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Virus Therapy

Part A - Group 1 for HIV/AIDS

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

18 to 55 years old on day of enrollment

Negative for anti-Hepatitis C virus (HCV) Abs or negative HCV nucleic acid test if anti-HCV Abs are detected

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 31 months

Awards & highlights

Study Summary

This trial is testing two HIV vaccines with adjuvants to see if they can help people develop an immune response against the virus that causes AIDS. It involves 42 participants at multiple sites in the

Who is the study for?

This trial is for adults without HIV who are in good health. Participants will be part of a study testing two experimental HIV vaccines combined with different adjuvants to boost immune response. The trial excludes individuals under certain medications, those with immune system issues, or anyone with conditions that might interfere with the study.Check my eligibility

What is being tested?

The clinical trial is evaluating the safety and effectiveness of two HIV vaccine candidates: CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer. These are given alongside adjuvants—either Lipid Nanoparticles (LNPs) or 3M-052-AF plus Alum—to enhance immunity.See study design

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as pain at injection site, fever, fatigue, headache, muscle pain, joint pain and possibly allergic reactions to components of the vaccines or adjuvants.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 55 years old.

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I do not have hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 31 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~31 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 months 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 local reactogenicity signs and symptoms after receipt of any study vaccine

Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine

Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation

+6 more

Secondary outcome measures

Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry

Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay

Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay

+8 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part C - Group 7Experimental Treatment4 Interventions

100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group II: Part C - Group 6Experimental Treatment4 Interventions

100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, Followed by 300 mcg of CH505TF chTrimer, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group III: Part C - Group 5Experimental Treatment3 Interventions

Low dose: 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, Followed by 300 mcg of CH505TF chTrimer, admixed with 1mg empty LNP adjuvant to be administered at months 6 and 8. OR, High Dose: 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-01 adjuvant to be administered as two 0.5 mL doses intramuscularly at month 0, 2, and 4, Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group IV: Part B - Group 4Experimental Treatment4 Interventions

60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group V: Part B - Group 3Experimental Treatment3 Interventions

60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group VI: Part B - Group 2Experimental Treatment3 Interventions

60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 Followed by 300 mcg of CH505TF chTrimer, admixed with 1.0 mcg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group VII: Part A - Group 1Experimental Treatment1 Intervention

• 60 mcg of CD4BS CH505M5 Pr-NP1, to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4.

0 / 2Eligibility criteria met

Find a Location

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

5,481,090 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,546 Total Patients Enrolled

Duke UniversityOTHER

2,358 Previous Clinical Trials

3,420,027 Total Patients Enrolled

Frequently Asked Questions

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

How prevalent is the participation of medical centers within our region in this study?

"This clinical trial is active in 6 locations, such as The Ponce de Leon Center CRS (Site ID: 5802) based in Atlanta, the Vanderbilt Vaccine (VV) CRS (Site ID: 30352) located in Nashville, and the Setshaba Research Centre CRS (Site ID: 31829) situated in Soshanguve."

Answered by AI

Has Part A - Group 1 received official approval from the FDA?

"Our evaluation at Power indicates that the safety rating for Part A - Group 1 is a level 1 on the scale of 3. This assessment aligns with it being a Phase 1 trial, where there exists restricted evidence backing its safety and efficacy."

Answered by AI

Are individuals over the age of 30 being sought for enrollment in this research study?

"To be considered for this research study, individuals must be at least 18 years old but no older than 55."

Answered by AI

Are individuals currently being admitted to participate in this trial?

"As per clinicaltrials.gov, this specific trial is presently not seeking participants. Although it was initially listed on 5/31/2024 and last revised on 2/12/2024, there are currently 236 alternative trials actively searching for eligible individuals to join their research studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum

2024. "A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06267872.