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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 is a Phase 1 study that has completed, run by Steven Deeks. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03606213
The ClinicalTrials.gov registry entry for NCT03606213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Steven Deeks, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which INO-9012 is the first listed.
NCT03606213 reports 0 study locations.
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.
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