A new article published today in the New England Journal of Medicine provides the results of a recent Phase 3 clinical trial conducted in Niger with a rotavirus vaccine candidate from India. The study, conducted by Médecins Sans Frontières (MSF) and Epicentre, evaluated the efficacy and safety of the pentavalent bovine-human reassortant rotavirus vaccine (BRV-PV) manufactured by Serum Institute of India Pvt. Ltd. in infants in Niger. Data from the trial revealed the BRV-PV to be highly efficacious for the prevention of severe rotavirus gastroenteritis and to have an excellent safety profile. In addition, the vaccine was transported and stored at ambient temperature, thus bypassing the typically challenging cold-chain requirements that apply to most other vaccines.
PATH welcomes this new data as an important contribution to inform global decision-making on the use of this vaccine in low-resource countries worldwide. Since 2011, PATH has been supporting Serum Institute's clinical development of the BRV-PV. PATH and Serum Institute are partnering in the conduct of a similar Phase 3 efficacy study of the vaccine in India with 7,500 infants at six sites. The study was recently completed and the data are under analysis.
PATH is also working with Serum Institute to conduct an additional Phase 3 study to gather data required for World Health Organization (WHO) prequalification, which would allow the vaccine to be purchased for use in developing countries worldwide. MSF's results are a valuable addition to the BRV-PV's prequalification application, as they demonstrate the vaccine's safety and efficacy in an African setting.
Diarrheal disease is a leading cause of death among children under five years of age worldwide, and rotavirus is the most common cause of severe diarrhea. In 2013, of more than half a million deaths due to diarrhea, 215,000 were due to rotavirus. Several rotavirus vaccines are already available, but they remain out of reach for many in low-resource areas. The success of this additional rotavirus vaccine candidate is an exciting and encouraging milestone towards the public health goal of improving the supply of affordable rotavirus vaccines worldwide and saving the lives of thousands of children.
PATH applauds the Serum Institute's commitment to supplying vaccines to protect low-income communities from devastating diseases. In 2002, Serum Institute joined PATH and WHO in groundbreaking work on the development and introduction of MenAfriVac® to combat meningitis A outbreaks in sub-Saharan Africa. PATH is also partnering with Serum Institute on the development of vaccines against influenza and pneumococcal disease.
The BRV-PV is a pentavalent (five-strain) vaccine constructed of bovine-human reassortant rotaviruses that match the most common human rotavirus serotypes (G1, G2, G3, G4, and G9). It is an oral vaccine administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks, along with other routine vaccinations.
The BRV strains were originally developed by the US National Institutes of Health and licensed to up to ten emerging-country manufacturers and one US company for further development. Serum Institute was one of the licensees, and they successfully developed this pentavalent version of the BRV.
Since 2006, PATH has supported the emerging-country manufacturers actively developing BRV and other vaccine candidates directly, as well as through a shared technology platform that provides a host of technologies, training, methodologies, and material. It is designed to meet common needs among the manufacturers, providing high-level expertise, minimizing cost, sharing knowledge, and ultimately accelerating the pace of development. Serum Institute has been a participant in this shared technology platform since its inception.