Safety and Immunogenicity of Pentavalent Rotavirus Vaccine in HIV-Infected and HIV-Exposed Infants in Africa (IMPAACT P1072)
Year: 2015
Type: article
Study design: Clinical Trial
Abstract: Background. Live rotavirus vaccines are recommended for infants worldwide regardless of potential HIV infection at birth, but information on safety and immunogenicity in HIV-infected (HIV+) and HIV-exposed uninfected (HEU) infants is limited. Methods. IMPAACT P1072, a double-blind safety and immunogenicity study, randomized infants born to HIV+ mothers to receive 3 doses of live, attenuated, pentavalent rotavirus vaccine (RV5) or placebo (P) at 5 sites in Africa. Adverse events (AE) were collected through 42 days Postdose 3 (PD3) and serum was collected at entry and 14 days PD3 to measure G1, G2, G3, G4, and P1 serum neutralizing antibodies (SNA) and anti-rotavirus IgA. Stool samples were collected to assess shedding of vaccine strain virus using a fluorescent focus assay (FFA) and RT-PCR. Proportions were compared using Fisher's exact test and antibody levels PD3 compared using censored normal regression. Results. 76 HIV + (37 RV5, 39 P, mean age 89 + 13 days); median CD4% = 29 (7–58) and 126 HEU (62 RV5, 64 P, mean age 79 + 17 days) enrolled. At dose 1, 63% had been breastfed and 75% received oral polio vaccine; 92% of HIV+ were on ART. No infants discontinued the study vaccine due to safety concerns. Three HIV+ (1 RV5, 2 P) infants died during the study of suspected pneumonia. Proportions experiencing grade >3 AE (HIV + : 14% RV5, 13% P; HEU: 2% RV5, 5% P) did not differ significantly by vaccine arm in either cohort. HIV+ and HEU infants receiving RV5 were more likely to have a 3-fold increase in SNA G1, G3, G4 and IgA than placebo recipients (all P < .001). Antibody levels PD3 in RV5 recipients did not differ significantly by HIV status. Fecal samples were positive in 7 infants (2 HIV + ; 5 HEU) for RV5 PD1 by VP6 RT-PCR; one HIV+ sample was positive by FFA. Median Baseline (BL) and PD3 Levels and % With >3-Fold Increase [×] for RV5 Recipients Conclusion. RV5 was safe in HIV+ and HEU and fecal shedding of RV5 was minimal. Statistically significantly higher immune responses to RV5 compared to placebo were demonstrated in both cohorts with no differences by HIV status in immunologic levels achieved PD3. Disclosures. M. Levin, Merck, Sharp and Dohme: Consultant and Investigator, Consulting fee and Research support. GlaxoSmithKline: Grant Investigator, Research support
Source: Open Forum Infectious Diseases
Author: Myron Levin
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
OpenAlex ID: W2263544440