7–74.4%)
[29] and a Latin American study on Rotarix (61–65%) [30]. Our results on the 105.6 FFU/serotype formulations are in line with these studies. A large Phase III clinical trial on the 105.6 Vorinostat mw FFU/serotype formulation is now planned to achieve licensure in India as well as prequalification by WHO for global application. Given the limited knowledge on correlates of protection for rotavirus vaccine, this phase III clinical trial is designed to demonstrate that the vaccine is efficacious against rotavirus gastroenteritis. In addition, through close surveillance, the trial will greatly expand the safety database available for the product. This double blind randomized placebo controlled study will be conducted in around 7500 infants at multiple sites in India. BRV-PV or placebo will be administered in 1:1 ratio at 6, 10 and 14 weeks of age along with Universal Immunization program (UIP) vaccines. A close follow up will be maintained for rotavirus gastroenteritis cases as well as safety issues till two years of age. Immunogenicity of the vaccine will be assessed in a subset along with polio type 1, 2 and 3 antibodies. Since UIP vaccines will be given concurrently with the three doses of BRV-PV, a separate Phase III study will formally assess the potential interference of the vaccine with routine UIP immunizations. In that study, the immunogenicity of three consecutively manufactured lots will also be MEK inhibitor assessed to establish manufacturing
lot-to-lot consistency. Apart from the lyophilized presentation, SIIL is also working on a fully liquid formulation; ready-to-use vaccine which contains the reassortants of the same serotypes. Animal
toxicity studies of this formulation are anticipated to start in 2014. After technology transfer from NIAID, SIIL successfully continued the further development of the BRV-PV. The results of PDK4 the pre-clinical and clinical studies of the formulation developed at SIIL have shown that it is safe and immunogenic. The vaccine is now poised to enter the pivotal study for licensure. Eventual commercial availability of the vaccine will be important for public health programs in the developing world. The pre-clinical and clinical studies were funded by Serum Institute of India Ltd., Pune. We gratefully acknowledge the contribution of late Dr. A.Z. Kapikian; The National Institute of Allergy and Infectious Diseases (NIAID); USA, Dr. Carl Kirkwood of Murdoch Children’s Research Institute, Australia; Dr. Gagandeep Kang and Dr. Sudhir Babji of Christian Medical College, Vellore, Dr. Ashish Bavdekar; KEM Hospital Research Centre, Pune, and Dr. Sanjay Lalwani; Bharati Veedyapeeth Medical College, Pune. Conflict of interest: All study authors are employed by Serum Institute of India Ltd., Pune. “
“Rotaviruses, the primary etiological agents of severe gastroenteritis in children less than five years of age, cause more pediatric diarrhea-related deaths than any other agent in low and middle-income countries [1].