| dc.description.abstract | Background:
The development of a safe and effective HIV-1
vaccine remains a global priority especially in prevention of
mother to child transmission of HIV-1 during breastfeeding.
Our vaccine platform consists of recombinant BCG prime-
recombinant modified vaccinia virus Ankara (MVA) boost. This
study is the first stage and evaluates the safety and immunoge-
nicity of MVA.HIVA, a candidate HIV-1 vaccine, among healthy
Gambian infants born to HIV 1/2 uninfected mothers.
Methods:
Sixty-five mothers were sensitized on delivery of
healthy babies at Sukuta Health Centre, The Gambia. Sixty-two of
whom consented to HIV voluntary counseling and testing and all
the mothers (100%) had negative HIV test. Forty-eight of the el-
igible infants were randomized into vaccine and no-treatment
control group at 20 weeks of age. The vaccine group received one
dose of 5
·
10^7 pfu of MVA.HIVA administered intramuscu-
larly. The safety of MVA.HIVA was determined by comparing
adverse events, reactogenicity, biochemical and haematological
data of vaccine and control groups. Immunogenicity was mea-
sured by interferon (IFN)-
c
ELISPOT assay on peripheral blood
mononuclear cells.
Results:
The mean Haemoglobin (Hb), White Blood Cell count
(WBC), Alanine transaminase (ALT) and Creatinine at pre-
vaccination and post–vaccination visits were within acceptable
normal ranges. Adverse events observed included fever, ex-
cessive crying, cough, vomiting, bilateral eye discharge, diar-
rhea and poor weight gain. All study infants had negative HIV
antibody tests at 28 weeks and no severe adverse events or
suspected unexpected serious adverse reactions were reported.
Preliminary cultured IFN-
c
ELISPOT analysis showed induc-
tion of HIV-1-specific T-cell responses in about 40% of the
vaccinees.
Conclusion:
We have shown that MVA.HIVA is safe and im-
munogenic in healthy Gambian infants. A parallel study
PedVacc002 of MVA.HIVA administered to infants born to
HIV-1-positive mothers is ongoing in Kenya. | en_US |
