Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1–G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infants

• DOI: 10.1016/j.vaccine.2014.03.069
• Publication Date: 2014-08-02T19:37:37Z
• Authors: M.S. Dhingra; R. Kundu; M. Gupta; S. Kanungo; N. Ganguly; M.P. Singh; M.K. Bhattacharya; R. Ghosh; R. Kumar; D. Sur; S.M. Chadha; T. Saluja
• Keywords: Rotavirus vaccine

Rotavirus infections, prevalent in human populations worldwide are mostly caused by Group A viruses. Live attenuated rotavirus vaccines highly effective preventing severe gastroenteritis. However, the cost of these and local availability can be a barrier for widespread adoption public health programs developing countries where infants suffer heavy burden related morbidity mortality. phase I/II study was carried out with long term aim to produce locally licensed vaccine which is equally safe immunogenic as compared available vaccines. This conducted two cohorts. In first cohort, 20 healthy adults were administered single dose (highest antigen concentration planned infants) or placebo followed up 10 days safety. Following demonstration safety adult volunteers, 100 recruited (cohort 2) randomly divided into five equal groups. They three doses either investigational (BRV-TV) at one concentrations Rotateq Placebo 6–8, 10–12 14–16 weeks age. All till 28 after third dose. Immune response vaccine, terms seroresponse geometric mean concentrations, across Increase anti-rotavirus serum IgA antibodies from baseline, demonstrated higher immune all BRV-TV RotaTeq comparison placebo. Sero-response rates placebo, dose-levels 105.0 FFU, 105.8 106.4 post 11.1%, 27.8%, 41.2%, 83.3%, 63.2% respectively using four-fold more criteria. The arm corresponding highest FFU had sero-response rate active comparator (RotaTeq), each profile comparable treatment Overall, results showed that safe, well tolerated displayed good immunogenicity (dose–response) Indian infants.