A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults.
dc.contributor.author | Omosa-Manyonyi, G | |
dc.contributor.author | Mpendo, J | |
dc.contributor.author | Ruzagira, E | |
dc.contributor.author | Kilembe, W. | |
dc.contributor.author | Chomba, E | |
dc.contributor.author | Roman, F | |
dc.contributor.author | Bourguignon, P | |
dc.contributor.author | Koutsoukos, M | |
dc.contributor.author | Collard, A | |
dc.contributor.author | Voss, G | |
dc.contributor.author | Laufer, D | |
dc.contributor.author | Stevens, G | |
dc.contributor.author | Hayes, P | |
dc.contributor.author | Clark, L | |
dc.contributor.author | Cormier, E | |
dc.contributor.author | Dally, L | |
dc.contributor.author | Barin, B | |
dc.contributor.author | Ackland, J | |
dc.contributor.author | Syvertsen, K | |
dc.contributor.author | Zachariah, D | |
dc.contributor.author | Anas, K | |
dc.contributor.author | Sayeed, E | |
dc.contributor.author | Lombardo, A | |
dc.contributor.author | Gilmour, J | |
dc.contributor.author | Cox, J | |
dc.contributor.author | Fast, P | |
dc.contributor.author | Priddy, F | |
dc.date.accessioned | 2015-06-23T11:57:42Z | |
dc.date.available | 2015-06-23T11:57:42Z | |
dc.date.issued | 2015 | |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/pubmed/25961283 | |
dc.identifier.uri | http://hdl.handle.net/11295/85501 | |
dc.description.abstract | BACKGROUND: Sequential prime-boost or co-administration of HIV vaccine candidates based on an adjuvanted clade B p24, RT, Nef, p17 fusion protein (F4/AS01) plus a non-replicating adenovirus 35 expressing clade A Gag, RT, Int and Nef (Ad35-GRIN) may lead to a unique immune profile, inducing both strong T-cell and antibody responses. METHODS: In a phase 1, double-blind, placebo-controlled trial, 146 healthy adult volunteers were randomized to one of four regimens: heterologous prime-boost with two doses of F4/AS01E or F4/AS01B followed by Ad35-GRIN; Ad35-GRIN followed by two doses of F4/AS01B; or three co-administrations of Ad35-GRIN and F4/AS01B. T cell and antibody responses were measured. RESULTS: The vaccines were generally well-tolerated, and did not cause serious adverse events. The response rate, by IFN-γ ELISPOT, was greater when Ad35-GRIN was the priming vaccine and in the co-administration groups. F4/AS01 induced CD4+ T-cells expressing primarily CD40L and IL2 +/- TNF-α, while Ad35-GRIN induced predominantly CD8+ T-cells expressing IFN-γ +/- IL2 or TNF-α. Viral inhibition was induced after Ad35-GRIN vaccination, regardless of the regimen. Strong F4-specific antibody responses were induced. Immune responses persisted at least a year after the last vaccination. The complementary response profiles, characteristic of each vaccine, were both expressed after co-administration. CONCLUSION: Co-administration of an adjuvanted protein and an adenovirus vector showed an acceptable safety and reactogenicity profile and resulted in strong, multifunctional and complementary HIV-specific immune responses. | en_US |
dc.language.iso | en | en_US |
dc.publisher | University of Nairobi | en_US |
dc.title | A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of an Adjuvanted HIV-1 Gag-Pol-Nef Fusion Protein and Adenovirus 35 Gag-RT-Int-Nef Vaccine in Healthy HIV-Uninfected African Adults. | en_US |
dc.type | Article | en_US |
dc.type.material | en | en_US |
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