Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2-10 years: a phase II/III double-blind randomized controlled trial.
This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY(®), GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2-10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708-12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368-3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1 μg/ml, 95%CI 75.5-105.0) when compared to the PsACWY group (15.3 μg/ml, 95%CI 12.3-19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.
King Edward Memorial Hospital Research Centre, Rasta Peth, Pune, India.
Siddhivinayak
S
Hirve
Ashish
A
Bavdekar
Anand
A
Pandit
Sanjay
S
Juvekar
Malini
M
Patil
Marie-Pierre
MP
Preziosi
Yuxiao
Y
Tang
Elisa
E
Marchetti
Lionel
L
Martellet
Helen
H
Findlow
Cheryl
C
Elie
Varsha
V
Parulekar
Brian
B
Plikaytis
Ray
R
Borrow
George
G
Carlone
Prasad S
PS
Kulkarni
Akshay
A
Goel
Karupothula
K
Suresh
Suresh
S
Beri
Subhash
S
Kapre
Suresh
S
Jadhav
Jean-Marie
JM
Preaud
Simonetta
S
Viviani
F Marc
FM
LaForce
D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007194:India; D008297:Male; D008585:Meningitis, Meningococcal / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D058248:Serum Bactericidal Antibody Assay; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; C573970:MenAfriVac; C094429:Mencevax AC; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; D018074:Vaccines, Conjugate