Antibodies for HIV Prevention

Recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Immunosuppressants, Seizure medications

Disqualifiers: Pregnancy, Autoimmune disease, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of three antibodies to determine if they can safely prevent HIV in adults. Participants receive these antibodies through an IV at two different times over six months. The trial seeks adults who do not have HIV, are at low risk for contracting it, and can commit to avoiding high-risk behaviors during the study. Participants must also be prepared to receive HIV test results and discuss prevention. This study aims to determine if these antibodies can provide a safe and effective method for HIV prevention. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken immunosuppressive drugs within the last 30 days, and certain other medications or treatments may also exclude you from participating. 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 antibodies VRC07-523LS and PGT121.414.LS are generally safe and well tolerated. Previous studies found that side effects were usually mild to moderate, such as minor headaches or fatigue, and not severe.

One study found that VRC07-523LS was safe at different doses and methods of administration, suggesting it could be a good option for preventing HIV. Another report confirmed that VRC07-523LS, when combined with other treatments, did not cause serious issues.

While specific details about PGDM1400LS are not provided here, its inclusion in trials with the other antibodies suggests it is also considered safe for testing. For those considering joining a trial with these antibodies, existing research supports their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these antibody treatments for HIV prevention because they offer a novel approach to blocking the virus. Unlike traditional antiretroviral therapies that need daily dosing, these antibodies, like VRC07-523LS, PGT121.414.LS, and PGDM1400LS, are administered via IV infusion only twice a year, potentially improving adherence. Moreover, these antibodies specifically target and neutralize the HIV virus, offering a targeted mechanism of action that could provide additional protection alongside existing prevention methods. This innovative approach not only simplifies the treatment regimen but also holds promise for more effective and long-lasting protection against HIV.

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

This trial will evaluate the effectiveness of the antibodies VRC07-523LS, PGT121.414.LS, and PGDM1400LS in preventing HIV. Participants will receive these antibodies in varying dosages within separate treatment groups. Studies have shown that VRC07-523LS is safe and well-tolerated, making it a strong candidate for combination treatments. Research indicates that these antibodies can neutralize different strains of the HIV virus, potentially preventing infection. Initial findings suggest that using these antibodies together could provide long-lasting protection against HIV. Overall, these antibodies represent a hopeful advancement in the effort to prevent HIV. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults without HIV. It's designed to test the safety of three different monoclonal antibodies when given through an IV. Participants should be healthy and willing to follow the study procedures for about 18 months.

Inclusion Criteria

I have taken a pregnancy test within the last 3 days and it was negative.

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

Participants must agree not to try to become pregnant through any method during the study

Exclusion Criteria

My diabetes is well-controlled Type 2 or I only had gestational diabetes.

I haven't received any human or humanized antibodies recently, except for HIV treatment over a year ago.

I haven't taken strong immune system drugs in the last month, except for minor treatments like nasal sprays or skin creams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VRC07-523LS, PGT121.414.LS, and PGDM1400LS antibodies via IV infusion at Month 0 and Month 6

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PGDM1400LS
• PGT121.414.LS
• VRC07-523LS

Trial Overview The trial is testing VRC07-523LS, PGT121.414.LS, and PGDM1400LS antibodies at various doses (400mg to 3200mg) administered intravenously. The goal is to see if they're safe and how they behave in the body over time.

How Is the Trial Designed?

Group I: Group 2 (3200 mg + 1600 mg +1600 mg) Experimental Treatment 3 Interventions

VRC07-523LS 3200mg + PGT121.414.LS 1600mg + PGDM1400LS 1600mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Group II: Group 1 (400 mg + 400 mg +400 mg) Experimental Treatment 3 Interventions

VRC07-523LS 400mg + PGT121.414.LS 400mg + PGDM1400LS 400mg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Dale and Betty Bumpers Vaccine Research Center (VRC)

Collaborator

Trials

1

Recruited

200+

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

In a study involving 107 HIV-1 infected and 82 non-infected recipients of the VRC01 antibody, higher serum concentrations of VRC01 were associated with a lower risk of HIV-1 acquisition, indicating that VRC01 concentration is a potential marker for effective dosing.

The research suggests that fixed dosing of VRC01 may be as effective as body weight-based dosing for preventing HIV-1, which could simplify future treatment regimens in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition. Seaton, KE., Huang, Y., Karuna, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06812494

NCT06812494 | A Study of VRC07-523LS, PGT121.414.LS ... Participants should be open to discussing HIV prevention. Clinic staff should assess participants as having a low risk of getting HIV, and participants must ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38260276/

A Randomised Clinical Trial of the Safety and ... - PubMed VRC07-523LS was safe and well-tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens.

3. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/drugs/vrc07-523ls/patient

VRC07-523LS Patient Drug Record | NIH Selected Study Results: Results presented at CROI 2025 showed that vesatolimod and the bNAbs VRC07-523LS and CAP256V2LS were safe, with no treatment-related ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352301824002479

Safety, tolerability, pharmacokinetics, and neutralisation ... Overall, PGT121.414.LS and VRC07-523LS were generally well tolerated, and all solicited adverse events were mild to moderate in severity. There were six grade 1 ...

5. academic.oup.com academic.oup.com/jid/article/226/3/510/6522857

Safety and Pharmacokinetics of Monoclonal Antibodies ... Overall, VRC07-523LS was found to be a suitable bnAb to take forward in developing combination bnAbs as a long-acting prevention technology to reduce HIV ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39821046/

Safety, Tolerability, and Pharmacokinetics of Long-Acting ... VRC07-523LS was well tolerated with pharmacokinetics that support further studies of potent long-acting bNAbs together with antiretrovirals to prevent HIV-1 ...

7. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004329

Safety and pharmacokinetics of VRC07-523LS administered ... VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens.