Assessing the effectiveness of the Meningococcal ACWYX Conjugate Vaccine in children and young adults
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Reviewed & translated by An Duc Thien Le
Edited by Dat Tien Nguyen, B.A, ScM. |
Posted on July 5th, 2023
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Among the six serogroups of meningococcal (A, B, C, W, X, Y), serogroup A was identified as the primary cause of the majority of cases. However, thanks to the extensive vaccination program involving the MenACWY-D vaccine, the impact of serogroup A was effectively controlled and managed. Recently, the incidence rate is rising again due to other serogroups especially serogroup X as it is not included in the current four quadrivalent meningococcal conjugate MenACWY-D vaccine. Thus, a study was conducted to investigate the effectiveness and safety of novel pentavalent meningococcal ACWYX conjugate vaccine (NmCV-5).
A phase 3 clinical trial was conducted in Mali and Gambia and included 1800 participants between the age of 2 and 29 years old. The researchers assessed their seroresponse to specific serogroups. Participants were randomly assigned to be injected intramuscularly with a single dose of either vaccine NmCV-5 or vaccine MenACWY-D. The NmCV-5 formula contains 5 ug each of 5 meningococcal serogroups A, C, W, Y, X; while vaccine MenACWY-D contains 4 ug each of 4 meningococcal serogroups A, C, W and Y. After assessment at day 28 from the vaccination day, researchers find that more than 70% of participants have seroresponse with all 5 serogroups with the novel vaccine, while that of the current vaccine is only more than 50%. Therefore, the NmCV-5 vaccine demonstrated non-inferiority to MenACWY-D for serogroups A, C, W, Y and X. Although there were no notable differences in the distribution of SBA titers at baseline, the percentage of participants with results above any given titer tended to be higher after NmCV-5 vaccination than after MenACWY-D vaccination. NmCV-5 showed higher geometric mean titers (GMTs) and seroresponse rates for all serogroups and age groups compared to MenACWY-D. Moreovers, both vaccines had a similar safety profile, with mild to moderate injection-site reactions and solicited systemic adverse events that resolved with simple analgesia. The trial reported 13 pregnancies, resulting in normal deliveries or terminated pregnancies without anomalies. Overall, NmCV-5 showed promising efficacy and safety as a meningococcal vaccine.
A phase 3 clinical trial was conducted in Mali and Gambia and included 1800 participants between the age of 2 and 29 years old. The researchers assessed their seroresponse to specific serogroups. Participants were randomly assigned to be injected intramuscularly with a single dose of either vaccine NmCV-5 or vaccine MenACWY-D. The NmCV-5 formula contains 5 ug each of 5 meningococcal serogroups A, C, W, Y, X; while vaccine MenACWY-D contains 4 ug each of 4 meningococcal serogroups A, C, W and Y. After assessment at day 28 from the vaccination day, researchers find that more than 70% of participants have seroresponse with all 5 serogroups with the novel vaccine, while that of the current vaccine is only more than 50%. Therefore, the NmCV-5 vaccine demonstrated non-inferiority to MenACWY-D for serogroups A, C, W, Y and X. Although there were no notable differences in the distribution of SBA titers at baseline, the percentage of participants with results above any given titer tended to be higher after NmCV-5 vaccination than after MenACWY-D vaccination. NmCV-5 showed higher geometric mean titers (GMTs) and seroresponse rates for all serogroups and age groups compared to MenACWY-D. Moreovers, both vaccines had a similar safety profile, with mild to moderate injection-site reactions and solicited systemic adverse events that resolved with simple analgesia. The trial reported 13 pregnancies, resulting in normal deliveries or terminated pregnancies without anomalies. Overall, NmCV-5 showed promising efficacy and safety as a meningococcal vaccine.