Abstract
BackgroundA vaccine to decrease transmission of human immunodeficiency virus type 1 (HIV-1) during breast-feeding would complement efforts to eliminate infant HIV-1 infection by antiretroviral therapy. Relative to adults, infants have distinct immune development, potentially high-risk of transmission when exposed to HIV-1 and rapid progression to AIDS when infected. To date, there have been only three published HIV-1 vaccine trials in infants.Trial DesignWe conducted a randomized phase I clinical trial PedVacc 001 assessing the feasibility, safety and immunogenicity of a single dose of candidate vaccine MVA.HIVA administered intramuscularly to 20-week-old infants born to HIV-1-negative mothers in The Gambia.MethodsInfants were followed to 9 months of age with assessment of safety, immunogenicity and interference with Expanded Program on Immunization (EPI) vaccines. The trial is the first stage of developing more complex prime-boost vaccination strategies against breast milk transmission of HIV-1.ResultsFrom March to October 2010, 48 infants (24 vaccine and 24 no-treatment) were enrolled with 100% retention. The MVA.HIVA vaccine was safe with no difference in adverse events between vaccinees and untreated infants. Two vaccine recipients (9%) and no controls had positive ex vivo interferon-γ ELISPOT assay responses. Antibody levels elicited to the EPI vaccines, which included diphtheria, tetanus, whole-cell pertussis, hepatitis B virus, Haemophilus influenzae type b and oral poliovirus, reached protective levels for the vast majority and were similar between the two arms.ConclusionsA single low-dose of MVA.HIVA administered to 20-week-old infants in The Gambia was found to be safe and without interference with the induction of protective antibody levels by EPI vaccines, but did not alone induce sufficient HIV-1-specific responses. These data support the use of MVA carrying other transgenes as a boosting vector within more complex prime-boost vaccine strategies against transmission of HIV-1 and/or other infections in this age group.Trial RegistrationClinicalTrials.gov NCT00982579 The Pan African Clinical Trials Registry PACTR2008120000904116
Highlights
An unacceptably high number of children become infected with the human immunodeficiency virus type 1 (HIV-1) every year [1]
Groups were comparable by sex, age, weight and mid-upper-arm circumference (MUAC) on the day of vaccination at 20 weeks of age and comparable at baseline (19 weeks) for WBC, creatinine, alanine transaminase (ALT) and alkaline phosphatase (ALP) (Table 2)
The Pediatric Vaccine (PedVacc) 001 trial was conducted as a capacity building, feasibility and recombinant Modified vaccinia virus Ankara (MVA) safety study
Summary
An unacceptably high number of children become infected with the human immunodeficiency virus type 1 (HIV-1) every year [1]. The first African vaccine infant trial designated HIV Prevention Trials Network (HPTN) protocol 027 administered RV144 [18] ALVAC vCP1521 (expressing clade B GagProtLAI and clade E gp12092TH023 linked to the transmembrane region of gp41LAI) to infants born to HIV-1-infected mothers in Uganda [19]. All vaccines in these three trials were safe and induced immune responses broadly similar to those observed in adults [20]. This was the first time that a recombinant MVA vaccine with an HIV-1 transgene was administered to less than 1-year-old children in Africa
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