Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): A multicenter, open-label, non-randomized, phase III clinical trial

• Published in: Indian pediatrics 2014-06, Vol.51 (6), p.451-456
• Main Authors: Yadav, Sangeeta, Manglani, M. V., Ashwath Narayan, D. H., Sharma, S., Ravish, H. S., Arora, Rohit, Bosch Castells, V., Arya, S., Oster, P.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antibodies, Bacterial - blood; Child; Child, Preschool; Humans; India - epidemiology; Maternal and Child Health; Medicine; Medicine & Public Health; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Meningococcal Vaccines - immunology; Middle Aged; Pediatric Surgery; Pediatrics; Research Paper; Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology; Young Adult
• ISSN: 0019-6061; 0974-7559
• DOI: 10.1007/s13312-014-0435-7

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%); Y:100% (96.3%; 100%); W:100% (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.