 35 2 , 30 Nov Cited by: 9 articles PMID: Pediatr Infect Dis J , 35 4 :e, 01 Apr Cited by: 13 articles PMID: Carter NJ.
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Pollard AJ 1 ,. Affiliations 13 authors 1. Share this article Share with email Share with twitter Share with linkedin Share with facebook. Abstract Background One schedule for the capsular group B meningococcal vaccine 4CMenB is 2 doses that are administered 2 months apart for children aged months, with a booster dose months later.
Our objective was to provide data on persistence of human serum bactericidal antibody hSBA titres in children up to 4 years of age after initial doses at months, and immunogenicity of a booster dose at 48 months of age compared with vaccine-naive children. Methods Children previously immunized, as part of a randomized controlled trial, with 2 doses of 4CMenB vaccine at months of age received a booster at 4 years of age. Results Of children in the study, had previously received 4CMenB and were vaccine-naive controls.
Interpretation We found that waning of hSBA titres by 4 years of age occurred after 2 doses of 4CMenB vaccine administered at months, and doses at months have a priming effect on the immune system. Free full text. PMID: Author information Article notes Copyright and License information Disclaimer. Correspondence to: Matthew Snape, ku. Accepted Jun This article has been cited by other articles in PMC.
Go to:. Study participants This study was part of a larger study of which the primary outcome was persistence of hSBA titres in infants given 3 priming doses of 4CMenB vaccine as infants and a booster dose at 12, 18 or 24 months, and reported elsewhere. Many or all of the products featured here are from our partners who compensate us. This may influence which products we write about and where and how the product appears on a page.
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