drugset / Trial / NCT00098163
Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
Phase 1
Completed
60 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- 2009-05
Publications
- Background Cao H, Mani I, Vincent R, Mugerwa R, Mugyenyi P, Kanki P, Ellner J, Walker BD. Cellular immunity to human immunodeficiency virus type 1 (HIV-1) clades: relevance to HIV-1 vaccine trials in Uganda. J Infect Dis. 2000 Nov;182(5):1350-6. doi: 10.1086/315868. Epub 2000 Oct 9.
- Background de Bruyn G, Rossini AJ, Chiu YL, Holman D, Elizaga ML, Frey SE, Burke D, Evans TG, Corey L, Keefer MC. Safety profile of recombinant canarypox HIV vaccines. Vaccine. 2004 Jan 26;22(5-6):704-13. doi: 10.1016/j.vaccine.2003.08.023.
- Background Franchini G, Gurunathan S, Baglyos L, Plotkin S, Tartaglia J. Poxvirus-based vaccine candidates for HIV: two decades of experience with special emphasis on canarypox vectors. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S75-88. doi: 10.1586/14760584.3.4.s75.
- Background Safrit JT, Ruprecht R, Ferrantelli F, Xu W, Kitabwalla M, Van Rompay K, Marthas M, Haigwood N, Mascola JR, Luzuriaga K, Jones SA, Mathieson BJ, Newell ML; Ghent IAS Working Group on HIV in Women Children. Immunoprophylaxis to prevent mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):169-77. doi: 10.1097/00126334-200402010-00012.
- Kaleebu P, Njai HF, Wang L, Jones N, Ssewanyana I, Richardson P, Kintu K, Emel L, Musoke P, Fowler MG, Ou SS, Jackson JB, Guay L, Andrew P, Baglyos L, Cao H; HPTN 027 protocol team. Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):268-77. doi: 10.1097/01.qai.0000435600.65845.31.
- Kintu K, Andrew P, Musoke P, Richardson P, Asiimwe-Kateera B, Nakyanzi T, Wang L, Fowler MG, Emel L, Ou SS, Baglyos L, Gurunathan S, Zwerski S, Jackson JB, Guay L. Feasibility and safety of ALVAC-HIV vCP1521 vaccine in HIV-exposed infants in Uganda: results from the first HIV vaccine trial in infants in Africa. J Acquir Immune Defic Syndr. 2013 May 1;63(1):1-8. doi: 10.1097/QAI.0b013e31827f1c2d.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALVAC-HIV vCP1521 | Vaccine | 1 ml | Intramuscular |