A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine

A randomized, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5, a new pentavalent meningococcal vaccine targeting serogroups A, C, W, X, and Y. Sixty participants randomly receiv...

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Bibliographic Details
Published in:npj vaccines 2024-08, Vol.9 (1), p.140-7, Article 140
Main Authors: Kim, Yoonjin, Bae, Sungyeun, Yu, Kyung-Sang, Lee, SeungHwan, Lee, Chankyu, Kim, Jinil, Her, Howard, Oh, Jaeseong
Format: Article
Language:English
Subjects:
692/308/153
692/699/255/1638
Biomedical and Life Sciences
Biomedicine
Epidemics
Immunogenicity
Infectious Diseases
Medical Microbiology
Meningitis
Public Health
Safety
Vaccine
Vaccines
Virology
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Summary:A randomized, active-controlled, double-blind, first-in-human, phase 1 study was conducted in healthy Korean adults to evaluate the safety, tolerability, and immunogenicity of EuNmCV-5, a new pentavalent meningococcal vaccine targeting serogroups A, C, W, X, and Y. Sixty participants randomly received a single dose of either EuNmCV-5 or MenACWY-CRM, a quadrivalent vaccine containing serogroups A, C, W, and Y. Safety was assessed through monitoring anaphylactic reactions, adverse events for 28 days, and serious adverse events over 180 days. Immunogenicity was assessed via rabbit complement-dependent serum bactericidal antibody (rSBA) assay. EuNmCV-5 was safe, well-tolerated, and elicited a substantial antibody titer increase. The seroprotection rates exceeded 96.7%, and the seroconversion rates were over 85% for all the targeted serogroups. It showed higher seroconversion rates against serogroups A and C ( p  = 0.0016 and 0.0237, respectively) and elicited a substantial increase in GMT for all targeted serogroups compared to the MenACWY-CRM. ClinicalTrials.gov identifier: NCT05739292.
ISSN:2059-0105
2059-0105
DOI:10.1038/s41541-024-00935-8