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Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia
Fadima C Haidara1, Ama Umesi1, Samba O Sow1
1From Centre pour le Développement des Vaccins du Mali, Bamako (F.C.H., S.O.S., F.D., Y. Traore, M.F.D., M.K., A.T., M.D.T.); Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Banjul, Gambia (A.U., M.O., A.I., L.A., B.D., O.W., E.J., B.K., E.C.); the Serum Institute of India, Pune (D.K., P.S.K., A.M., S.G., P.S., A.D.S., N.A., F.M.L.); the Center for Vaccine Innovation and Access, PATH (formerly known as the Program for Appropriate Technology in Health), Seattle (M.R.A., A.N., S.L., Y. Tang, L.M., N.H., E.S., J.A.W.); and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (M.D.T.).
Insights
A new pentavalent meningococcal conjugate vaccine (NmCV-5) demonstrated non-inferiority to MenACWY-D for common serogroups and showed efficacy against serogroup X. This affordable vaccine is a promising tool for preventing meningitis in Africa.
Area of Science:
- Vaccinology
- Infectious Disease Epidemiology
- Public Health
Background:
- Effective, affordable meningococcal conjugate vaccines are crucial for controlling meningitis epidemics in Africa's meningitis belt.
- Limited data existed on the safety and immunogenicity of NmCV-5, a pentavalent vaccine targeting serogroups A, C, W, Y, and X.
Purpose of the Study:
- To assess the non-inferiority of NmCV-5 compared to MenACWY-D in terms of immunogenicity and safety.
- To evaluate the immune response to NmCV-5 in healthy young individuals in the African meningitis belt.
Main Methods:
- A Phase 3, randomized, non-inferiority trial was conducted in Mali and Gambia involving 1800 healthy participants aged 2-29 years.
- Participants received either NmCV-5 or MenACWY-D. Immunogenicity was assessed by seroresponse and geometric mean titers (GMTs) at day 28.
- Safety outcomes, including adverse events, were also monitored.
Main Results:
- NmCV-5 demonstrated non-inferior immune responses to MenACWY-D for serogroups A, C, W, and Y.
- The vaccine elicited a high seroresponse rate (97.2%) against serogroup X, meeting non-inferiority criteria.
- The incidence of systemic adverse events was similar between the NmCV-5 and MenACWY-D groups.
Conclusions:
- NmCV-5 is non-inferior to MenACWY-D for the four shared serogroups and provides immune response against serogroup X.
- The vaccine was found to be safe, with no significant safety concerns identified.
- NmCV-5 represents a potentially valuable and affordable tool for meningococcal disease prevention in the African meningitis belt.
Background:
An effective, affordable, multivalent meningococcal conjugate vaccine is needed to prevent epidemic meningitis in the African meningitis belt. Data on the safety and immunogenicity of NmCV-5, a pentavalent vaccine targeting the A, C, W, Y, and X serogroups, have been limited.
Methods:
We conducted a phase 3, noninferiority trial involving healthy 2-to-29-year-olds in Mali and Gambia. Participants were randomly assigned in a 2:1 ratio to receive a single intramuscular dose of NmCV-5 or the quadrivalent vaccine MenACWY-D. Immunogenicity was assessed at day 28. The noninferiority of NmCV-5 to MenACWY-D was assessed on the basis of the difference in the percentage of participants with a seroresponse (defined as prespecified changes in titer; margin, lower limit of the 96% confidence interval [CI] above -10 percentage points) or geometric mean titer (GMT) ratios (margin, lower limit of the 98.98% CI >0.5). Serogroup X responses in the NmCV-5 group were compared with the lowest response among the MenACWY-D serogroups. Safety was also assessed.
Results:
A total of 1800 participants received NmCV-5 or MenACWY-D. In the NmCV-5 group, the percentage of participants with a seroresponse ranged from 70.5% (95% CI, 67.8 to 73.2) for serogroup A to 98.5% (95% CI, 97.6 to 99.2) for serogroup W; the percentage with a serogroup X response was 97.2% (95% CI, 96.0 to 98.1). The overall difference between the two vaccines in seroresponse for the four shared serogroups ranged from 1.2 percentage points (96% CI, -0.3 to 3.1) for serogroup W to 20.5 percentage points (96% CI, 15.4 to 25.6) for serogroup A. The overall GMT ratios for the four shared serogroups ranged from 1.7 (98.98% CI, 1.5 to 1.9) for serogroup A to 2.8 (98.98% CI, 2.3 to 3.5) for serogroup C. The serogroup X component of the NmCV-5 vaccine generated seroresponses and GMTs that met the prespecified noninferiority criteria. The incidence of systemic adverse events was similar in the two groups (11.1% in the NmCV-5 group and 9.2% in the MenACWY-D group).
Conclusions:
For all four serotypes in common with the MenACWY-D vaccine, the NmCV-5 vaccine elicited immune responses that were noninferior to those elicited by the MenACWY-D vaccine. NmCV-5 also elicited immune responses to serogroup X. No safety concerns were evident. (Funded by the U.K. Foreign, Commonwealth, and Development Office and others; ClinicalTrials.gov number, NCT03964012.).
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