Robert C. Read
Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial
Read, Robert C.; Baxter, David; Chadwick, David R.; Faust, Saul N.; Finn, Adam; Gordon, Stephen B.; Heath, Paul T.; Lewis, David J.M.; Pollard, Andrew J.; Turner, David P.J.; Bazaz, Rohit; Ganguli, Amitava; Havelock, Tom; Neil, Keith R.; Okike, Ifeanyichukwu O; Morales-Aza, Begonia; Patel, Kamlesh; Snape, Matthew D; Williams, John; Gilchrist, Stephanie; Gray, Steve J; Maiden, Martin C J; Toneatto, Daniela; Wang, Huajun; McCarthy, Maggie; Dull, Peter M; Borrow, Ray
Authors
David Baxter
David R. Chadwick
Saul N. Faust
Adam Finn
Stephen B. Gordon
Paul T. Heath
David J.M. Lewis
Andrew J. Pollard
DAVID TURNER david.turner@nottingham.ac.uk
Clinical Associate Professor
Rohit Bazaz
Amitava Ganguli
Tom Havelock
Keith R. Neil
Ifeanyichukwu O Okike
Begonia Morales-Aza
Kamlesh Patel
Matthew D Snape
JOHN WILLIAMS john.williams7@nottingham.ac.uk
Clinical Associate Professor
Stephanie Gilchrist
Steve J Gray
Martin C J Maiden
Daniela Toneatto
Huajun Wang
Maggie McCarthy
Peter M Dull
Ray Borrow
Abstract
Background: Meningococcal conjugate vaccines protect individuals directly, but also confer herd protection by interrupting carriage transmission. This Phase III observer-blind, randomised, controlled study evaluated the effects of meningococcal quadrivalent (ACWY) glycoconjugate (MenACWY-CRM) or serogroup B (4CMenB) vaccination on meningococcal carriage rates in young adults.
Methods: University students (aged 18–24 years) from ten sites in England were randomised to receive two vaccinations one month apart: two doses of Japanese Encephalitis vaccine (controls), two doses of 4CMenB (4CMenB), or one dose of MenACWY-CRM then placebo (MenACWY-CRM). Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over one year. Primary analysis was cross-sectional carriage one month after the vaccine course; secondary analyses included comparison of carriage at any time point after primary analysis until study termination.
Findings: 2954 subjects were randomised (control, n=987; 4CMenB, n=988; MenACWY-CRM, n=979); approximately one-third of each group was positive for meningococcal carriage at study entry. By one month, there was no significant difference in carriage between controls and 4CMenB (Odds Ratios (OR) [95% CI]; 1·2 [0·8−1·7]) or MenACWY-CRM (OR [95% CI], 0·9 [0·6–1·3]) groups. From three months after dose two, 4CMenB vaccination resulted in significantly lower carriage of any meningococcal strain (calculated efficacy 18·2% [95% CI: 3·4–30·8]) and capsular groups BCWY (calculated efficacy 26·6% [95% CI: 10·5–39·9]) compared to control vaccination. Significantly lower carriage rates were also observed in the MenACWY-CRM group compared with controls: calculated efficacies 39·0% [95%CI: 17·3-55·0] and 36.2% [95%CI: 15·6-51·7] for serogroups Y and CWY, respectively.
Interpretation: MenACWY-CRM and 4CMenB vaccines reduced meningococcal carriage rates over 12 months post-vaccination and, therefore, may affect transmission where widely implemented.
Journal Article Type | Article |
---|---|
Acceptance Date | Aug 18, 2014 |
Online Publication Date | Aug 18, 2014 |
Publication Date | Dec 13, 2014 |
Deposit Date | Jun 20, 2016 |
Publicly Available Date | Jun 20, 2016 |
Journal | The Lancet |
Print ISSN | 0140-6736 |
Electronic ISSN | 1474-547X |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
Volume | 384 |
Issue | 9960 |
Pages | 2123-2131 |
DOI | https://doi.org/10.1016/S0140-6736%2814%2960842-4 |
Keywords | Meningococcal, carriage, vaccine, serogroup B, conjugate, herd protection |
Public URL | https://nottingham-repository.worktribe.com/output/740920 |
Publisher URL | https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60842-4/fulltext |
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