Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial.

Yadav, Sangeeta; Manglani, M V; Narayan, D H Ashwath; Sharma, S; Ravish, H S; Arora, R; Castells, V Bosch; Arya, S; Oster, P

Objective:

To assess the safety and immunogenicity of a quadrivalent meningococcal (groups A,C,Y,W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-DT) in India.

Design:

Open-label, descriptive, non-randomized study.

Setting:

Three medical college hospitals, one each in New Delhi, Bengaluru and Mumbai, India.

Participants:

300 healthy, vaccine-naïve participants (100 children aged 2-11 years, 100 adolescents aged 12-17 years, and 100 adults aged 18-55 years). Intervention One dose (0.5 mL) of MenACYW-DT administered intramuscularly. Main outcome

measures:

Serum bactericidal antibody titers against A, C, Y, and W were measured before and after MenACWY-DT vaccination. Safety data were also collected

Results:

Thirty days post-vaccination, geometric mean titers rose across all serogroups. Most participants had protective titers ≥8 (1/dil) across the four serogroups. The percentage (95% CI) achieving ≥8 (1/dil) in the Adolescent Group was typical – A 96.9% (91.2%; 99.4%); C 96.9% (91.2%; 99.4%); Y100% (96.3%; 100%); W100% (96.3%; 100%). In general, solicited reactions were mild and short-lived. Unsolicited events were uncommon and unrelated to vaccination.

Conclusions:

MenACYW-DT was well tolerated and elicited a robust and protective immune response 30 days post-vaccination against meningococcal serogroups A, C, Y, and W-135 in the Indian study participants aged 2-55 years.

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