Vaccine Regimen for HIV Prevention

Recruiting at 4 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Glucocorticoids, Blood products, Immunoglobulin, others

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, Seizures, 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: 31

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine approach to prevent HIV. Researchers aim to determine if a series of vaccine doses can safely enhance the body's immune response against HIV. Different groups receive varying vaccine doses to identify the most effective method. Ideal candidates for this trial are individuals in good general health who have tested negative for HIV and do not have severe asthma or other major health issues. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine approach.

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

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications that impair immune response, like glucocorticoids, or recent receipt of vaccines or investigational agents, may affect eligibility. It's best to discuss your specific medications with the trial team.

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

Research has shown that the 426c.Mod.Core-C4b vaccine, combined with an immune-boosting substance called 3M-052 AF + Alum, has been tested and found safe. In earlier studies, participants tolerated this combination well, with no major side effects reported.

However, the HxB2.WT.Core-C4b component is being tested in humans for the first time, so no previous safety data exists for it. Its inclusion in a phase 1 trial indicates confidence in its basic safety, as these trials are specifically designed to test safety and are conducted with great care.

In summary, while past studies have shown the safety of 426c.Mod.Core-C4b, the safety of HxB2.WT.Core-C4b is still under evaluation. Participants in this trial will be closely monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments 426c.Mod.Core-C4b and HxB2.WT.Core-C4b for HIV prevention because they represent a novel approach to vaccination. Unlike traditional HIV vaccines, which primarily focus on stimulating a broad immune response, these treatments aim to specifically enhance the body's ability to recognize and fight the virus by using engineered core components of the virus itself. This targeted approach could potentially offer more effective and longer-lasting protection against HIV. Additionally, the use of fractional and bolus dosing in these regimens might improve vaccine uptake and immune response, making the vaccination process more efficient and potentially reducing the number of doses needed for effective protection.

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

Research has shown that the 426c.Mod.Core-C4b vaccine, when combined with the 3M-052 AF + Alum booster, may help the body produce antibodies crucial for fighting HIV. Previous studies suggest that 426c.Mod.Core-C4b can safely trigger an immune response, making it a promising option for HIV prevention. In this trial, participants in different groups will receive varying doses of 426c.Mod.Core-C4b and HxB2.WT.Core-C4b. The new component, HxB2.WT.Core-C4b, is being tested in humans for the first time. This combination aims to further develop the B-cells initiated by the initial vaccine, strengthening the body's ability to combat HIV more effectively. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults without HIV who are in good health. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

Agrees not to enroll in another study of an investigational agent during participation in the trial. Approvals required if already enrolled in another clinical trial

My hemoglobin levels match the required levels for my gender and hormone therapy status.

White blood cell (WBC) count within specified range

Exclusion Criteria

Previous receipt of certain investigational agents

History of certain reactions or conditions

I don't have any health issues that could make treatment unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Priming

Participants receive a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum

12 weeks

Multiple visits for priming doses

Boosting

Participants receive boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum

12 weeks

Visits at 2 weeks after each boost

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at week 29, week 39, week 41, and week 51

What Are the Treatments Tested in This Trial?

Interventions

• 426c.Mod.Core-C4b
• HxB2.WT.Core-C4b

Trial Overview The study tests a new vaccine strategy against HIV/AIDS. It starts with a 'prime' shot of 426c.Mod.Core-C4b with adjuvants (substances to boost immune response) followed by 'boost' shots of HxB2.WT.Core-C4b, also with adjuvants. The goal is to see if this can improve immune defense by maturing specific antibody-producing cells.

How Is the Trial Designed?

Group I: Group 1 Active Control 5 Interventions

One fractional dose of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

Group II: Group 2A Active Control 5 Interventions

One fractional dose and one bolus dose of 426c.Mod.Core-C4b two bolus doses of HxB2.WT.Core-C4b

Group III: Group 2B Active Control 5 Interventions

One split dose and one bolus of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

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. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/569396

Clinical Trial to Evaluate the Safety and Immunogenicity of a ... This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06796686?term=HVTN&cond=HIV&aggFilters=status:rec&viewType=Table&rank=2

Study Details | NCT06796686 | Clinical Trial to Evaluate ... This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474087/

GMP Manufacturing and Characterization of the HIV Booster ... An effective vaccine is urgently needed. Germline-targeting immunogens show promise in initiating broadly neutralizing antibody (bNAb) ...

4. trial.medpath.com trial.medpath.com/clinical-trial/aa97889f6c59cb01/nct06613789-safety-immunogenicity-vaccine-infants-hiv-exposure

Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With ... This study will compare the safety and immunogenicity of an experimental HIV vaccine in infants with perinatal HIV exposure who are without HIV at birth.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06796686/clinical-trial-to-evaluate-the-safety-and-immunogenicity-of-a-priming-regimen-of-426cmodcore-c4b-followed-by-hxb2wtcore-c4b-boosts-both-adjuvanted-with-3m-052-af-alum-in-adult-participants-without-hiv-and-in-overall-good-health

Clinical Trial to Evaluate the Safety and Immunogenicity of ... This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552837/

Discovery medicine – the HVTN's iterative approach to ... The 426c.Mod.Core-C4b immunogen consists of the core inner and outer domains of the HIV-1 Clade C 426c transmitted founder viral envelope, including removal ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05471076

Study Details | NCT05471076 | Trial to Evaluate the Safety ... 1 gp140 adjuvated with 3M-052-AF + Alum is safe and well-tolerated and will further mature B-cell lineages elicited by 426c.Mod.Core-C4b priming regimens.