These other studies evaluated 3 Env-derived subunit proteins and 3 canarypoxvirus (ALVAC)-vectored vaccines in Pediatric AIDS Clinical Trials Group protocols (PACTG) 320 [17], [18] and [19] and 326 [20] and [21] and HIV Pediatric Trials Network (HPTN) protocol 027 [22]. The tested ALVAC and protein

vaccines caused no increase in serious adverse events (SAE) and elicited promising immune responses similar to those observed in adults. We recently reported that the PedVacc 001 trial GSKJ4 had excellent safety and marginal immunogenicity among 20-week-old Gambian infants born to HIV-1-negative mothers [23]. Here, we report on the administration of MVA.HIVA to infants born to HIV-1-positive mothers in Kenya (PedVacc 002) with the primary aim to assess its safety. Akt inhibitor This was the first time that a rMVA vaccine with an HIV-1-derived transgene was administered to infants born to HIV-1-positive mothers. The Pediatric Vaccine (PedVacc) 002 study was a single-site, phase I/II, open, randomized, controlled trial of candidate HIV-1 vaccine MVA.HIVA compared to no treatment. The primary outcome was MVA.HIVA vaccine safety. Approvals to conduct the study were granted by the Pharmacy and Poisons Board, Ministry of Medical Services, Kenya (ref. PPB/ECCT/08/25-2/10), Kenyatta National Hospital (KNH)/University of Nairobi Research Ethics Committee (ref. P266/10/2008), Nairobi University Institutional Biosafety Committee (ref. UON/CHS/PRINC/ADM1/SC6/IBC.CTTE/13),

Oxford Tropical Research Ethics Committee (ref. OXTREC 52-08), University of Washington Institutional review Board (ref. HSD 35079), and the Stockholm Regional Ethics Committee (ref. 2009/1591-31/1). those The study was conducted according to the principles of the Declaration of Helsinki (2008) and complied with the International Conference on Harmonization Good Clinical Practice guidelines. The study was conducted at KNH in Nairobi, Kenya. HIV-1-positive pregnant women in their 2nd/3rd trimester were recruited from antenatal clinics at KNH and Nairobi City Council clinics. Women were eligible to participate if they were aged 18 years or above,

had CD4+ cell count greater than 350 μl−1, WHO stage 1 or 2 disease, planned to deliver at KNH, and planned to remain in the Nairobi area for one year after delivery. Women in the study gave written informed consent and the infant’s father, or other family member or significant person co-signed the consent form for participation. Mothers were provided with ART for PMTCT as per WHO Option B guidelines consisting of zidovudine (ZDV) or tenofovir (TDF), lamivudine (3TC), and lopinavir/ritonavir (LPV/RTV) or efavirenz (EFV) or nevirapine (NVP) during pregnancy, delivery and throughout breastfeeding. Women were counseled on feeding options and provided formula milk if they elected to use replacement feeding. Within 3 days of birth, singleton infants were enrolled if they weighed at least 2.