DV700P-RNA + DV701B1.1-RNA for HIV

Recruiting at 11 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: High-dose steroids

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, Seizures, others

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

Compensation: Varies

Number of Visits: 12

Duration: 40 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new vaccines, DV700P-RNA and DV701B1.1-RNA, to evaluate their safety and the immune system's response. These vaccines are being tried in people for the first time, focusing on HIV prevention. The trial aims to determine if participants can tolerate the vaccines without excessive discomfort. Those who are HIV negative, healthy, and can commit to regular visits over approximately 16 months might be suitable candidates. Participants will undergo various procedures, such as blood tests and injections, to help researchers understand the vaccines' effects. As a Phase 1 trial, participants will be among the first to receive these new vaccines, aiding researchers in understanding their function in people.

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 impair the immune response, like high-dose steroids, you may not be eligible to participate.

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

A previous study tested the combination of DV700P-RNA and DV701B1.1-RNA vaccines in humans for the first time. As this is the initial trial involving people, information on the vaccines' effects is limited. The main goal is to determine if the vaccines are safe and tolerable without causing serious discomfort.

This phase 1 trial focuses primarily on safety. Researchers test treatments in humans for the first time during this phase, closely monitoring for any adverse side effects. Participants undergo regular check-ups, including blood tests and other procedures, to ensure their safety. While specific safety data is not yet available, this stage is crucial for identifying potential risks before progressing to larger studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional HIV treatments, which often rely on antiretroviral therapies to control the virus, DV700P-RNA and DV701B1.1-RNA offer a novel approach by using RNA-based vaccines. These treatments are designed to stimulate the body's immune response against HIV, potentially reducing the need for daily medication. Researchers are excited because this method could lead to longer-lasting protection and fewer side effects, making it a promising alternative in the fight against HIV.

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

Research has shown that RNA-based methods, such as those used in DV700P-RNA and DV701B1.1-RNA, effectively reduce HIV replication. These vaccines target the virus's genetic material, helping to stop its multiplication. Although this trial marks the first human testing of these vaccines, the approach builds on promising science. Early studies with similar RNA-based treatments have demonstrated potential in controlling HIV. This trial will evaluate the effectiveness and safety of these vaccines in the body. Participants will join one of three groups, each receiving different dosages of DV700P-RNA and DV701B1.1-RNA, to assess these treatments' effectiveness and safety. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55 without HIV. Participants will be involved in the study for approximately 16 months, attending around 12 visits involving blood draws, injections, and cell collection from lymph nodes.

Inclusion Criteria

Can attend all clinic visits until the end of the study

My hemoglobin level is at least 11.0 g/dL if female, or 13.0 g/dL if male.

Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination

Exclusion Criteria

My BMI is 40 or higher, but I am in good health.

Received other vaccines within 14 days before enrollment

I have not received blood products or immunoglobulin in the last 16 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DV700P-RNA at weeks 0, 8, and 24, followed by DV701B1.1-RNA at week 40

40 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after the final dose

24 weeks

8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• DV700P-RNA
• DV701B1.1-RNA

Trial Overview The trial is testing two new vaccines: DV700P-RNA and DV701B1.1-RNA. It's a phase 1 study to assess safety, comfort level with administration, and immune response in humans for the first time.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 2 Interventions

DV700P-RNA: 150 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 150 mcg at week 40

Group II: Group 2 Experimental Treatment 2 Interventions

DV700P-RNA: 100 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 100 mcg at week 40

Group III: Group 1 Experimental Treatment 2 Interventions

DV700P-RNA: 50 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 50 mcg at week 40

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06919016

A Study to Evaluate the Safety and Immunogenicity ... Recruiting. A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV.

2. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-type-1-hiv-1-infection-4-2025-2df04

DV700P-RNA + DV701B1.1-RNA for HIV Research shows that RNA-based strategies, like those used in DV700P-RNA and DV701B1.1-RNA, have been effective in reducing HIV replication by targeting ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-safety-and-immunogenicity-of-the-v3-region-directed-immunogens-dv700p-rna-fo

A Study to Evaluate the Safety and Immunogenicity of the V3 ... This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06919016?term=AREA%5BBasicSearch%5D(AREA%5BFunderTypeSearch%5D(NIH))&rank=3

A Study to Evaluate the Safety and Immunogenicity of the V3- ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

5. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15591.a-study-to-evaluate-the-safety-and-immunogenicity-of-the-v3-region-directed-immunogens-dv700p-rna-followed-by-dv701b1-1-rna-in-adults-without-hiv.html

Clinical Trial Details This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study ...