This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety and immunogenicity of three novel HIV vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
32
Attenuated chimp adenovirus. 5x10\^9 virus particles.
Attenuated chimp adenovirus at 5x10\^10 virus particles.
DNA at 4mg per dose.
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxon, United Kingdom
Safety
Proportion of volunteers who develop a grade 3 or 4 local reaction.
Time frame: Actively collected data throughout the study until 6 months after the last vaccination
Immunogenicity
Proportion of volunteers who develop new CD8+ and CD4+ T cell responses to one or more HIV-1 epitopes, as determined by IFN-γ ELISPOT assay.
Time frame: Samples will be collected at every visit pre- and post vaccination
Immunogenicity
Exploration of the efficacy of vaccine-induced CD8+ T cells to suppress HIV-1 replication in vitro.
Time frame: Stage 1; screen, 0, 1, 2, 4, 8, 16, 28 wk. Stage 2; screen, 0, 1, 2, 4, 8, 9, 12, 20, 28 wk. Stage 3; screen, 1, 8, 12, 13, 14, 20, 21, 22, 28 wk. Stage 4; screen, 0, 8, 12, 13, 16, 17, 18, 24, 28 wk post vac. Stage 2 & 3: 6,12,24 mth after last vaccine
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Attenuated poxvirus at 4x10\^8 plaque forming units per dose.
Phosphate buffered saline