NCT05828095

A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV

A Phase 1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum. The primary hypothesis is that the vaccine regimen will elicit HIV-1 envelope protein-specific binding antibody (Ab) and T-cell responses

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
BIOLOGICAL	INO-6160, 2 mg	ID EP at month 0,1,3 and 6
BIOLOGICAL	Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)	IM at month 3 and 6

Timeline

• Start date: 2023-04-05
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2023-04-25
• Last updated: 2025-09-02
• Results posted: 2025-07-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study