SUSPENDED

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 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

Quick Facts

Study Start:2025-07-07

Study Completion:2027-07-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06905275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Test negative for Hepatitis C. * Test negative for Hepatitis B. * Women who can become pregnant must use effective contraception and test negative for pregnancy at enrollment. * Women who can become pregnant must agree not to seek pregnancy through alternative methods during the study period.	* 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. * Had seizures or taken seizure medication in the past 3 years. * Spleen has been removed or spleen doesn't work properly. * Active duty or reserve US military personnel. * Any serious health condition that could affect safety, rights, or ability to participate (including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential recurrence). * Asthma that requires frequent or high-dose medication, emergency care, or multiple maintenance therapies. * History of certain immune-mediated medical conditions (mild, localized conditions may be okay). * Allergic to local anesthetics like Novocaine or Lidocaine. * History of difficult venous access or intravenous drug use.

Inclusion Criteria

Exclusion Criteria

* 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.
* Test negative for Hepatitis C.
* Test negative for Hepatitis B.
* Women who can become pregnant must use effective contraception and test negative for pregnancy at enrollment.
* Women who can become pregnant must agree not to seek pregnancy through alternative methods during the study period.

* 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.
* Had seizures or taken seizure medication in the past 3 years.
* Spleen has been removed or spleen doesn't work properly.
* Active duty or reserve US military personnel.
* Any serious health condition that could affect safety, rights, or ability to participate (including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential recurrence).
* Asthma that requires frequent or high-dose medication, emergency care, or multiple maintenance therapies.
* History of certain immune-mediated medical conditions (mild, localized conditions may be okay).
* Allergic to local anesthetics like Novocaine or Lidocaine.
* History of difficult venous access or intravenous drug use.

Contacts and Locations

Study Locations (Sites)

Alabama CRS (#31788)

Birmingham, Alabama, 35222

United States

Columbia P&S CRS (#30329)

New York, New York, 10032

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

Vanderbilt Vaccine (VV) CRS (#30352)

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07

Study Completion Date2027-07-20

Study Record Updates

Study Start Date2025-07-07

Study Completion Date2027-07-20

Terms related to this study

Additional Relevant MeSH Terms

HIV-1-infection