HIV Vaccine for HIV Prevention

Not currently recruiting at 6 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Seizure medications, Immunosuppressants

Disqualifiers: Pregnancy, Diabetes, Immune deficiency, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of experimental vaccines, UVAX-1107 and UVAX-1197, aimed at preventing HIV. Researchers aim to determine the safety of these vaccines, how well participants tolerate them, and how the immune system responds. The study involves injections, blood draws, and cell checks from lymph nodes. Individuals in good health, without HIV, and able to commit to regular clinic visits over about a year might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking medications that impair immune response, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of UVAX-1107 and UVAX-1197 was tested in earlier studies. These studies found that this combination, when used with substances that boost the immune system, did not cause serious side effects. Specifically, early results from a study with healthy volunteers showed that UVAX-1107 was safe and well-tolerated.

Additionally, preclinical studies also support the safety of this combination, reporting no serious unwanted side effects.

While this current trial marks the first time this vaccine combination is tested in humans, earlier findings suggest it may be safe. However, this trial is specifically designed to further explore the safety and tolerability of these vaccines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about UVAX-1107 because it represents a potential breakthrough in HIV prevention. Unlike current treatments, which primarily focus on managing the virus with antiretroviral therapies, this vaccine aims to prevent HIV infection altogether. UVAX-1107 is unique because it uses a novel combination of immune-stimulating agents, including 3M-052-AF and Alum, to enhance the body's immune response. This approach could provide long-lasting protection against HIV, offering a significant advantage over existing treatment options that require lifelong medication adherence.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

This trial will evaluate the combination of UVAX-1107 and UVAX-1197 as a potential HIV vaccine. Research has shown that these vaccines look promising in early studies. Initial results suggest they are safe and well-tolerated by healthy volunteers. They help the immune system recognize and fight the HIV virus using tiny protein particles. This approach aims to trigger a strong immune response that could protect against HIV infection. While these results are encouraging, more research is needed to confirm their effectiveness in preventing HIV. Participants in this trial will receive different dosages and combinations of UVAX-1107 and UVAX-1197 across various treatment arms to assess their safety and efficacy. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for 25 healthy adult volunteers without HIV. Participants will be involved in the study for about a year, with clinic visits and follow-up contact after the final injection to monitor their health.

Inclusion Criteria

Have a white blood cell count within 2500 to 12,000/mm³

Be in good general health

Agree to discuss HIV risk and prevention

Exclusion Criteria

Had unexplained hives in the past year

I have a genetic or developed condition causing swelling attacks.

I have a bleeding disorder that could make medical procedures dangerous for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive UVAX-1107 and UVAX-1197 vaccines, adjuvanted with 3M-052-AF + Alum, administered at Weeks 0, 8, 20, and 32

32 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

1 follow-up contact

What Are the Treatments Tested in This Trial?

Interventions

• UVAX-1107
• UVAX-1197

Trial Overview The trial tests two HIV-1 nanoparticle vaccines, UVAX-1107 and UVAX-1197, both enhanced with an adjuvant called 3M-052-AF + Alum. It's a phase 1 trial to assess safety, comfort during administration, and immune response.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 2 Interventions

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.

Group II: Group 2 Experimental Treatment 3 Interventions

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.

Group III: Group 1 Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

Recent advancements in HIV-1 vaccine development have led to a better understanding of the virus's structure and function, resulting in innovative vaccine strategies that show promise in eliciting immune responses.

Several vaccine candidates are currently in clinical trials, with some demonstrating the ability to reduce disease severity in nonhuman primates, indicating potential effectiveness in humans, even if they do not completely prevent infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advances and challenges in HIV-1 vaccines. Rodriguez-Chavez, IR., Allen, M., Hill, EL., et al.[2019]

The V-1 Immunitor HIV vaccine was well tolerated in a study of 40 patients, showing no significant adverse effects and resulting in a mean body weight gain of 2.2 kg over 27 weeks.

The vaccine led to significant increases in CD4 and CD8 cell counts, with increases of 51 (18%) and 172 (16%) cells/mm3 respectively, suggesting potential efficacy in enhancing immune response against HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of an oral HIV vaccine (V-1 Immunitor) in AIDS patients at various stages of the disease. Jirathitikal, V., Bourinbaiar, AS.[2004]

Over 1500 healthy individuals have participated in studies of HIV-1 vaccines, which have shown good safety profiles with no serious toxicity reported, indicating that these vaccines are well tolerated.

Candidate vaccines, particularly those using gp120 and vaccinia vectors, successfully induce immune responses, including neutralizing antibodies and cytotoxic T cell activity, although they currently only neutralize laboratory-adapted HIV-1 strains, not primary isolates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human studies in the development of human immunodeficiency virus vaccines. Dolin, R.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06905275

A Clinical Trial to Evaluate the Safety and Immunogenicity ... A Clinical Trial to Evaluate the Safety and Immunogenicity of Glycan-trimmed HIV-1 Nanoparticle Vaccine (UVAX-1107), Followed by Homologous or Wild-type ...

2. eatg.org eatg.org/hiv-news/uvax-bio-announces-interim-results-from-a-phase-1-clinical-trial-evaluating-its-hiv-1-vaccine/

Uvax Bio announces interim results from a Phase 1 clinical ... The UVAX-1107 protein nanoparticle vaccine was safe and well-tolerated in healthy volunteers at the planned Interim Analysis #1.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06541093

NCT06541093 | Study to Evaluate the Safety and ... This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG ...

4. infectiousdiseases.cuimc.columbia.edu infectiousdiseases.cuimc.columbia.edu/research/clinical-trials

Clinical Trials | Infectious Diseases - Columbia University This is a first-in-human phase 1 clinical trial that will be testing 2 study vaccines, UVAX-1107 and UVAX-1197. The goal is to understand if the study products ...

5. explorationpub.com explorationpub.com/Journals/em/Article/1001364

Current treatment of HIV and prospects for cure This review provides an overview on HIV/AIDS covering a description of the disease, the mechanism of infection, HIV/AIDS symptoms, the current treatment options ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06905275

Study Details | NCT06905275 | A Clinical Trial to Evaluate ... 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 ( ...

7. synapse.patsnap.com synapse.patsnap.com/drug/5e92d0dd085c4d13a3d30cda867ae24d

UVAX-1197 - Drug Targets, Indications, Patents In a preclinical toxicology study, UVAX-1107 and UVAX-1197 combined with adjuvant was shown to be safe with no serious adverse events, consistent with ...

8. firstwordpharma.com firstwordpharma.com/story/5822887

Uvax Bio Announces Dosing of First Participant in Phase 1 ... In a preclinical toxicology study, UVAX-1107 and UVAX-1197 combined with adjuvant was shown to be safe with no serious adverse events, ...