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Virus Therapy

CH505 TF chTrimer Vaccine for HIV Prevention

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up thru week 104

Awards & highlights

Study Summary

This trial is testing a new vaccine and adjuvant combination to see if it is safe and causes an immune response in healthy adults.

Who is the study for?

Healthy adults aged 18-55 who are not pregnant, breastfeeding, or at high risk for HIV. Participants must be in good health, available for follow-up visits, willing to undergo certain medical procedures like lymph node aspiration and leukapheresis, and agree to use effective birth control. Exclusions include recent receipt of blood products or certain vaccines, serious vaccine reactions, asthma requiring frequent steroid use or emergency care, immune-mediated diseases, drug abuse history.Check my eligibility

What is being tested?

The trial is testing the CH505 TF chTrimer vaccine with different doses of the adjuvants 3M-052-AF and Alum to evaluate safety and how well it generates an immune response (immunogenicity). Part A uses a specific dose combination while Part B tests varying doses/combinations to find the best balance between effectiveness and side effects.See study design

What are the potential side effects?

Potential side effects may include local reactions at injection site (pain or swelling), general symptoms like fever or fatigue after vaccination. Since this is a Phase 1 study primarily focused on safety/immunogenicity assessment rather than efficacy against disease transmission; detailed side effect profiles will be determined during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ thru week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~thru week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and thru week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of CD4 binding-site-specific IgG+ B cells

Frequency of CH505TF-specific IgG+ B cells

Frequency of v2 apex and V3 glycan- specific IgG+ B cells

+9 more

Secondary outcome measures

Magnitude of serum IgG binding antibodies

Magnitude of serum antibody neutralization of heterologous HIV-1 strains

Response rate of serum IgG binding antibodies

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: TreatmentExperimental Treatment2 Interventions

CH505 chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group II: Group 3: TreatmentExperimental Treatment3 Interventions

CH505 cTrimer, 300 mcg admixed with (3 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide Ssuspension (Alum) administered at months 0, 2, 4, 8 and 12.

Group III: Group 2: TreatmentExperimental Treatment2 Interventions

CH505 TF chTrimer 300 mcg admixed with (3 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Group IV: Group 1:TreatmentExperimental Treatment3 Interventions

CH505 TF chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide suspension, administered at months 0, 2, 4, 8 and 12.

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

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

3,268 Previous Clinical Trials

5,481,080 Total Patients Enrolled

Kenneth H Mayer, M.D.Study ChairBeth Israel Deaconess Medical Center

Lindsey R Baden, M.D.Study ChairBrigham and Women's Hospital

Media Library

CH505 TF chTrimer (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04915768 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: Group 3: Treatment, Group 4: Treatment, Group 1:Treatment, Group 2: Treatment

Human Immunodeficiency Virus Infection Clinical Trial 2023: CH505 TF chTrimer Highlights & Side Effects. Trial Name: NCT04915768 — Phase 1

CH505 TF chTrimer (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04915768 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this research study for participants?

"Unfortunately, this clinical trial is not currently accepting applications. It was first posted on May 3rd 2021 and the last update was seen on January 31st 2022. If you are looking for other research opportunities, there are 484 trials actively seeking patients with HIV infections as well as 2 studies related to CH505 TF chTrimer that require participants."

Answered by AI

What is the current enrollment for this research study?

"At present, this trial is not recruiting any participants. It was first posted on the 3rd of May 2021 and last modified on 31st January 2022. If you are still seeking other studies, there are presently 484 clinical trials enrolling HIV-positive individuals and 2 for CH505 TF chTrimer looking for patients to join their experiment."

Answered by AI

What is the most prevalent condition that CH505 TF chTrimer has been utilized to treat?

"CH505 TF chTrimer is a well-known remedy for colic symptoms, but also has beneficial effects on acid regurgitation, gastroesophageal reflux disease, and related abdominal pain."

Answered by AI

Is this clinical trial pioneering within its field?

"Research for CH505 TF chTrimer has been underway since 2020, initiated by Dynavax Technologies Corporation. After the successful Phase 1 trial of 105 participants in that year, it received its drug approval and is currently being studied at 2 active sites across 9 cities and one nation."

Answered by AI

Does your research include elderly participants?

"According to trial stipulations, those enrolled must be 18 years or older but not exceed the age of 55. There are 108 trials available for children and 352 studies accessible to seniors."

Answered by AI

Is there a particular demographic that would be best suited to participate in this investigation?

"Aspiring participants should have HIV and be aged between 18-55 to qualify for this clinical trial. This research project is aiming to recruit 12 individuals in total."

Answered by AI

Has CH505 TF chTrimer been given the regulatory nod?

"Due to its Phase 1 status, CH505 TF chTrimer possesses a low safety rating of 1 according to Power's evaluation system. This is because there is only limited evidence attesting to the drug's efficacy and no verifiable data about its security."

Answered by AI

Can you provide insight into any additional experiments which have been conducted regarding CH505 TF chTrimer?

"Currently, there are two clinical trials running for CH505 TF chTrimer. Neither of these active studies is in Phase 3. While the primary trial site is located in Birmingham, Alabama, 11 other medical centres have taken part in this treatment's development."

Answered by AI

What goal is this clinical experiment attempting to accomplish?

"Over a week's time, this trial aims to gauge the response rate of serum antibody neutralization for vaccine-matched tier 2 HIV-1 strains. Other objectives include assessing the magnitude of heterologous HIV-1 strain responses through binding Ab multiplex assay (BAMA), HZM-b1 assay and TZM-b1 assay."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

2023. "Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915768.

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