Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers. Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
48
1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly
Medical Research Council Laboratories, The Gambia
Banjul, Fajara, The Gambia
For safety and reactogenicity: Actively and passively collected data on adverse events
Time frame: Up to 16 weeks after vaccination
For immunity to EPI vaccines: Antibody levels to specific vaccines.
Time frame: 1 week before and 1 week after vaccination
For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides
Time frame: Up to 16 weeks after vaccination
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