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dc.contributor.authorTapia, Milagritos D
dc.contributor.authorSow, Samba O
dc.contributor.authorNaficy, Abdi
dc.contributor.authorDiallo, Fatoumata
dc.contributor.authorHaidara, Fadima C
dc.contributor.authorChaudhari, Amol
dc.contributor.authorMartellet, Lionel
dc.contributor.authorTraore, Awa
dc.contributor.authorTownsend-Payne, Kelly
dc.contributor.authorBorrow, Ray
dc.contributor.authorHosken, Nancy
dc.contributor.authorSmolenov, Igor
dc.contributor.authorPisal, Sambhaji S
dc.contributor.authorLaForce, F Marc
dc.contributor.authorDhere, Rajeev M
dc.contributor.authorKapse, Dhananjay
dc.contributor.authorTang, Yuxiao
dc.contributor.authorAlderson, Mark R
dc.contributor.authorKulkarni, Prasad S
dc.date.accessioned2021-06-16T14:16:19Z
dc.date.available2021-06-16T14:16:19Z
dc.date.issued2021-06-03
dc.identifier.urihttp://hdl.handle.net/10713/16026
dc.description.abstractBACKGROUND: Neisseria meningitidis serogroups A, B, C, W, X, and Y cause outbreaks of meningococcal disease. Quadrivalent conjugate vaccines targeting the A, C, W, and Y serogroups are available. A pentavalent vaccine that also includes serogroup X (NmCV-5) is under development. METHODS: We conducted a phase 2, observer-blinded, randomized, controlled trial involving Malian children 12 to 16 months of age. Participants were assigned in a 2:2:1 ratio to receive nonadjuvanted NmCV-5, alum-adjuvanted NmCV-5, or the quadrivalent vaccine MenACWY-D, administered intramuscularly in two doses 12 weeks apart. Participants were followed for safety for 169 days. Immunogenicity was assessed with an assay for serum bactericidal antibody (SBA) with rabbit complement on days 0, 28, 84, and 112. RESULTS: A total of 376 participants underwent randomization, with 150 assigned to each NmCV-5 group and 76 to the MenACWY-D group; 362 participants received both doses of vaccine. A total of 1% of the participants in the nonadjuvanted NmCV-5 group, 1% of those in the adjuvanted NmCV-5 group, and 4% of those in the MenACWY-D group reported local solicited adverse events; 6%, 5%, and 7% of the participants, respectively, reported systemic solicited adverse events. An SBA titer of at least 128 was seen in 91 to 100% (for all five serotypes) of the participants in the NmCV-5 groups and in 36 to 99% (excluding serogroup X) of those in the MenACWY-D group at day 84 (before the second dose); the same threshold was met in 99 to 100% (for all five serotypes) of the participants in the NmCV-5 groups and in 92 to 100% (excluding serogroup X) of those in the MenACWY-D group at day 112. Immune responses to the nonadjuvanted and adjuvanted NmCV-5 formulations were similar. CONCLUSIONS: No safety concerns were identified with two doses of NmCV-5. A single dose of NmCV-5 elicited immune responses that were similar to those observed with two doses of MenACWY-D. Adjuvanted NmCV-5 provided no discernible benefit over nonadjuvanted NmCV-5. (Funded by the U.K. Foreign, Commonwealth, and Development Office; ClinicalTrials.gov number, NCT03295318. opens in new tab.)en_US
dc.description.urihttps://doi.org/10.1056/NEJMoa2013615en_US
dc.language.isoenen_US
dc.publisherMassachusetts Medical Societyen_US
dc.relation.ispartofNew England Journal of Medicineen_US
dc.rightsCopyright © 2021 Massachusetts Medical Society.en_US
dc.subject.meshMeningococcal Infections--prevention & controlen_US
dc.subject.meshMeningococcal Vaccinesen_US
dc.subject.meshNeisseria Meningitidisen_US
dc.subject.meshInfanten_US
dc.subject.meshMalien_US
dc.titleMeningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlersen_US
dc.typeArticleen_US
dc.identifier.doi10.1056/NEJMoa2013615
dc.identifier.pmid34077644
dc.source.volume384
dc.source.issue22
dc.source.beginpage2115
dc.source.endpage2123
dc.source.countryUnited States


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