A Randomised, Placebo-Controlled, Double-Blind, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic pHIS-HIV-AE DNA Prime and rFPV-HIV-AE Boost HIV Vaccination Strategy

The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research. Various approaches are being investigated in monkey models and humans. This is a randomized, double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus (HIV) vaccine strategy in 24 healthy adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection. Volunteers will receive three "priming" vaccinations at weeks 0, 4 and 8 (pHIS-HIV-AE, a DNA vector delivering AE clade HIV-1 genes). This will be followed at week 12 by single "boost" vaccination (rFPV-HIV-AE, non-replicating, recombinant fowlpox virus vector delivering the same HIV-1 genes). Safety and immunological monitoring will continue to 52 weeks

开始日期2007-08-01

申办/合作机构

Kirby Institute

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100 项与 pHIS-HIV-AE (DNA vaccine) prime(Kirby Institute) 相关的临床结果

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100 项与 pHIS-HIV-AE (DNA vaccine) prime(Kirby Institute) 相关的转化医学

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100 项与 pHIS-HIV-AE (DNA vaccine) prime(Kirby Institute) 相关的专利（医药）

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项与 pHIS-HIV-AE (DNA vaccine) prime(Kirby Institute) 相关的文献（医药）

2010-10-01·Human Vaccines

An HIV-1 clade A/E DNA prime, recombinant fowlpox virus boost vaccine is safe, but non-immunogenic in a randomized phase I/IIa trial in Thai volunteers at low risk of HIV infection

Article

作者: Sasiwimol Ubolyam ; David A Cooper ; Praphan Phanuphak ; Sean Emery ; Sunee Sirivichayakul ; Anthony Kelleher ; Rebekah L Puls ; Kiat Ruxrungtham ; Stephen Kerr ; Atchriya Hemachandra ; Pattarawat Thantiworasit

BACKGROUNDPreviously demonstrated safe and highly immunogenic in non-human primates, this study assessed DNA (pHIS-HIV-AE) prime, recombinant fowlpox (rFPV-HIV-AE) boost vaccines in humans.RESULTSEight participants (6 active vaccine, 2 placebo) received all vaccinations; local and systemic reactions were mild to moderate. The percentage CD4(+) and CD8(+) T cells responding to HIV-1 Gag antigens by ICS (mean ± SD) was 0.16 ± 0.12 and 0.10 ± 0.12 for active and 0.01 ± 0.01 and 0.00 ± 0.00 for placebo vaccine respectively. The percentage of T cells responding did not reach pre-defined thresholds to be considered positive responses. Consequently, the Data Safety Monitoring Board recommended cessation of further recruitment. Existing volunteers were followed to 52 weeks.METHODSVectors expressing homologous HIV-1 clade A/E gag, pol, env and regulatory genes or matched placebo were administered intramuscularly at weeks 0, 4, 8 (6 mg pHIS-HIV-AE) and week 12 (3.0 x 10(8) pfu rFPV-HIV-AE) in this randomized, double-blind, placebo-controlled phase I/IIa study in healthy Thai adults at low risk of HIV infection. Immunogenicity was determined by interferon-gamma and IL-2 expression using intracellular cytokine staining assay (ICS), 13 weeks after randomization. Interim analysis was performed when eight volunteers reached 16 weeks follow-up.CONCLUSIONSVaccine candidates were generally well tolerated, but showed limited immunogenicity. Better vaccines and delivery systems are required.

100 项与 pHIS-HIV-AE (DNA vaccine) prime(Kirby Institute) 相关的药物交易

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