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Cancer Vaccine

HIV Vaccine for HIV Infection (NETI Trial)

Q: Has the administration approved Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant?

Based on the current evidence, our team at Power has assigned Trimer 4571 <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a> 500mcg with 500 mcg alum adjuvant a rating of 1. This reflects that it is currently in Phase 1 clinical trials and there are limited data points evidencing safety or efficacy.

Q: What is the total enrollment figure for this research project?

Affirmative. Information hosted on clinicaltrials.gov indicates that this study, which was initially published on September 30th 2021, is actively searching for trial participants. Consequently, 32 patients will need to be recruited from two separate medical centres.

Q: Are there any vacancies left for participants in this clinical trial?

Affirmative. According to the clinicaltrials.gov listing, this investigation is still recruiting participants that it first posted for on September 30th 2021. 32 candidates need to be sourced from 2 different sites.

Phase 1

Recruiting

Led By Madhu Choudhary, MD

Research Sponsored by Madhu Chhanda Choudhary

Eligibility Criteria Checklist

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

Must have

Receiving continuous antiretroviral therapy (ART) for at least 24 months with no interruptions longer than 30 consecutive days and no changes in the components of the ART for at least 8 weeks prior to study entry

Plasma HIV-1 RNA levels < 50 copies/ml for at least 24 months on ART prior to study entry with at least one documented HIV-1 RNA < 50 copies/ml within 12 months prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through week 44

Awards & highlights

NETI Trial Summary

This trial is testing an investigational vaccine to see if it is safe and effective in stimulating the production of broadly neutralizing antibodies against HIV.

Who is the study for?

Adults over 18 living with HIV on stable antiretroviral therapy (ART) for at least 24 months, with undetectable viral loads and no history of severe allergies or chronic inflammatory conditions. Participants must not be pregnant, breastfeeding, or have a BMI over 40kg/m2, and should agree to use contraception during the trial.Check my eligibility

What is being tested?

The Trimer 4571 vaccine is being tested in two different doses combined with alum as an adjuvant against placebo controls. The study aims to see if it's safe for people with HIV and whether it can stimulate the immune system to produce antibodies against HIV.See study design

What are the potential side effects?

As Trimer 4571 is investigational and new to humans with HIV, potential side effects are not fully known but may include typical vaccine reactions like soreness at injection site, fever, fatigue or allergic responses.

NETI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on consistent HIV medication for at least 2 years without a break longer than 30 days.

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My HIV-1 levels have been under control for at least 2 years with treatment.

NETI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through week 44

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through week 44

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through week 44 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety and tolerability of three vaccinations of Trimer 4571 vaccine in adults with HIV on suppressive ART

Secondary outcome measures

HIV

NETI Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Randomized Blinded Trimer 4571 Vaccine 500mcgExperimental Treatment1 Intervention

Eighteen (18) participants will receive Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group II: Randomized Blinded Trimer 4571 Vaccine 100mcgExperimental Treatment1 Intervention

Six (6) participants will receive Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group III: Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcgPlacebo Group1 Intervention

Two (2) participants will receive the placebo control for Trimer 4571 vaccine 100mcg as a 1ml intramuscular injection at Day 0, Week 8 and Week 20.

Group IV: Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcgPlacebo Group1 Intervention

Six (6) participants will receive the placebo control for Trimer 4571 vaccine 500mcg as a 1.1ml intramuscular injection at Day 0, Week 8 and Week 20.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Madhu Chhanda ChoudharyLead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,274 Previous Clinical Trials

5,484,328 Total Patients Enrolled

Madhu Choudhary, MDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

Trimer 4571 Therapeutic Vaccination (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04985760 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: Randomized Blinded Trimer 4571 Vaccine 100mcg, Randomized Blinded Placebo for Trimer 4571 Vaccine 100mcg, Randomized Blinded Trimer 4571 Vaccine 500mcg, Randomized Blinded Placebo for Trimer 4571 Vaccine 500mcg

Human Immunodeficiency Virus Infection Clinical Trial 2023: Trimer 4571 Therapeutic Vaccination Highlights & Side Effects. Trial Name: NCT04985760 — Phase 1

Trimer 4571 Therapeutic Vaccination (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04985760 — Phase 1

Frequently Asked Questions

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

Has the administration approved Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant?

"Based on the current evidence, our team at Power has assigned Trimer 4571 vaccine 500mcg with 500 mcg alum adjuvant a rating of 1. This reflects that it is currently in Phase 1 clinical trials and there are limited data points evidencing safety or efficacy."

Answered by AI

What is the total enrollment figure for this research project?

"Affirmative. Information hosted on clinicaltrials.gov indicates that this study, which was initially published on September 30th 2021, is actively searching for trial participants. Consequently, 32 patients will need to be recruited from two separate medical centres."

Answered by AI

Are there any vacancies left for participants in this clinical trial?

"Affirmative. According to the clinicaltrials.gov listing, this investigation is still recruiting participants that it first posted for on September 30th 2021. 32 candidates need to be sourced from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy

Madhu Chhanda Choudhary 2021. "Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04985760.

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