PedVacc 002: a phase I/II randomized clinical trial of MVA.HIVA vaccine administered to infants born to human immunodeficiency virus type 1-positive mothers in Nairobi.
Bottom Line: A safe, effective vaccine for breastfeeding infants born to HIV-1-positive mothers could complement antiretroviral therapy (ART) for prevention of mother-to-child transmission of HIV-1.At 20 weeks of age, eligible HIV-1-negative infants were randomized to vaccine versus no-treatment arms and followed to 48 weeks of age for assessments of vaccine safety, HIV-1-specific T-cell responses and antibodies to routine childhood vaccines.Protective antibody levels were adequate and similar between arms for all routine childhood vaccines except HBV, where 71% of MVA.HIVA subjects compared to 92% of control subjects were protected (p=0.05).
Affiliation: Department of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.Show MeSH
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Mentions: Between February and November 2010, 182 mothers were screened, of whom 104 were eligible for the study. Of the 102 deliveries, 94 infants were eligible for the study, including 79 breast feeders and 15 formula feeders (Fig. 1). At 20 weeks of age, 73 infants were randomized to receive the MVA.HIVA vaccine (n = 36) or no treatment (n = 37). Mothers of randomized infants had a median age of 27 years (IQR 22-31) and were enrolled at a median gestational age of 29 weeks (IQR 24, 32). The median infant birth weight was 3.1 kg (IQR 2.95, 3.4). Seventy-one infants completed visit 10 (48 weeks) within the scheduled visit window, with one infant attending late, giving an overall retention of 99% at 48 weeks. There were no significant differences between the 2 groups at baseline (Table 1).
Affiliation: Department of Pediatrics and Child Health, University of Nairobi, PO Box 19676, 00202 Nairobi, Kenya.