At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 55 years inclusive at enrollment
- ✓Assessed as low risk for HIV acquisition per low-risk guidelines; agrees to risk-reduction counseling and to avoid high-risk HIV exposure behaviors through final study visit
- ✓Negative HIV infection test by FDA-approved EIA or CMIA
- ✓Negative for anti-HCV antibodies or negative HCV nucleic acid test if anti-HCV positive; negative for Hepatitis B surface antigen
- ✕Previous or current recipient of an investigational HIV vaccine (prior placebo recipients not excluded)
- ✕Systemic glucocorticoid use ≥ prednisone 10 mg/day within 3 months prior to enrollment, congenital or acquired immunodeficiency, or other systemic medication likely to impair immune response
- ✕Blood products or immunoglobulin within 16 weeks prior to enrollment
- ✕Live attenuated vaccine within 4 weeks prior to enrollment (ACAM2000 for monkeypox within 30 days prior or post-enrollment or with scab still present excluded)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase-1 Open-label 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
In Brief
A Phase 1 clinical trial evaluating sD-NP-GT8 DNA, IL-12 DNA, and 3 other interventions for HIV Infections. Completed, enrolled 46 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.4 mg
1.6 mg
0.1 mg
0.4 mg
100 mcg
5 mcg
500 mcg