42 Participants NeededMy employer runs this trial

mRNA Vaccines for HIV

Recruiting at 19 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Antiretrovirals
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 evaluates two experimental mRNA vaccines, DV700P-RNA and DV701B1.1-RNA, for individuals living with HIV to determine their safety and effectiveness in enhancing the immune response against the virus. Researchers are also examining the impact of a short break from regular HIV medication (antiretroviral therapy) on the immune response. Individuals in good health, living with HIV, and stable on their HIV medications may qualify for this study. 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 this new treatment.

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

The trial requires participants to be on stable antiretroviral therapy (ART) for at least 48 weeks before joining, but it does not specify if you need to stop other medications. However, there is a planned pause in ART during the study, so you should discuss your specific medications with the study team.

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

Research has shown that the experimental mRNA vaccines, DV700P-RNA and DV701B1.1-RNA, are being tested for safety and tolerance. These vaccines aim to help the body produce antibodies against HIV. The studies have primarily focused on ensuring the vaccines do not cause serious discomfort or major side effects. Participants in these studies were generally healthy, and tests revealed no significant safety issues. As these are early trials, the primary goal is to confirm the vaccines' safety for human use.12345

Why are researchers excited about this trial's treatments?

Unlike the standard HIV treatments, which primarily involve antiretroviral therapies that suppress the virus, the mRNA vaccines DV700P-RNA and DV701B1.1-RNA aim to prevent infection by training the immune system to recognize and fight HIV before it can establish itself in the body. These vaccines use mRNA technology, similar to what was used in some COVID-19 vaccines, which is a novel approach for HIV prevention. Researchers are excited about these treatments because they have the potential to provide long-lasting immunity and could revolutionize how we approach HIV prevention, moving from managing the disease to potentially stopping it before it starts.

What evidence suggests that these mRNA vaccines could be effective for HIV?

This trial will evaluate two mRNA vaccines, DV700P-RNA and DV701B1.1-RNA, for HIV. Research has shown that RNA-based methods, like those used in these vaccines, can effectively reduce HIV by directly targeting the virus. This approach helps stop the virus from multiplying in the body. Although these vaccines are new, the mRNA technology behind them has shown promise in other diseases, such as COVID-19, by teaching the immune system to recognize and fight the virus. Early studies suggest that these vaccines could initiate or strengthen the body's antibody response, providing a defense against viruses like HIV. While more research is needed, these initial findings offer hope for developing an effective HIV vaccine.13467

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 living with HIV who are in good health, have been on stable HIV treatment for at least a year, have well-controlled virus levels, and meet certain immune cell counts. Participants must be able to follow study procedures and not join other studies during this time.

Inclusion Criteria

* Agrees not to participate in another investigational study during participation unless approved.
* Able and willing to provide informed consent.
* Lowest (nadir) CD4+ count between 250 and 450 cells/mm³.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DV700P-RNA and DV701B1.1-RNA immunizations at specified intervals

16 weeks
3 visits (in-person)

Analytical Treatment Interruption (ATI)

Participants undergo a planned pause in antiretroviral therapy to assess immune response

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment and ART restart

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DV700P-RNA
  • DV701B1.1-RNA

Trial Overview

Researchers are testing the safety of two experimental mRNA vaccines (DV700P-RNA and DV701B1.1-RNA) given together to people with HIV. The study also includes a carefully monitored pause in regular HIV medication to see how the vaccines affect immune responses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions
Group II: Group 1Experimental 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+

Department of Health and Human Services

Collaborator

Trials
240
Recruited
944,000+

Department of Health and Human Services (HHS)

Collaborator

Duke University

Collaborator

Trials
2,495
Recruited
5,912,000+

Citations

A Trial to Evaluate the Safety and Tolerability of DV700P ...

This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with ...

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 ...

A Study to Evaluate the Safety and Immunogenicity ...

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 ...

Recent advances in HIV-1 envelope-based vaccine designs ...

Despite promising preclinical data, clinical trials have produced mixed outcomes, highlighting the need to optimize vaccine vectors and the ...

mRNA-based vaccine technology for HIV - PMC - NIH

This article provides an overview over HIV infection and introduces mRNA vaccines and their potential in HIV vaccine development.

Clinical Trial Details

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

A Study to Evaluate the Safety and Immunogenicity ...

Generally healthy according to the study doctor. Physical exam and lab results show no major issues that could affect safety or studyresults.