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NCT01378156 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART
A Phase 1 study, sponsored by GeoVax.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01378156 is a Phase 1 study that has completed, run by GeoVax. The registered enrollment target is 9 participants.
The verdict
NCT01378156, a Phase 1 study, has completed, sponsored by GeoVax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.
Interventions
- BIOLOGICAL JS7 plasmid DNA and MVA62B vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01378156
The ClinicalTrials.gov registry entry for NCT01378156 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GeoVax, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which JS7 plasmid DNA and MVA62B vaccine is the first listed.
NCT01378156 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01378156 about?
NCT01378156 is a clinical study titled "A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART". GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)D...
What is the current status of trial NCT01378156?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01378156?
The interventions under investigation include: JS7 plasmid DNA and MVA62B vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01378156?
This trial is sponsored by GeoVax, which has 4 total clinical trials registered on ClinicalTrials.gov.
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