DV201P-RNA + DV202B1-RNA for HIV Prevention
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DV201P-RNA at weeks 0 and 12, followed by DV202B1-RNA at weeks 24 and 40
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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Treatment groups
Experimental Treatment
DV202B1-RNA (50 mcg or 100 mcg or 150 mcg; highest dose that is determined to be safe and well tolerated from Groups 1-3) at weeks 0 and 12.
DV201P-RNA (150 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (150 mcg) at weeks 24 and 40.
DV201P-RNA (100 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (100 mcg) at weeks 24 and 40.
DV201P-RNA (50 mcg) at weeks 0 and 12. Followed by: DV202B1-RNA (50 mcg) at weeks 24 and 40.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
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3.
researchgate.net
researchgate.net/publication/393057229_Research_designs_to_generate_evidence_of_HIV_post-exposure_prophylaxis_effectiveness_for_new_long-acting_agents(PDF) Research designs to generate evidence of HIV post‐ ...
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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
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These important data show that offering oral PrEP as standard of prevention in future HIV-prevention, placebo-controlled efficacy trials will likely reduce HIV ...
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