HIV Vaccine for HIV Prevention

Recruiting in Nashville (>99 mi)

+3 other 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

25 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the HIV vaccine treatment UVAX-1107, UVAX-1197?

The RV-144 trial showed a 31.2% vaccine efficacy, providing some optimism for developing an effective HIV vaccine, although the specific characteristics of a successful vaccine remain undefined. ^{1 2 3 4 5}

Is the HIV vaccine safe for humans?

The HIV vaccine, including versions like AVX101, has been tested in several trials and is generally well tolerated with no serious safety issues directly related to the vaccine. Some trials reported serious adverse events, but these were not linked to the vaccine itself, and overall, the vaccines have shown no acute or long-term serious toxicity in humans. ^{1 5 6 7 8}

How is the HIV vaccine treatment UVAX-1107 different from other HIV treatments?

UVAX-1107 is unique because it is a preventive vaccine aimed at inducing a strong immune response to prevent HIV infection, unlike existing treatments that focus on managing the virus after infection. This approach is part of ongoing research to develop vaccines that can provide partial protection by stimulating a cellular immune response. ^{1 9 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

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

I have a genetic or developed condition causing swelling attacks.

Had unexplained hives in the past year

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

First AIDS vaccine tested did not protect, but gives scientific leads. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Current advances and challenges in HIV-1 vaccines. [2019]

3. England 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. [2004]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Anticipating policy considerations for a future HIV vaccine: a preliminary study. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I safety and immunogenicity evaluations of an alphavirus replicon HIV-1 subtype C gag vaccine in healthy HIV-1-uninfected adults. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

AIDSVAX results: an important open question. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

HIV preventive vaccine research at the ANRS: the lipopeptide vaccine approach. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Current advances in HIV vaccines. [2019]

11. Brazil pubmed.ncbi.nlm.nih.gov

The human immunodeficiency virus preventive vaccine research at the French National Agency for acquired immunodeficiency syndrome research. [2019]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Recent update in HIV vaccine development. [2020]