54 Participants NeededMy employer runs this trial

CH505 HIV Vaccine for HIV/AIDS

Recruiting at 7 trial locations
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Stay on Your Current MedsYou can continue your current medications while participating
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 aims to test a new HIV vaccine to assess its safety and ability to trigger the right immune responses in healthy adults without HIV. Participants will receive different combinations of a protein-based vaccine or an mRNA vaccine (such as CH505 TF mRNA-gp160), along with a special ingredient to boost the immune response. The trial will also examine how the location of booster shots affects immune reactions. Healthy individuals without HIV, who haven't recently received certain vaccines or medications, might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that might impair your immune response, such as certain steroids, you may need to discuss this with the trial team.

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

A previous study found the CH505 mRNA vaccine to be safe. Most side effects were mild, such as soreness at the injection site or a slight fever, while serious side effects were rare. Similar studies on the DV901-NP and DV902-NP vaccines in healthy adults showed that side effects were usually mild and temporary, with common issues including minor pain at the injection site and mild tiredness. As this study is in its early phase, the main goal is to assess the vaccine's safety. This stage helps researchers determine if the vaccine is safe enough for further testing.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for HIV/AIDS because they use innovative vaccine formulations like CH505 TF mRNA-gp160 and DV901-NP, which show promise in stimulating the immune system differently than current options. Unlike standard antiretroviral therapies that suppress the virus, these vaccines aim to train the body’s immune system to recognize and fight HIV more effectively. The use of mRNA technology in these vaccines is particularly exciting as it represents a cutting-edge approach that has shown success in other areas, like COVID-19 vaccines, potentially offering a new way to prevent or manage HIV infections.

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

Research has shown that the DV901-NP and DV902-NP vaccines, part of the current trial, produced promising results in animals, suggesting potential in fighting AIDS. Some studies report strong immune responses, crucial for preventing HIV infection. Although protection may decrease over time, these vaccines initially provided significant defense against the virus.

Similarly, the CH505 mRNA-gp160 vaccine, another treatment option in this trial, demonstrated strong immune responses in earlier trials, exceeding the necessary level for potential effectiveness. This vaccine is designed to help the body produce specific defenses against HIV. While more research is needed, these early results are encouraging for future HIV prevention efforts.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55 who do not have HIV, hepatitis B or C, and are willing to use effective birth control if needed. Participants must be in good health with normal lab results and blood pressure, and cannot have certain allergies, immune problems, recent vaccines, or serious medical conditions.

Inclusion Criteria

White blood cell count of 2,500 to 12,000/mm3; WBC over 12,000/mm3 allowed with further evaluation and approval
Platelet count of 125,000 to 550,000/mm3
Alanine aminotransferase (ALT) less than 2.5 times the upper limit of institutional reference range
See 17 more

Exclusion Criteria

I have angioedema, either inherited, acquired, or of unknown cause.
I have not received blood products or immunoglobulin in the past 16 weeks.
I have received a vaccine within the last 14 days.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DV901-NP adjuvanted with ACU-026-001-1, followed by either DV902-NP or CH505 mRNA vaccine boosters

32 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACU-026-001-1
  • CH505 TF mRNA-gp160
  • CH505 w24 mRNA-gp160
  • DV901-NP
  • DV902-NP

Trial Overview

The study is testing new CH505 HIV vaccine regimens using protein nanoparticles and mRNA boosters in healthy adults. It aims to see how safe these vaccines are and how well they trigger an immune response against HIV. Some participants will also help test if the injection site affects immunity.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Group 5: Ipsilateral Prime/Ipsilateral Boost Immunology CohortExperimental Treatment2 Interventions
Group II: Group 4: Ipsilateral Prime/Contralateral Boost Immunology CohortExperimental Treatment2 Interventions
Group III: Group 3: DV901-NP Prime/CH505 mRNA BoostsExperimental Treatment4 Interventions
Group IV: Group 2: DV901-NP High-Dose Prime/DV902-NP High-Dose BoostExperimental Treatment3 Interventions
Group V: Group 1: DV901-NP Low-Dose Prime/DV902-NP Low-Dose BoostExperimental Treatment3 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

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