Phase 1
Completed N=20
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
HIV-1-infection
Source: ClinicalTrials.gov NCT05828095 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness — 4; 0; 6; 7 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness |
4; 0; 6; 7; 0; 3 | — |
| PRIMARY Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration |
4; 1; 4; 5; 1; 3 | — |
| PRIMARY Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms |
4; 0; 5; 5; 1; 4 | — |
| PRIMARY Number of Participants Reporting Unsolicited Adverse Events (AEs) |
6; 6 | — |
| PRIMARY Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation |
1; 0; 0; 1; 1; 2 | — |
| PRIMARY Number of Participants With Early Study Termination and Reason for Early Study Termination |
1; 0; 0; 1; 9; 9 | — |
| PRIMARY Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination |
1; 1; 5; 9; 5; 6 | — |
| PRIMARY Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination |
72.2; 20.5; 484.6; 3564.5; 343.9; 22000 | — |
| PRIMARY Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination |
7; 7; 8; 5; 2; 2 | — |
| PRIMARY Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination |
0.05; 0.04; 0.04; 0.06; 0; 0.01 | — |
| PRIMARY Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination |
1; 0; 1; 0; 5; 3 | — |
| PRIMARY Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination |
0; 0; 0; 0; 0.06; 0.02 | — |
| SECONDARY Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations |
8.2; 5; 5; 12.7; 5; 12.8 | — |
| SECONDARY Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations |
5; 4; 3; 5; 1; 5 | — |
| SECONDARY Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay |
7; 5; 8; 9; 8; 4 | — |
| SECONDARY Epitope Specificity of HIV-1 Specific IgG Binding Ab Responses |
— | — |
| SECONDARY Response Rate of CD4 +T-cell Responses |
— | — |
| SECONDARY Magnitude of CD4 +T-cell Responses |
— | — |
| SECONDARY Response Rate of CD8+T-cell Responses |
— | — |
| SECONDARY Magnitude of CD8+T-cell Responses |
— | — |
| SECONDARY Magnitude of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools |
— | — |
| SECONDARY Response Rate of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools |
— | — |
| SECONDARY Magnitude of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools |
— | — |
| SECONDARY Response Rate of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools |
— | — |
| SECONDARY Response Rate of HIV-1 Specific IgG Binding Ab Response |
— | — |
| SECONDARY Magnitude of HIV-1 Specific IgG Binding Ab Response |
— | — |
| SECONDARY Neutralizing Ab Magnitude and Breadth Against Autologous Tier 2 HIV-1 Isolates |
— | — |
Eligibility Criteria
Inclusion Criteria
- Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly
- 18-55 years old, inclusive, on day of enrollment
- Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last vaccine administration
- Agrees not to enroll in another study of an investigational agent during participation in the trial
- In good general health according to the clinical judgment of the site investigator
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator
- Assessed as low risk for HIV acquisition per low risk guidelines, agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking PrEP as prescribed for 6 months or longer
- Hemoglobin:
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
- ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender men who have been on hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months
- For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on their sex assigned at birth
- White blood cell (WBC) count = 2,500-12,000/mm3 (not exclusionary: if count greater than 12,000 with investigation showing general good health and PSRT approval)
- Platelets = 125,000-550,000/mm3
- Alanine aminotransferase (ALT) 2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment
- Investigator concern for difficulty with venous access based upon clinical history and physical examination. For example, history of IV drug abuse or substantial difficulty with previous blood draws.
- Presence of implanted electronic medical device (eg, pacemaker, implantable cardioverter defibrillator)
- Presence of surgical or traumatic metal implant in either upper arm and/or upper torso
- History of cardiac arrhythmia (eg, supraventricular tachycardia, atrial fibrillation) (Not excluded: sinus arrhythmia)
- Tattoo overlying the injection sites preventing assessment of reactogenicity in the view of the investigator or skin condition at the injection sites
- History or presence of keloid scar formation or hypertrophic scar
Data sourced from ClinicalTrials.gov (NCT05828095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.