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NCT03606213 · ClinicalTrials.gov registry record · Phase 1
Therapeutic Vaccination in Treated HIV Disease
A Phase 1 study, sponsored by Steven Deeks.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT03606213: Completed Phase 1 study, sponsored by Steven Deeks.
NCT03606213 is a Phase 1 study that has completed, run by Steven Deeks. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03606213, a Phase 1 study, has completed, sponsored by Steven Deeks.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The central premise of our program is that durable control of HIV in the absence of antiretroviral therapy ("remission") will require the generation of de novo potent and sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our program is inspired by the recent success of VGX-3100 (Inovio), a DNA therapeutic vaccine for HPV that leads to histopathologic regression of pre-malignant lesions in people and is associated with a potent, sustained boost to HPV-specific CD8+ T cell populations. A closely related multi-clade gag/pol/env DNA vaccine administered with an IL-12 DNA plasmid (PENNVAX, Inovio) has been studied for HIV prevention and is known to be both safe and highly immunogenic. In a randomized placebo-controlled study we will compare the immunogenicity and anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with IL-12). We will determine for the first time in established HIV disease whether presence of env in a DNA vaccine blunts T cell responses to more conserved Gag-specific and Pol-specific epitopes. We will also determine if Env-specific responses (which will presumably be mediated by antibodies and antibody-dependent cellular cytotoxicity, or ADCC) have a measurable effect on reservoir.
Primary Outcome
Counts and percentages of adverse events will be presented in frequency tables and characterized for each arm with 95% Clopper-Pearson Confidence Intervals. We will use the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1
Interventions
- BIOLOGICAL INO-9012
- DEVICE CELLECTRA® 2000
- BIOLOGICAL PENNVAX-GP
- BIOLOGICAL INO-6145
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2021-05-17 |
| Phase | Phase 1 |
What the finished NCT03606213 record still lists
NCT03606213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which INO-9012 is the first listed.
NCT03606213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03606213 about?
NCT03606213 is a clinical study titled "Therapeutic Vaccination in Treated HIV Disease". The central premise of our program is that durable control of HIV in the absence of antiretroviral therapy ("remission") will require the generation of de novo potent and sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our program is inspired by the recent s...
What is the current status of trial NCT03606213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2018-08-01. Estimated completion is 2021-05-17.
What interventions are being tested in trial NCT03606213?
The interventions under investigation include: INO-9012 (BIOLOGICAL), CELLECTRA® 2000 (DEVICE), PENNVAX-GP (BIOLOGICAL), INO-6145 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03606213?
This trial is sponsored by Steven Deeks, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03606213's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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