RV5 Safe, Immunogenic for HIV-Exposed Infants and Infants with HIV

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The double-blind, phase 2 IMPAACT P1072 study included 76 infants who tested positive for HIV and 126 infants who had been exposed to HIV but were not infected.
The double-blind, phase 2 IMPAACT P1072 study included 76 infants who tested positive for HIV and 126 infants who had been exposed to HIV but were not infected.

Pentavalent rotavirus vaccine was found safe to use on a population of HIV-positive and HIV-exposed infants in Africa, according to research presented at IDWeek 2015.

Myron Levin, MD, FIDSA, from the University of Colorado Denver, Aurora, CO, presented research from a double-blind study that assessed the safety and immunogenicity of RV5 on infants with exposure to HIV.

The double-blind, phase 2 IMPAACT P1072 study included 76 infants who tested positive for HIV and 126 infants who had been exposed to HIV but were not infected.  Thirty-seven infants received three doses of live, attenuated, pentavalent rotavirus vaccine (RV5) and 39 infants recieved placebo vaccine at five sites in Africa.  Seventy-five percent of the infants received the oral polio vaccine, 63% were breastfed, and 92% of those who were HIV positive were on antiretroviral therapy (ART).

Patients taking RV5 were three times more likely to have an increase in serum neutralizing antibodies, G1, G3, G4, and IgA than placebo recipients. The stool samples tested positive for the vaccine strain virus in seven infants, and one sample tested positive for HIV by the fluorescent focus assay.

Overall, the data showed that there were significantly higher immune responses to RV5 when compared to the placebo, regardless of HIV infection or exposure, Dr Levin and colleagues concluded.

Reference

1. Levin M.  Safety and Immunogenicity of Pentavalent Rotavirus Vaccine in HIV-Infected and HIV-Exposed Infants in Africa (IMPAACT P1072).  Presented at: IDWeek 2015. Oct. 7-11, 2015, San Diego.

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