A Phase 1/2 Comparative Vaccine Trial of the Safety and Immunogenicity of a CRF01_AE (Subtype E) Candidate Vaccine
| Autor: | Prasert Thongcharoen, Sanjay Gurunathan, Jerome H. Kim, Victoria R. Polonis, Susan W. Barnett, Chitraporn Karnasuta, Chirasak Khamboonruang, Arthur Brown, Mark de Souza, John G. McNeil, Vinai Suriyanon, Robert Paris, Silvia Ratto-Kim, Raphaelle El Habib, Deborah L. Birx, Lynn Baglyos |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Canarypox HIV Antigens viruses HIV Infections HIV Antibodies HIV Envelope Protein gp120 Placebo HIV Envelope Protein gp160 Double-Blind Method Humans Medicine Pharmacology (medical) Lymphocytes Adverse effect Neutralizing antibody Cell Proliferation AIDS Vaccines Reactogenicity biology business.industry Immunogenicity Vaccination Vaccine trial virus diseases Middle Aged biology.organism_classification Virology Infectious Diseases Immunology biology.protein Female business Protein Binding |
| Zdroj: | JAIDS Journal of Acquired Immune Deficiency Syndromes. 46:48-55 |
| ISSN: | 1525-4135 |
| DOI: | 10.1097/qai.0b013e3181354bd7 |
| Popis: | Background The development of an effective HIV-1 vaccine is critical to control the pandemic. A prime-boost HIV-1 vaccine trial assessing safety and immunogenicity was conducted in Thailand as part of an evaluation of candidate regimens for a phase 3 efficacy trial. Methods ALVAC-HIV (vCP1521), expressing circulating recombinant form 01_AE (CRF01_AE) gp120/subtype B LAI and subtype B Gag/Protease boosted with recombinant envelope oligomeric CRF01_AE gp160 (ogp160) or bivalent CRF01_AE/subtype B gp120 CM235/SF2, was evaluated in a phase 1/II trial of 130 HIV-negative Thai adults. Results One hundred forty volunteers were enrolled, and 130 completed all safety and immunogenicity visits. Reactogenicity was common but generally mild, and there was no significant difference in the adverse event rate between vaccine and placebo recipients (P = 0.26). There were 7 serious adverse events during the follow-up period, none of which were vaccine related. Cumulative HIV-specific, CD8-mediated, cytotoxic T-lymphocyte responses were observed in 11 (25%) of 44 subjects who received ALVAC boosted by bivalent gp120 and in 5 (11%) of 45 subjects who received ALVAC boosted by ogp160, but these differences were not statistically significant compared with those in placebo recipients (P = 0.62 and P = 0.37, respectively). HIV-specific lymphoproliferative responses were detected in 84% of subunit-boosted vaccine recipients and in 10% of placebo recipients. Neutralizing antibody responses to CRF01_AE and subtype B laboratory strains were seen in 95% of ogp160-boosted and 100% of gp120 B/E-boosted vaccinees, respectively. Conclusions These 2 different prime-boost regimens seem to be safe and displayed cell-mediated immune responses consistent with those in other trials of canarypox vectors. |
| Databáze: | OpenAIRE |
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