RotaShield: Phase II data

Researchers at the not-for-profit International Medica Foundation reported data from a double-blind, African Phase II trial in 998 infants showing that oral RotaShield given once soon after birth and again 60 days later led to a vaccine efficacy rate of 63.1% against rotavirus gastroenteritis of any severity associated with any of the 4 serotypes in the vaccine (2% vs. 5.4%) and 60.7% against rotavirus gastroenteritis associated with any rotavirus serotype (3% vs. 7.6%) vs. placebo. RotaShield also produced a seroresponse, defined as a >=4-fold increase in serum anti-rotavirus IgA antibody titers, in 56.7% of patients after the second dose vs. 3.4% for placebo (p<0.001). The rate of adverse events was similar between treatment groups. The most common reported adverse events were malaria, respiratory tract infections, non-rotavirus-related gastroenteritis and pyrexia.

There were no reported cases of intussusception. The foundation said the data justify future studies to evaluate eliminating vaccine-associated intussusception by vaccinating earlier than the current practice with existing rotavirus vaccines. RotaShield was originally developed to be administered as 3 doses at 2, 4, and 6 months of age. Data were published in the Journal of Infectious Diseases. ...