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Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): a multicenter, open-label,
Sangeeta Yadav1, M V Manglani, Dh Ashwath Narayan
1Departments of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India; #Lokmanya Tilak Municipal Medical College and General Hospital; Mumbai, India; Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, India; Sanofi Pasteur India Pvt Ltd, Mumbai, India; and Sanofi Pasteur, Lyon, France. Correspondence to: Dr Rohit Arora, Sanofi Pasteur India Pvt Ltd, 54/A, Sir Mathuradas Vasanji Road, Andheri East, Mumbai 400 093, India. DrRohit.Arora@sanofipasteur.com.
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.
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