DV700P-RNA + DV701B1.1-RNA for HIV

Recruiting at 5 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

Trial Summary

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.

What data supports the effectiveness of the treatment 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 different parts of the virus. These strategies have shown promise in long-term suppression of HIV in various studies, suggesting potential effectiveness for this treatment. ^{1 2 3 4 5}

Is the treatment DV700P-RNA + DV701B1.1-RNA generally safe for humans?

The treatment includes rilpivirine, which has been studied in combination with other drugs and found to be generally well-tolerated in humans, with some mild to moderate side effects reported. In one study, only one serious adverse event was noted, which was unrelated to the treatment, and the treatment was well tolerated overall. ^{6 7 8 9 10}

How does the drug DV700P-RNA + DV701B1.1-RNA for HIV differ from other treatments?

The drug DV700P-RNA + DV701B1.1-RNA for HIV is unique because it targets the RNA dimerization process, which is crucial for the HIV virus to replicate. This approach is different from standard treatments that typically focus on inhibiting viral enzymes or blocking virus entry into cells. ^{11 12 13 14 15}

What is the purpose of this trial?

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 tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease). Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.

Eligibility Criteria

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.

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

Received other vaccines within 14 days before enrollment

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

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2. United States pubmed.ncbi.nlm.nih.gov

Long-term inhibition of HIV-1 infection in primary hematopoietic cells by lentiviral vector delivery of a triple combination of anti-HIV shRNA, anti-CCR5 ribozyme, and a nucleolar-localizing TAR decoy. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized, open-label, comparative trial of zidovudine plus lamivudine versus zidovudine plus lamivudine plus didanosine in antiretroviral-naive HIV-1-infected Thai patients. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Specific HIV-1 env gene silencing by small interfering RNAs in human peripheral blood mononuclear cells. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Inhibition of HIV-1 replication by RNA-based strategies. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

In Vitro Cross-Resistance Profiles of Rilpivirine, Dapivirine, and MIV-150, Nonnucleoside Reverse Transcriptase Inhibitor Microbicides in Clinical Development for the Prevention of HIV-1 Infection. [2018]

7. England pubmed.ncbi.nlm.nih.gov

96-week results of a dual therapy with darunavir/ritonavir plus rilpivirine once a day vs triple therapy in patients with suppressed viraemia: virological success and non-HIV related morbidity evaluation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety, and tolerability with repeat doses of GSK1265744 and rilpivirine (TMC278) long-acting nanosuspensions in healthy adults. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Once-daily Doravirine in Human Immunodeficiency Virus Type 1-Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Metabolic Profile in PLWHIV Switching to Doravirine-Based Regimen. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of viral genomic RNA sorting mechanisms in human immunodeficiency virus type 1 (HIV-1), HIV-2, and Moloney murine leukemia virus. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A kissing complex together with a stable dimer is involved in the HIV-1Lai RNA dimerization process in vitro. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

Identification of the in vitro HIV-2/SIV RNA dimerization site reveals striking differences with HIV-1. [2021]

14. Spain pubmed.ncbi.nlm.nih.gov

HIV-1 RNA dimerization: It takes two to tango. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

In vitro dimerization of human immunodeficiency virus type 1 (HIV-1) spliced RNAs. [2021]