NCT05781542

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 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	sD-NP-GT8 DNA	0.4 mg
BIOLOGICAL	sD-NP-GT8 DNA	1.6 mg
BIOLOGICAL	IL-12 DNA	0.1 mg
BIOLOGICAL	IL-12 DNA	0.4 mg
BIOLOGICAL	Trimer 4571	100 mcg
BIOLOGICAL	3M-052-AF	5 mcg
DRUG	Alum	500 mcg

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-10-02
• Completion: 2025-04-14
• First posted: 2023-03-23
• Last updated: 2025-11-14
• Results posted: 2025-11-14

Locations

8 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study