TY - JOUR
T1 - Meningococcal serogroup ACWYX conjugate vaccine in Malian toddlers
AU - Tapia, Milagritos D.
AU - Sow, Samba O.
AU - Naficy, Abdi
AU - Diallo, Fatoumata
AU - Haidara, Fadima C.
AU - Chaudhari, Amol
AU - Martellet, Lionel
AU - Traore, Awa
AU - Townsend-Payne, Kelly
AU - Borrow, Raymond
AU - Hosken, Nancy
AU - Smolenov, Igor
AU - Pisal, Sambhaji S.
AU - LaForce, F. Marc
AU - Dhere, Rajeev M.
AU - Kapse, Dhananjay
AU - Tang, Yuxiao
AU - Alderson, Mark R.
AU - Kulkarni, Prasad S.
N1 - Publisher Copyright:
© 2021
PY - 2021/6/3
Y1 - 2021/6/3
N2 - BackgroundNeisseria 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.MethodsWe 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.ResultsA 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.ConclusionsNo 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, .)Meningococcal X Vaccine in MaliMeningococcal disease continues to be a major cause of illness globally. In this report from Mali, a new meningococcal vaccine, which includes a fifth serotype, X, was shown to elicit higher antibody titers than a standard meningococcal vaccine.
AB - BackgroundNeisseria 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.MethodsWe 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.ResultsA 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.ConclusionsNo 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, .)Meningococcal X Vaccine in MaliMeningococcal disease continues to be a major cause of illness globally. In this report from Mali, a new meningococcal vaccine, which includes a fifth serotype, X, was shown to elicit higher antibody titers than a standard meningococcal vaccine.
KW - AFRICAN MENINGITIS BELT
KW - IMMUNOGENICITY
KW - SURVEILLANCE
KW - SAFETY
KW - IMPACT
UR - http://www.scopus.com/inward/record.url?scp=85107447864&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2013615
DO - 10.1056/NEJMoa2013615
M3 - Article
C2 - 34077644
AN - SCOPUS:85107447864
SN - 0028-4793
VL - 384
SP - 2115
EP - 2123
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 22
ER -
