Vaccines for HIV Prevention

Not currently recruiting at 7 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Systemic glucocorticoids, Blood products

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, Seizure disorder, 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: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new vaccine combinations to determine if they can safely prevent HIV and help the body develop a strong immune response. Participants will receive different vaccine regimens, including the 16055 NFL Delta Gly4 Env Protein Trimer and Ad4-Env145NFL Viral Particles, to assess their safety and effectiveness in promoting B-cell and antibody development. The trial is open to adults without HIV who are in good general health, have a low likelihood of acquiring HIV, and are willing to attend regular study visits and record daily symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine combination.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that might impair your immune response, such as certain systemic medications, you may need to discuss this with the trial team.

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

Research shows that the treatments tested in this trial have been safe in earlier studies. The 16055 NFL Delta Gly4 Env protein trimer, combined with an immune response booster, has undergone safety and tolerability assessments. Although specific details from these studies are not provided here, ongoing research suggests it is reasonably safe.

For the Ad4-Env145NFL viral particles, early research indicates they are expected to be safe and should help the immune system recognize HIV. Designed as vaccine carriers, they safely introduce the virus to the immune system.

Trimer 4571 has been tested in humans before and was found to be safe and well-tolerated, with participants showing a good immune response. This past evidence supports its potential safety in the new trial.

Overall, while detailed data from these studies is not available, the treatments have been initially tested and appear safe for humans. Participants can be cautiously optimistic about their safety, but ongoing research will continue to monitor tolerability. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these HIV prevention treatments because they offer innovative approaches that differ from current options. Unlike existing HIV vaccines that mainly target specific viral proteins, these investigational treatments utilize unique protein trimer formations like the 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571, potentially offering broader protection. Additionally, the Ad4-Env145NFL treatment uses intranasal delivery, which is uncommon in current HIV prevention strategies and could enhance immune responses in mucosal areas. These novel mechanisms and delivery methods could significantly advance the fight against HIV by providing more effective and versatile vaccine options.

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

This trial will evaluate different vaccine regimens for HIV prevention. Research has shown that the 16055 NFL Delta Gly4 Env Protein Trimer, which participants in this trial may receive, is designed to maintain its shape, crucial for creating a strong immune response. Early studies indicate it works well with substances like 3M-052-AF and Alum that enhance the body's immune response, potentially helping to fight HIV.

Another treatment option in this trial involves Ad4-Env145NFL viral particles. Tests have shown these particles to be safe and capable of triggering immune responses against parts of the HIV virus in healthy volunteers, suggesting they could help boost immunity. Trimer 4571, also part of this trial, has been tested in humans and was found to be safe while generating an immune response in adults without HIV. These findings suggest that these vaccine regimens might help in developing antibodies against HIV. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults without HIV who are interested in testing new vaccine regimens aimed at preventing HIV/AIDS. Participants must attend scheduled visits and keep a daily eDiary of symptoms.

Inclusion Criteria

Platelet count within specified range

Negative for Hepatitis B surface antigen

Negative HIV test results by specified methods

Exclusion Criteria

I have had cancer within the specified timeframe.

Living with a chronic or clinically significant condition that may jeopardize safety or rights of the study participant

I have asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study vaccines as heterologous prime-boost regimens at months 0, 2, 4, 8, and 12

12 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including antibody response measurements

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 16055 NFL Delta Gly4 Env Protein Trimer
• Ad4-Env145NFL Viral Particles
• Trimer 4571

Trial Overview The study tests the safety and immune response to two experimental vaccines (16055 NFL delta Gly4 Env protein trimer and Trimer 4571) with an adjuvant, plus a viral particle booster (Ad4-Env145NFL).

How Is the Trial Designed?

Group I: Treatment 3 Experimental Treatment 3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at month 4. Ad4-Env145NFL, 5 x 108 vp to be administered IN (0.07 mL into 1 nostril) at months 8 and 12.

Group II: Treatment 2 Experimental Treatment 3 Interventions

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.27 mL each) at months 0 and 2. Ad4-Env145NFL, 5 x 108 viral particles (vp) to be administered intranasally (IN) (0.07 mL into 1 nostril) at month 4. Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate IM injections (0.2 mL each) at months 8 and 12.

Group III: Treatment 1 Experimental Treatment 1 Intervention

16055 NFL delta Gly4 trimer, 200 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as 2 separate intramuscular (IM) injections (0.27 mL each) at months 0, 2, 4, 8, and 12.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06332339/clinical-trial-to-evaluate-the-safety-tolerability-and-immunogenicity-of-16055-nfl-delta-gly4-env-protein-trimer-and-trimer-4571-combined-with-3m-052-af-alum-adjuvant-and-ad4-env145nfl-viral-particles-as-heterologous-prime-boost-regimens-in-adult-participants-without-hiv

Clinical Trial to Evaluate the Safety, Tolerability, and ... The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6056610/

Structure-Guided Redesign Improves NFL HIV Env Trimer ... We analyzed multiple new designs to explore alternative modifications, informing tertiary interactions, while maintaining NFL trimer homogeneity and integrity.

3. rsc.niaid.nih.gov rsc.niaid.nih.gov/clinical-research-sites/16055-nfl-delta-gly4-env-protein-trimer

16055 NFL Delta Gly4 Env Protein Trimer, Adjuvanted with ... 16055 NFL Delta Gly4 Env Protein Trimer, Adjuvanted with 3M-052 AF + Alum. Document Date. Tuesday, July 15, 2025.

4. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-hiv-infections-2-2024-bbcb5

Vaccines for HIV Prevention · Info for Participants Trial Overview The study tests the safety and immune response to two experimental vaccines (16055 NFL delta Gly4 Env protein trimer and Trimer 4571) with an ...

5. ctv.veeva.com ctv.veeva.com/study/clinical-trial-to-evaluate-the-safety-tolerability-and-immunogenicity-of-16055-nfl-delta-gly4-env

Clinical Trial to Evaluate the Safety, Tolerability, and ... The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06332339/

Trial | NCT06332339 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + ...