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NCT05781542 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT05781542 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 46 participants.
The verdict
NCT05781542, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with this recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will elicit VRC01-class B-cell responses as well as antigen-specific T-cell responses.
Interventions
- BIOLOGICAL Trimer 4571
- BIOLOGICAL sD-NP-GT8 DNA
- BIOLOGICAL IL-12 DNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2023-04-10 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05781542
The ClinicalTrials.gov registry entry for NCT05781542 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trimer 4571 is the first listed.
NCT05781542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05781542 about?
NCT05781542 is a clinical study titled "Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV". This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with this recombinant DNA vaccine encoding a germline-targ...
What is the current status of trial NCT05781542?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2023-04-10. Estimated completion is 2025-04-14.
What interventions are being tested in trial NCT05781542?
The interventions under investigation include: Trimer 4571 (BIOLOGICAL), sD-NP-GT8 DNA (BIOLOGICAL), IL-12 DNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT05781542?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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