Safety and immunogenicity of a live attenuated pentavalent rotavirus vaccine in HIV-exposed infants with or without HIV infection in Africa
Although many HIV-infected (HIV+) and HIV-exposed but uninfected (HEU) infants have received live rotavirus vaccines since the WHO recommended universal administration of these vaccines to infants, there has been limited prospective information on their safety and immunogenicity in either group of infants.
Design/methods:
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 four African countries. Ninety-three percent 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 antirotavirus neutralizing and IgA antibodies, IgA antibody in stool, and antirotavirus memory B and T-cell FluoroSpot. Shedding of RV5 in stool was monitored.
A total of 76 HIV+ and 126 HEU infants were enrolled from 2009 to 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 antirotavirus IgA responders (at least three-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 three of five 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 five serotypes. Only one HIV+ RV5 recipient had RV5 isolated from stool.
RV5 was immunogenic in both HIV+ and HEU infants and no safety signals were observed.
Keywords: HIV exposed; HIV infection; immunogenicity; infants; rotavirus; rotavirus vaccine; safety
Document Type: Research Article
Affiliations: 1: Section of Pediatric Infectious Diseases, Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado 2: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts 3: Merck & Co, Inc., Kenilworth, New Jersey, USA 4: Section of Health Promotion, Department of Health and Environment, Municipality of Munich, Munich, Germany 5: Pfizer Inc., Collegeville, Pennsylvania 6: Division of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA 7: Department of Paediatrics and Child Health, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe 8: Formerly Harvard AIDS Institute, Gaborone, Botswana; currently Trinity Medical Centre, Port Adelaide, South Australia, Australia 9: Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia 10: Formerly Maternal Adolescent and Pediatric Research Branch, NIAID, NIH, Rockville; currently Office of AIDS Research, NIH 11: Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, Maryland 12: Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York 13: Section of Pediatric Infectious Diseases, Departments of Pediatrics, Medicine, and Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Publication date: 02 January 2017
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