Although many HIV-infected (HIV+) and HIV-exposed but uninfected (HEU) infants have received live rotavirus vaccines since the World Health Organization recommended universal administration of these vaccines to infants, there has been limited prospective information on their safety and immunogenicity in either group of infants.
We performed a randomized, double-blinded, placebo-controlled trial of the safety and immunogenicity of oral pentavalent rotavirus vaccine (RV5) administered to HIV+ and HEU infants in 4 African countries. Ninety-three % of HIV+ infants were receiving antiretroviral therapy prior to vaccination. Participants were followed for safety. Immune responses were measured 14 days after three doses of RV5, including serum anti-rotavirus neutralizing and IgA antibodies; IgA antibody in stool; and anti-rotavirus memory B- and T-cell Fluorospot. Shedding of RV5 in stool was monitored.
76 HIV+ and 126 HEU infants were enrolled from 2009-2013. No significant differences were found in adverse event rates, including grade 3 events, between RV5 and placebo recipients, for either HIV+ or HEU infants. The proportion of anti-rotavirus IgA responders (≥3-fold increase from baseline) after RV5 administration was 81% in both HIV+ and HEU infants, which was approximately 2.5-fold higher than in placebo recipients (p < 0.001). Neutralizing antibody responses to 3 of 5 serotypes were significantly higher after RV5 regardless of HIV status, and those of HIV+ infants were equal or greater than responses of HEU infants to all 5 serotypes. Only one HIV+ RV5 recipient had RV5 isolated from stool. CONCLUSION
RV5 was immunogenic in both HIV+ and HEU infants and no safety signals were observed.