drugset / Trial / NCT01881581
Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS
Phase 1
Unknown
56 enrolled
Centers for Disease Control and Prevention, China
Beijing Ditan Hospital · collabNational Institutes for Food and Drug Control, China · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA \< 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.
Timeline
- Start
- 2013-06
- Primary completion
- 2014-03
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-GPEi | Vaccine | 0.5 mg | Intramuscular |
| Subject | D-GPEi | Vaccine | 2 mg | Intramuscular |
| Subject | D-GPEi | Vaccine | 4 mg | Intramuscular |
| Subject | M-GPE | Vaccine | 3e+07 unknown | Other |
| Subject | M-GPE | Vaccine | 1e+08 unknown | Other |
| Subject | M-GPE | Vaccine | 3e+08 unknown | Other |