Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial.
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| Title: | Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. |
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| Authors: | 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, Neal, Keith R., Okike, Ifeanyichukwu O., Morales-Aza, Begonia, Patel, Kamlesh, Snape, Matthew D., Williams, John, Gilchrist, Stefanie |
| Source: | Lancet. 12/13/2014, Vol. 384 Issue 9960, p2123-2131. 9p. 1 Diagram, 6 Charts, 1 Graph. |
| Subjects: | Meningococcal vaccines, Clinical trials, Japanese B encephalitis vaccines, Neisseria meningitidis, Public health |
| Abstract: | Background Meningococcal conjugate vaccines protect individuals directly, but can also confer herd protection by interrupting carriage transmission. We assessed the effects of meningococcal quadrivalent glycoconjugate (MenACWY-CRM) or serogroup B (4CMenB) vaccination on meningococcal carriage rates in 18-24-year-olds. Methods In this phase 3, observer-blind, randomised controlled trial, university students aged 18-24 years from ten sites in England were randomly assigned (1:1:1, block size of three) to receive two doses 1 month apart of Japanese Encephalitis vaccine (controls), 4CMenB, or one dose of MenACWY-CRM then placebo. Participants were randomised with a validated computer-generated random allocation list. Participants and outcome-assessors were masked to the treatment group. Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over 1 year. Primary outcomes were cross-sectional carriage 1 month after each vaccine course. Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination. Reactogenicity and adverse events were monitored throughout the study. Analysis was done on the modified intention-to-treat population, which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline. This trial is registered with ClinicalTrials.gov, registration number NCT01214850. Findings Between Sept 21 and Dec 21, 2010, 2954 participants were randomly assigned (987 assigned to control [984 analysed], 979 assigned to 4CMenB [974 analysed], 988 assigned to MenACWY-CRM [983 analysed]); 33% of the 4CMenB group, 34% of the MenACWY-CRM group, and 31% of the control group were positive for meningococcal carriage at study entry. By 1 month, there was no significant difference in carriage between controls and 4CMenB (odds ratio 1•2, 95% CI 0•8-1•7) or MenACWY-CRM (0•9, [0•6-1•3]) groups. From 3 months after dose two, 4CMenB vaccination resulted in significantly lower carriage of any meningococcal strain (18•2% [95% CI 3•4-30•8] carriage reduction), capsular groups BCWY (26•6% [10•5-39•9] carriage reduction), capsular groups CWY (29•6% [8•1-46•0] carriage reduction), and serogroups CWY (28•5% [2•8-47•5] carriage reduction) compared with control vaccination. Significantly lower carriage rates were also noted in the MenACWY-CRM group compared with controls: 39•0% (95% CI 17•3-55•0) carriage reduction for serogroup Y and 36•2% (15•6-51•7) carriage reduction for serogroup CWY. Study vaccines were generally well tolerated, with increased rates of transient local injection pain and myalgia in the 4CMenB group. No safety concerns were identified. Interpretation Although we detected no significant difference between groups at 1 month after vaccine course, MenACWY-CRM and 4CMenB vaccines reduced meningococcal carriage rates during 12 months after vaccination and therefore might affect transmission when widely implemented. Funding Novartis Vaccines. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 99980596 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Read%2C+Robert+C%2E%22">Read, Robert C.</searchLink><br /><searchLink fieldCode="AR" term="%22Baxter%2C+David%22">Baxter, David</searchLink><br /><searchLink fieldCode="AR" term="%22Chadwick%2C+David+R%2E%22">Chadwick, David R.</searchLink><br /><searchLink fieldCode="AR" term="%22Faust%2C+Saul+N%2E%22">Faust, Saul N.</searchLink><br /><searchLink fieldCode="AR" term="%22Finn%2C+Adam%22">Finn, Adam</searchLink><br /><searchLink fieldCode="AR" term="%22Gordon%2C+Stephen+B%2E%22">Gordon, Stephen B.</searchLink><br /><searchLink fieldCode="AR" term="%22Heath%2C+Paul+T%2E%22">Heath, Paul T.</searchLink><br /><searchLink fieldCode="AR" term="%22Lewis%2C+David+J%2E+M%2E%22">Lewis, David J. M.</searchLink><br /><searchLink fieldCode="AR" term="%22Pollard%2C+Andrew+J%2E%22">Pollard, Andrew J.</searchLink><br /><searchLink fieldCode="AR" term="%22Turner%2C+David+P%2E+J%2E%22">Turner, David P. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Bazaz%2C+Rohit%22">Bazaz, Rohit</searchLink><br /><searchLink fieldCode="AR" term="%22Ganguli%2C+Amitava%22">Ganguli, Amitava</searchLink><br /><searchLink fieldCode="AR" term="%22Havelock%2C+Tom%22">Havelock, Tom</searchLink><br /><searchLink fieldCode="AR" term="%22Neal%2C+Keith+R%2E%22">Neal, Keith R.</searchLink><br /><searchLink fieldCode="AR" term="%22Okike%2C+Ifeanyichukwu+O%2E%22">Okike, Ifeanyichukwu O.</searchLink><br /><searchLink fieldCode="AR" term="%22Morales-Aza%2C+Begonia%22">Morales-Aza, Begonia</searchLink><br /><searchLink fieldCode="AR" term="%22Patel%2C+Kamlesh%22">Patel, Kamlesh</searchLink><br /><searchLink fieldCode="AR" term="%22Snape%2C+Matthew+D%2E%22">Snape, Matthew D.</searchLink><br /><searchLink fieldCode="AR" term="%22Williams%2C+John%22">Williams, John</searchLink><br /><searchLink fieldCode="AR" term="%22Gilchrist%2C+Stefanie%22">Gilchrist, Stefanie</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 12/13/2014, Vol. 384 Issue 9960, p2123-2131. 9p. 1 Diagram, 6 Charts, 1 Graph. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Meningococcal+vaccines%22">Meningococcal vaccines</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Japanese+B+encephalitis+vaccines%22">Japanese B encephalitis vaccines</searchLink><br /><searchLink fieldCode="DE" term="%22Neisseria+meningitidis%22">Neisseria meningitidis</searchLink><br /><searchLink fieldCode="DE" term="%22Public+health%22">Public health</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Background Meningococcal conjugate vaccines protect individuals directly, but can also confer herd protection by interrupting carriage transmission. We assessed the effects of meningococcal quadrivalent glycoconjugate (MenACWY-CRM) or serogroup B (4CMenB) vaccination on meningococcal carriage rates in 18-24-year-olds. Methods In this phase 3, observer-blind, randomised controlled trial, university students aged 18-24 years from ten sites in England were randomly assigned (1:1:1, block size of three) to receive two doses 1 month apart of Japanese Encephalitis vaccine (controls), 4CMenB, or one dose of MenACWY-CRM then placebo. Participants were randomised with a validated computer-generated random allocation list. Participants and outcome-assessors were masked to the treatment group. Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over 1 year. Primary outcomes were cross-sectional carriage 1 month after each vaccine course. Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination. Reactogenicity and adverse events were monitored throughout the study. Analysis was done on the modified intention-to-treat population, which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline. This trial is registered with ClinicalTrials.gov, registration number NCT01214850. Findings Between Sept 21 and Dec 21, 2010, 2954 participants were randomly assigned (987 assigned to control [984 analysed], 979 assigned to 4CMenB [974 analysed], 988 assigned to MenACWY-CRM [983 analysed]); 33% of the 4CMenB group, 34% of the MenACWY-CRM group, and 31% of the control group were positive for meningococcal carriage at study entry. By 1 month, there was no significant difference in carriage between controls and 4CMenB (odds ratio 1•2, 95% CI 0•8-1•7) or MenACWY-CRM (0•9, [0•6-1•3]) groups. From 3 months after dose two, 4CMenB vaccination resulted in significantly lower carriage of any meningococcal strain (18•2% [95% CI 3•4-30•8] carriage reduction), capsular groups BCWY (26•6% [10•5-39•9] carriage reduction), capsular groups CWY (29•6% [8•1-46•0] carriage reduction), and serogroups CWY (28•5% [2•8-47•5] carriage reduction) compared with control vaccination. Significantly lower carriage rates were also noted in the MenACWY-CRM group compared with controls: 39•0% (95% CI 17•3-55•0) carriage reduction for serogroup Y and 36•2% (15•6-51•7) carriage reduction for serogroup CWY. Study vaccines were generally well tolerated, with increased rates of transient local injection pain and myalgia in the 4CMenB group. No safety concerns were identified. Interpretation Although we detected no significant difference between groups at 1 month after vaccine course, MenACWY-CRM and 4CMenB vaccines reduced meningococcal carriage rates during 12 months after vaccination and therefore might affect transmission when widely implemented. Funding Novartis Vaccines. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/S0140-6736(14)60842-4 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 9 StartPage: 2123 Subjects: – SubjectFull: Meningococcal vaccines Type: general – SubjectFull: Clinical trials Type: general – SubjectFull: Japanese B encephalitis vaccines Type: general – SubjectFull: Neisseria meningitidis Type: general – SubjectFull: Public health Type: general Titles: – TitleFull: Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Read, Robert C. – PersonEntity: Name: NameFull: Baxter, David – PersonEntity: Name: NameFull: Chadwick, David R. – PersonEntity: Name: NameFull: Faust, Saul N. – PersonEntity: Name: NameFull: Finn, Adam – PersonEntity: Name: NameFull: Gordon, Stephen B. – PersonEntity: Name: NameFull: Heath, Paul T. – PersonEntity: Name: NameFull: Lewis, David J. M. – PersonEntity: Name: NameFull: Pollard, Andrew J. – PersonEntity: Name: NameFull: Turner, David P. J. – PersonEntity: Name: NameFull: Bazaz, Rohit – PersonEntity: Name: NameFull: Ganguli, Amitava – PersonEntity: Name: NameFull: Havelock, Tom – PersonEntity: Name: NameFull: Neal, Keith R. – PersonEntity: Name: NameFull: Okike, Ifeanyichukwu O. – PersonEntity: Name: NameFull: Morales-Aza, Begonia – PersonEntity: Name: NameFull: Patel, Kamlesh – PersonEntity: Name: NameFull: Snape, Matthew D. – PersonEntity: Name: NameFull: Williams, John – PersonEntity: Name: NameFull: Gilchrist, Stefanie IsPartOfRelationships: – BibEntity: Dates: – D: 13 M: 12 Text: 12/13/2014 Type: published Y: 2014 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 384 – Type: issue Value: 9960 Titles: – TitleFull: Lancet Type: main |
| ResultId | 1 |
