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NCT00775424 · ClinicalTrials.gov registry record · Phase 1
PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT00775424: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT00775424 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00775424, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B). 2. To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B. Secondary objectives 1. To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay. 2. To analyze antibody responses to the vaccine antigens over time. 3. To measure CD8 cell proliferative responses to vaccine antigens over time.
Interventions
- BIOLOGICAL PENNVAX-B
- BIOLOGICAL GENEVAX IL-12-4532
- BIOLOGICAL PLACEBO
- BIOLOGICAL IL-15 adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00775424
The ClinicalTrials.gov registry entry for NCT00775424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which PENNVAX-B is the first listed.
NCT00775424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00775424 about?
NCT00775424 is a clinical study titled "PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection". A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX...
What is the current status of trial NCT00775424?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2008-09. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00775424?
The interventions under investigation include: PENNVAX-B (BIOLOGICAL), GENEVAX IL-12-4532 (BIOLOGICAL), PLACEBO (BIOLOGICAL), IL-15 adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT00775424?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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