drugset / Trial / NCT01371175
A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers
Phase 2
Completed
115 enrolled
International AIDS Vaccine Initiative
Medical Research Council-Oxford · collabUniversity of Nairobi · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen. Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.
Timeline
- Start
- 2003-04
- Primary completion
- 2005-05
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DNA.HIVA | Vaccine | 0.5 mg | Intramuscular |
| Subject | MVA.HIVA | Vaccine | 5e+06 unknown | Subcutaneous |
| Subject | MVA.HIVA | Vaccine | 5e+07 unknown | Subcutaneous |
| Subject | MVA.HIVA | Vaccine | 2.5e+08 unknown | Subcutaneous |