drugset / Trial / NCT00415649
Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
Phase 2
Withdrawn
National Institute of Allergy and Infectious Diseases (NIAID)
International AIDS Vaccine Initiative · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.
Timeline
- Start
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- Primary completion
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- Completion
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Publications
- Background Barouch DH. Rational design of gene-based vaccines. J Pathol. 2006 Jan;208(2):283-9. doi: 10.1002/path.1874.
- Background Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8.
- Background Moore JP, Parren PW, Burton DR. Genetic subtypes, humoral immunity, and human immunodeficiency virus type 1 vaccine development. J Virol. 2001 Jul;75(13):5721-9. doi: 10.1128/JVI.75.13.5721-5729.2001. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VRC-HIVADV014-00-VP | Vaccine | — | — |
| Subject | VRC-HIVDNA016-00-VP | Vaccine | — | — |