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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

Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial Thumbnail


Authors

Robert C. Read

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.

Citation

Read, R. C., Baxter, D., Chadwick, D. R., Faust, S. N., Finn, A., Gordon, S. B., …Borrow, R. (2014). Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet, 384(9960), 2123-2131. https://doi.org/10.1016/S0140-6736%2814%2960842-4

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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