RV5 Vaccine Safe, Immunogenic in HIV-Positive/HEU Infants

SAN DIEGO, CA—Attenuated live rotavirus vaccine (RV5) appears to be safe and immunogenic among HIV-positive and HIV-exposed but uninfected (HEU) infants, according to findings from the randomized, double-blind, Phase 2 IMPAACT P1072 study reported at IDWeek 2015.

RV5 was safe in the HIV-positive infants, and immunogenic in HIV-positive and HEU infants, reported study author Myron Levin, MD, FIDSA, of the University of Colorado Denver, Aurora, Colorado. Immune levels achieved after the third dose of RV5 “were not significantly different in HIV-positive compared with HEU infants,” he added.

Live rotavirus vaccines are recommended for infants; however, to date, limited information is available on their safety and immunogenicity in HIV-infected and HEU infants, Dr. Levin said.

IMPAACT P1072 studied the effects of 3 doses of live attenuated pentavalent rotavirus vaccine (RV5; n=37) or placebo (n=39) among a total of 76 HIV-positive and HEU infants at five sites in four African countries. Adverse events were recorded through 42 days after the third dose and serum was collected at study entry and 14 days after the third dose to measure G1, G2, G3, G4, and P1 serum neutralizing antibodies (SNA) and anti-rotavirus IgA levels, he reported.

There were three deaths among the HIV-positive infants, two in the placebo arm and one in the RV5 arm, which was not related to the vaccine. Of the eight hospitalizations, three were in the placebo arm; none in the RV5 arm were related to the vaccine.

HIV-positive and HEU infants who received RV5 were more likely to have a 3-fold increase in SNA G1, G4, and IgA than placebo recipients, he noted.

“Shedding of RV5 in stool was similar to that previously reported in HEU infants and was not prolonged in HIV-positive vaccinees,” Dr. Levin said. Analysis of variables that might have potentially affected antibody responses showed no consistent effect with concomitant oral polio vaccine, breastfeeding, or prevention of mother-to-child transmission prophylaxis and, among infants who were HIV-positive, there was no significant effect of CD4-positive status, viral load, or type of antiretroviral drug.

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