DV201P-RNA + DV202B1-RNA for HIV Prevention

Not yet recruiting at 6 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing two new experimental HIV vaccines, DV201P-RNA and DV202B1-RNA, to assess their safety and ability to help the body build protection against HIV. Different groups will receive varying doses of these vaccines to determine the optimal and safest amount. Participants who are generally healthy, do not have HIV, and have not previously received an HIV vaccine may be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive these new vaccines.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that might impair immune response, like certain steroids, or if you have received certain vaccines recently, you might need to discuss this with the trial team.

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

Research has shown that the combination of DV201P-RNA and DV202B1-RNA vaccines is just beginning to be tested in humans. These vaccines aim to help the body produce specific antibodies against HIV. This trial marks the first use of these vaccines in humans, focusing on their safety and the body's response.

As a Phase 1 trial, the primary goal is to determine the vaccines' safety in humans. This stage involves a small group of healthy volunteers. Detailed safety information from other studies is not yet available. However, the trial's progression suggests that earlier lab and animal studies demonstrated promising safety results.

Participants will receive varying doses to identify the safest amount. This approach helps ensure that any potential side effects, such as mild reactions at the injection site or temporary flu-like symptoms, remain manageable. Overall, the trial aims to confirm that the vaccines are well-tolerated before advancing to larger studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about DV201P-RNA and DV202B1-RNA for HIV prevention because they use a cutting-edge RNA-based approach, which is different from the standard antiretroviral therapies that target the virus after infection. These treatments aim to prevent the virus from taking hold in the first place. Unlike traditional therapies that require daily medication, this experimental approach involves periodic doses, potentially making it easier for patients to adhere to the regimen. Additionally, the RNA-based mechanism might offer a new way to block HIV, which could complement existing preventive strategies.

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

Research shows that DV201P-RNA and DV202B1-RNA could effectively prevent HIV. In this trial, participants will receive different dosages of these treatments, which help the body produce antibodies to find and block the virus. These treatments use mRNA technology, instructing cells to make a protein that triggers an immune response against HIV. Similar technologies have successfully trained the immune system to combat other infections. Although limited human data exists for these specific treatments, the underlying science is robust and shows great promise for preventing HIV infection.16789

Are You a Good Fit for This Trial?

This clinical trial is for healthy adult volunteers who do not have HIV. Participants should be in overall good health to join the study, which aims to test new vaccine candidates designed to prevent HIV.

Inclusion Criteria

Demonstrates an understanding of the study and is able and willing to complete the informed consent process
In good general health according to the clinical judgment of the site investigator
I can attend all clinic visits until the last one.
See 8 more

Exclusion Criteria

Body mass index (BMI) ≥40
I am not pregnant or breastfeeding.
My diabetes does not meet certain specific criteria.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DV201P-RNA at weeks 0 and 12, followed by DV202B1-RNA at weeks 24 and 40

40 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DV201P-RNA
  • DV202B1-RNA

Trial Overview

The trial is testing two experimental vaccines, DV201P-RNA and DV202B1-RNA. These are mRNA-based immunogens encapsulated in lipid nanoparticles aimed at inducing a specific immune response against HIV-1.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Group 4: TBD*Experimental Treatment1 Intervention
Group II: Group 3: 150 mcgExperimental Treatment2 Interventions
Group III: Group 2: 100 mcgExperimental Treatment2 Interventions
Group IV: Group 1: 50 mcgExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

Clinical Trial to Evaluate the Safety and Immunogenicity of ...

This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40464602/

Improved HIV-1 RNA detection using whole blood versus ...

Among 50 PWH starting ART at chronic infection stages, detectability was 24% in plasma and 92% in WB (P < 0.001). Among 345 PWH on ART since ...

(PDF) Research designs to generate evidence of HIV post‐ ...

HIV RNA testing conducted within 5 days of a potential exposure could define prevention per exposure. Novel recruitment venues—such as community‐based retail or ...

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Investigator's Brochure (IB) Table - daids rsc - NIH

DV201P-RNA and DV202B1-RNA - New, Duke Human Vaccine Institute (DHVI), December 2025. DV700P-RNA and DV701B1.1-RNA, Duke Human Vaccine Institute (DHVI) ...

APTIMA® HIV-1 RNA Qualitative Assay

Material Safety Data Sheets are available upon request. The following reagents contain 0.2% sodium azide as a preservative: Negative Calibrator. Positive ...

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The purpose of this study is to assess the safety and immune response to the HIV DNA vaccine, PENNVAX-B when given with and without an IL-12 adjuvant and ...

Oral Preexposure Prophylaxis Uptake and Discontinuation in ...

These important data show that offering oral PrEP as standard of prevention in future HIV-prevention, placebo-controlled efficacy trials will likely reduce HIV ...