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Cancer Vaccine

Group 1 (25 mcg) for Human Immunodeficiency Virus Infection

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
1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
2. 18 to 55 years old, inclusive, on day of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 months
Awards & highlights

Summary

This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are: 1. the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors, 2. the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and 3. these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.

Who is the study for?
This trial is for adults in good health who do not have HIV. It's designed to test the safety and potential of two new mRNA-based vaccines that aim to prepare the immune system against HIV.
What is being tested?
The study involves two experimental vaccines, CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160, which are given in stages to see if they can stimulate the body's immune cells to fight HIV more effectively.
What are the potential side effects?
As this is a first-in-human trial, specific side effects are unknown but may include typical vaccine reactions such as soreness at injection site, fever, fatigue, headache, muscle pain.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Magnitude of differential serum antibody neutralization of precursor detection virus and corresponding epitope KO virus, as measured by the TZM-bl assay
+8 more
Secondary study objectives
Epitope specific response rates as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Frequency of CD4-bs specific sequences, as measured by BCR single cell sequencing of CD4-bs and CH505M5-specific IgG+ B cells
Magnitude of serum Ab neutralization of autologous, heterologous and precursor HIV-1 strains as measured by TZM-bl assay
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4 (150 mcg)Experimental Treatment2 Interventions
150 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 150 mcg CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24.
Group II: Group 3 (100 mcg)Experimental Treatment2 Interventions
100 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 100 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24.
Group III: Group 2 (50 mcg)Experimental Treatment2 Interventions
50 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 50 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24.
Group IV: Group 1 (25 mcg)Experimental Treatment2 Interventions
25 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 25 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24.

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
3,289 Previous Clinical Trials
5,499,751 Total Patients Enrolled
Department of Health and Human ServicesFED
228 Previous Clinical Trials
929,669 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,754 Previous Clinical Trials
8,131,626 Total Patients Enrolled
~32 spots leftby Jun 2026
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