A Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type HIV-1 Nanoparticle Vaccine (UVAX-1197) Boost, Each Adjuvanted With 3M-052-AF + Alum in Adult Participants Without HIV

NCT06905275 | Suspended Phase 1 FDA Drug

• 2 other identifiers: HVTN 31939136
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase 1, first-in-human (FIH) trial for the combination of UVAX-1107 and UVAX-1197, both adjuvanted with 3M-052-AF + Aluminum Hydroxide Suspension (Alum). This means it is the first time this combination of study products is being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Twenty-five volunteers without HIV and in overall good health will be enrolled and be in this study for a little over 1 year (56 weeks) of clinic visits (about 12 visits), with a follow-up contact 1 year after the final injection to check on their health. Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (12)

• Incidence of local reactogenicity signs and symptoms

  56 weeks (collected for a minimum of 14 days following receipt of any study vaccine)

• Incidence of systemic reactogenicity signs and symptoms

  56 weeks (collected for a minimum of 14 days following receipt of any study vaccine)

• Number of participants experiencing Serious Adverse Events (SAEs) leading to early participant withdrawal or permanent discontinuation from the study

  108 weeks (throughout the study and for 52 weeks following any receipt of study product)

• Number of participants experiencing Medically Attended Adverse Events (MAAEs) leading to early participant withdrawal or permanent discontinuation from the study

  108 weeks (throughout the study and for 52 weeks following any receipt of study product)

• Number of participants experiencing Adverse Events of Special Interest (AESIs) leading to early participant withdrawal or permanent discontinuation from the study

  108 weeks (throughout the study and for 52 weeks following any receipt of study product)

• Number of participants experiencing Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation from the study

  108 weeks (throughout the study and for 52 weeks following any receipt of study product)

• Response rate of serum HIV-1 IgG binding antibodies against vaccine-matched Env antigens

  Assessed by binding antibody multiplex assay (BAMA)

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude of serum HIV-1 IgG binding antibodies against vaccine-matched Env antigens

  Assessed by BAMA

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Response rate of serum antibody (Ab) neutralization of tier 1 HIV-1 strains

  Measured by TZM-bl assay

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude of serum Ab neutralization of tier 1 HIV-1 strains

  Measured by TZM-bl assay

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains

  Measured by TZM-bl assay

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains

  Measured by TZM-bl assay

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

Secondary Outcomes (18)

• Response rate of serum HIV-1 IgG binding antibodies against heterologous Env antigens

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude of serum HIV-1 IgG binding antibodies against heterologous Env antigens

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude-breadth of serum HIV-1 IgG binding antibodies against heterologous Env antigens

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Response rate of serum Ab neutralization of heterologous HIV-1 strains

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

• Magnitude of serum Ab neutralization of heterologous HIV-1 strains

  Week 22 and Week 34 (2 weeks after the third and fourth vaccinations)

Study Arms (3)

Group 1

EXPERIMENTAL

Treatment: 150 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum, to be administered at Weeks 0 and 8. Followed by: 150 mcg of UVAX-1197 admixed with of 5 mcg of 3M-052-AF + 500 mcg Alum to be administered at Weeks 20 and 32.

Biological: 3M-052-AF + Alum; Biological: UVAX-1107; Biological: UVAX-1197

Group 2

EXPERIMENTAL

Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 0 and 8. Followed by: 300 mcg of UVAX-1197 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be administered at Weeks 20 and 32.

Biological: 3M-052-AF + Alum; Biological: UVAX-1107; Biological: UVAX-1197

Group 3

EXPERIMENTAL

Treatment: 300 mcg of UVAX-1107 admixed with 5 mcg of 3M-052-AF + 500 mcg of Alum to be at Weeks 0, 8, 20, and 32.

Biological: 3M-052-AF + Alum; Biological: UVAX-1107

Interventions

3M-052-AF + Alum BIOLOGICAL

Intramuscular (IM) injection

Group 1; Group 2; Group 3

UVAX-1107 BIOLOGICAL

IM injection

Also known as: Glycan-trimmed

Group 1; Group 2; Group 3

UVAX-1197 BIOLOGICAL

IM injection

Also known as: Wild Type (WT)

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Understand the study and agree to participate.
• Be available for follow-up visits and contact for 12 months after the last study product is administered.
• Be willing to undergo all study procedures.
• Not be in another study unless approved by both study sponsors.
• Be in good general health.
• Have normal physical exam and lab results.
• Agree to discuss HIV risk and prevention.
• Have a certain minimum hemoglobin level (≥ 11.0 g/dL for women, ≥ 13.0 g/dL for men).
• Have a white blood cell count within 2500 to 12,000/mm³.
• Have a platelet count between 125,000 to 550,000/mm³.
• Have an ALT level less than 2.5 times the upper limit of normal.
• Have a serum creatinine level within 1.1 times the normal limit.
• Have a serum calcium level of at least 8.5 mg/dL.
• Have blood pressure within specified limits.
• Test negative for HIV.

You may not qualify if:

• Breastfeeding or pregnant.
• BMI is 40 or higher (exceptions can be made if you're in good health).
• Diagnosed with diabetes (unless it's well-controlled Type 2 diabetes or gestational diabetes).
• Received an investigational HIV vaccine or monoclonal antibodies.
• Received a non-HIV investigational vaccine in the past year (exceptions exist for licensed or emergency-authorized vaccines).
• Have an immune deficiency or are taking medications that impair immune response.
• Received blood products or immunoglobulins within the last 16 weeks.
• Received certain vaccines within 4 weeks before enrollment.
• Received other vaccines within 14 days before enrollment.
• Started allergy immunotherapy within the last year (stable therapy is okay).
• Taken investigational research agents recently.
• Had a serious reaction to any vaccine.
• Have hereditary or acquired angioedema.
• Had unexplained hives in the past year.
• Have a bleeding disorder that would make study procedures risky.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• National Institutes of Health (NIH): collaborator
• Department of Health and Human Services: collaborator

Study Sites (4)

Alabama CRS (#31788)

Birmingham, Alabama, 35222, United States

Location

Columbia P&S CRS (#30329)

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Vanderbilt Vaccine (VV) CRS (#30352)

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

aluminum sulfate

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: The trial will begin with enrollment of Group 1. Groups 2 and 3 will open to enrollment concurrently. Enrollment in Group 2 and Group 3 will be randomized.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)