At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
INO-6160, 2 mg +1 morebiological
Likely dose
INO-6160, 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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 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
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 25, 2023·Updated Sep 2, 2025
In Brief
A Phase 1 clinical trial evaluating INO-6160, 2 mg and Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) for HIV-1-infection. Completed, enrolled 20 participants across 3 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1-infection
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartApr 2023
First PostedApr 2023
Primary CompletionJan 2025
TodayJul 2026
First PostedApr 25, 2023
Enrollment StartApr 5, 2023
Primary CompletionJan 23, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.2 years ago
Interventions
INO-6160, 2 mgbiological
ID EP at month 0,1,3 and 6
Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)biological
IM at month 3 and 6