drugset / Trial / NCT01438606
Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.
Timeline
- Start
- 2011-10
- Primary completion
- 2013-01
- Completion
- —
Publications
- Background Rose NF, Marx PA, Luckay A, Nixon DF, Moretto WJ, Donahoe SM, Montefiori D, Roberts A, Buonocore L, Rose JK. An effective AIDS vaccine based on live attenuated vesicular stomatitis virus recombinants. Cell. 2001 Sep 7;106(5):539-49. doi: 10.1016/s0092-8674(01)00482-2.
- Background Sacha JB, Chung C, Rakasz EG, Spencer SP, Jonas AK, Bean AT, Lee W, Burwitz BJ, Stephany JJ, Loffredo JT, Allison DB, Adnan S, Hoji A, Wilson NA, Friedrich TC, Lifson JD, Yang OO, Watkins DI. Gag-specific CD8+ T lymphocytes recognize infected cells before AIDS-virus integration and viral protein expression. J Immunol. 2007 Mar 1;178(5):2746-54. doi: 10.4049/jimmunol.178.5.2746.
- Background Cooper D, Wright KJ, Calderon PC, Guo M, Nasar F, Johnson JE, Coleman JW, Lee M, Kotash C, Yurgelonis I, Natuk RJ, Hendry RM, Udem SA, Clarke DK. Attenuation of recombinant vesicular stomatitis virus-human immunodeficiency virus type 1 vaccine vectors by gene translocations and g gene truncation reduces neurovirulence and enhances immunogenicity in mice. J Virol. 2008 Jan;82(1):207-19. doi: 10.1128/JVI.01515-07. Epub 2007 Oct 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VSV-Indiana HIV gag vaccine | Vaccine | 4600 unknown | Intramuscular |
| Subject | VSV-Indiana HIV gag vaccine | Vaccine | 46000 unknown | Intramuscular |
| Subject | VSV-Indiana HIV gag vaccine | Vaccine | 480000 unknown | Intramuscular |
| Subject | VSV-Indiana HIV gag vaccine | Vaccine | 4.2e+06 unknown | Intramuscular |
| Subject | VSV-Indiana HIV gag vaccine | Vaccine | 3.4e+07 unknown | Intramuscular |