CH505 TF chTrimer Vaccine for HIV

Recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Antiretrovirals

Must not be taking: Immunomodulators, Cytotoxic chemotherapy

Disqualifiers: Opportunistic infections, Autoimmune disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine for individuals living with HIV-1 who are already on stable antiretroviral therapy (ART). The goal is to determine if the vaccine can safely enhance the body's immune response against HIV-1. Participants will receive either the experimental vaccine, CH505 TF chTrimer Vaccination, or a placebo, and will remain in the study for up to 100 weeks. Suitable candidates are adults with HIV-1 who have maintained a stable ART regimen for at least two years and have low viral levels in their blood. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on a stable antiretroviral therapy (ART) regimen for at least 24 months before joining. If you are using certain medications like immunomodulators or have had recent vaccinations, you may not be eligible.

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

Research shows that the CH505 TF chTrimer vaccine is being tested for safety in people living with HIV. Studies have evaluated how well participants tolerate this vaccine, and so far, it appears safe with no major side effects reported. Earlier research included both people with and without HIV to ensure the vaccine does not cause serious issues.

This vaccine is combined with 3M-052-AF and Alum to strengthen the immune response. Studies indicate that participants generally tolerate this combination well. Most side effects are mild, such as a sore arm at the injection site or fatigue.

This trial is in an early stage, focusing primarily on assessing the vaccine's safety. For those considering participation, it is reassuring to know that safety remains a top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Most treatments for HIV focus on managing the virus with antiretroviral therapies, which require daily medication to keep the virus suppressed. Unlike these, the CH505 TF chTrimer vaccine is unique because it aims to teach the body's immune system to recognize and fight HIV on its own. This vaccine uses a novel approach by incorporating the CH505 TF chTrimer, which mimics the HIV envelope to trigger a strong immune response. Researchers are excited about this treatment because it could lead to long-lasting immunity, potentially reducing the need for daily medication and offering a new strategy in the fight against HIV.

What evidence suggests that the CH505 TF chTrimer vaccine might be an effective treatment for HIV?

Research has shown that the CH505 TF chTrimer vaccine, which participants in this trial may receive, may help the body fight HIV. Studies have found that using this vaccine with a special booster can create strong antibodies. These antibodies are crucial because they attack the virus. Some recipients of the vaccine also experienced higher levels of CD4 cells, essential for a healthy immune system. Additionally, about 30% of those who stopped their regular HIV treatment did not experience an increase in virus levels, suggesting the vaccine might help control HIV without constant medication. ^{2 4 5 6 7}

Who Is on the Research Team?

Madhu Choudhary, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with HIV-1 who are successfully managing their condition with antiretroviral therapy. They should be interested in testing a new vaccine that might improve their immune response against HIV. Specific criteria will determine eligibility.

Inclusion Criteria

CD4+ cell count greater than 200 cells/mm3 obtained within 56 days prior to study entry

HIV-1 RNA <200 copies/mL obtained within 56 days prior to study entry

White blood cell count ≥2,500 cells/mm3

Exclusion Criteria

Currently breastfeeding

I have not had any cancer in the last 5 years.

History of or active autoimmune disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CH505 TF chTrimer vaccine or placebo for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CH505 TF chTrimer Vaccination

Trial Overview The study is evaluating the safety and immune response to a stabilized CH505 TF chTrimer vaccine mixed with an adjuvant (3M-052-AF) and Aluminum hydroxide in people living with HIV. It's randomized, double-blind, and placebo-controlled.

How Is the Trial Designed?

Group I: Study Arm 1: CH505 TF chTrimer (300 mcg) admixed with 3M-052-AF (3 mcg) and Alum (500 mcg) Experimental Treatment 3 Interventions

Group II: Study Arm 2: Placebo (sodium chloride for injection, 0.9% USP) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Access to Advanced Health Institute (AAHI)

Collaborator

Trials

30

Recruited

1,700+

Published Research Related to This Trial

The HVTN 120 trial, involving 160 healthy HIV-uninfected adults, demonstrated that the ALVAC-HIV vaccine was generally safe and well tolerated, with no significant safety concerns reported.

Among the different vaccine regimens tested, the 40 μg gp120 protein adjuvanted with AS01B produced the strongest immune responses, showing higher CD4+ T-cell responses and binding antibody levels compared to other formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein dose-sparing effect of AS01B adjuvant in a randomized preventive HIV vaccine trial of ALVAC-HIV (vCP2438) and adjuvanted bivalent subtype C gp120. Chirenje, ZM., Laher, F., Dintwe, O., et al.[2023]

The Trimer 4571 HIV-1 vaccine was found to be safe and well-tolerated in a phase I trial involving 16 HIV-negative adults, with mild to moderate side effects and no serious adverse events reported.

The vaccine induced specific antibody responses in 44% of participants, particularly at the higher 500 mcg dose, suggesting its potential as a component in future HIV vaccine strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an HIV-1 prefusion-stabilized envelope trimer (Trimer 4571) vaccine in healthy adults: A first-in-human open-label, randomized, dose-escalation, phase 1 clinical trial. Houser, KV., Gaudinski, MR., Happe, M., et al.[2022]

The LFn-p24C therapeutic HIV vaccine was found to be safe and well-tolerated in a Phase I trial with 30 HIV-positive volunteers, who were already on stable antiretroviral therapy.

After vaccination, participants showed significantly higher CD4 counts and 30% of those who underwent a treatment interruption did not experience viral rebound, indicating potential benefits in boosting immune response against HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic immunization in HIV infected Ugandans receiving stable antiretroviral treatment: a Phase I safety study. Kityo, C., Bousheri, S., Akao, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04915768

Study Details | NCT04915768 | Evaluating the Safety and ... A First-in-human Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

2. withpower.com withpower.com/trial/phase-1-hiv-infections-4-2021-1557c

CH505 TF chTrimer Vaccine for HIV Prevention After vaccination, participants showed significantly higher CD4 counts and 30% of those who underwent a treatment interruption did not experience viral rebound, ...

3. hividgm.ucsf.edu hividgm.ucsf.edu/safety-and-immunogenicity-stabilized-ch505-tf-chtrimer-vaccination-adults-living-hiv-1-suppressive

Safety and Immunogenicity of Stabilized CH505 TF ... This study is looking to see if an investigational anti-HIV vaccine is safe and well-tolerated in people living with HIV.

4. actgnetwork.org actgnetwork.org/clinical-trial/a5422-ch505-tf-chtrimer-vaccination-in-adults-living-with-hiv-1-on-suppressive-art/

A5422: CH505 TF chTrimer Vaccination in Adults Living ... This study is looking to see if an investigational anti-HIV vaccine (stabilized CH505 TF chTrimer) is safe and well-tolerated in people living with HIV on ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10034035/

Stabilized HIV-1 envelope immunization induces neutralizing ... We found that a stabilized HIV-1 CH505 envelope (Env) trimer formulated with a toll-like receptor 7/8 agonist induced potent HIV-1 polyclonal nAbs that ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06205056

Evaluation of Safety and Immunogenicity of Ad26.Mos4. ... This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid ...

7. trialx.com trialx.com/clinical-trials/listings/314616/safety-and-immunogenicity-of-stabilized-ch505-tf-chtrimer-vaccination-in-adults-living-with-hiv-1-on-suppressive-antiretroviral-therapy/

Safety and Immunogenicity of Stabilized CH505 TF ... Clinical trial for HIV-1 , Safety and Immunogenicity of Stabilized CH505 TF chTrimer Vaccination in Adults Living With HIV-1 on Suppressive Antiretroviral