Hexavalent Vaccines in India: Current Status

ABSTRACT

Hexavalent vaccines containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, and hepatitis B virusantigens have the potential to be used for the primary series in India (6, 10, 14 weeks of age) and the toddler booster dose. Threehexavalent vaccines are available in India DTwP-Hib/HepB-IPV (wP-hexa), DTaP-IPV-HB-PRP~T(2aP-hexa), and DTaP-HBV-IPV/Hib(3aP-hexa). In the three published phase-3 Indian studies, pertussis ‘vaccine response’ rates 1 month after a 6-10-14-week primaryseries were 68.4-75.7% for wP-hexa, 93.8-99.3% for 2aP-hexa, and 97.0-100% for 3aP-hexa; seroprotection rates for the other fiveantigens were 88.2-100%, 49.6-100%, and 98.6-100%, respectively. Studies outside India show good immunogenicity/safety afterboosting dosing; immune persistence to age 4.5 years (2aP-hexa), 7-9 years (3aP-hexa) (all antigens), and 9-10 and 14-15 years,respectively (hepatitis B); and successful co-administration with other vaccines. Hexavalent vaccines could reduce the number ofinjections, simplify vaccination schedules, and improve compliance.