However, the new rotavirus vaccine, BRV-PV, has managed to overcome such an obstacle. How? BRV-PV is heat-stable, making the vaccine “the first of its kind for rotavirus prevention.”
First author on the study, Sheila Isanaka, ScD, assistant professor of nutrition at Harvard Chan School explained in the university press release
, “This trial brings a vaccine which is adapted to African settings to those who need it most.” She continued, “When the vaccine becomes widely available in Africa, it will help protect millions of the most vulnerable children.”
For the new study, the researchers conducted a randomized, placebo-controlled trial, held in Niger, one of the poorest countries in the world, with the goal of gauging the effectiveness of the new vaccine. In the trial, 3508 healthy infants received three doses of either the new vaccine, BRV-PV, or placebo at 6 weeks of age, 10 weeks of age, and finally, 14 weeks of age. The researchers noted that all the children participating in the trial “are monitored at local health centers and receive healthcare for two years.”
According the information on the trial on ClinicalTrial.gov
, the, “live attenuated bovine-human [UK] reassortant rotavirus vaccine manufactured by the Serum Institute of India, Limited (SIIL). The pentavalent vaccine (BRV-PV) contains rotavirus serotypes G1, G2, G3, G4, and G9 (≥5.6 log10 FFU/serotype/dose). The vaccine is in lyophilized form [freeze-dried] and supplied with 2.5 ml of citrate bicarbonate buffer that is added for reconstitution just before oral administration.” BRV-PV is already licensed in India; however, approval from the World Health Organization is still needed before the United Nations or government agencies can obtain it to make it available to the countries that need it most.
When speaking of potential next steps for this vaccine, Dr. Isanaka said, “After the successful clinical trial of this new vaccine, we hope that it can be made available as soon as possible to children in Niger and across Africa.”
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