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Virus Vaccine

FP conjugate vaccine (25 mcg) 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two HIV vaccines. The vaccines will be given alone or in combination with each other, and the scientists will observe how well the vaccines work and how safe they are.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Adverse events collected for all participants
Local reactogenicity signs and symptoms collected for all participants
Magnitude of serum antibody binding of FP and envelope trimer antigens as measured by the MSD assay 2 weeks after the last vaccination.
+2 more
Secondary outcome measures
Breadth of serum antibody neutralization, as measured by the TZM-bl assay.
Magnitude of CD4+ T-cell responses as assessed by intracellular cytokine staining assays (ICS).
Magnitude of serum IgG binding antibodies to FP, Trimer 4571, and Trimer 6931.
+5 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Prime Boost Regimen - Group 8Experimental Treatment5 Interventions
Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.
Group II: Prime Boost Regimen - Group 7Experimental Treatment5 Interventions
Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.
Group III: Prime Boost Regimen - Group 6Experimental Treatment4 Interventions
Prime Boost Regimen will evaluate the safety, tolerability, and immunogenicity of adjuvanted vaccines: FP conjugate prime, Trimer 4571 prime, or an FP plus Trimer 4571 prime, all followed by subsequent doses of Trimer 4571, Trimer 6931 and both Trimers combined.
Group IV: Dose Escalation - Group 5Experimental Treatment1 Intervention
Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Group V: Dose Escalation - Group 4Experimental Treatment1 Intervention
Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Group VI: Dose Escalation - Group 3Experimental Treatment1 Intervention
Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Group VII: Dose Escalation - Group 2Experimental Treatment1 Intervention
Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.
Group VIII: Dose Escalation - Group 1Experimental Treatment1 Intervention
Dose Escalation will evaluate the safety, tolerability, and immunogenicity of single adjuvanted doses of the FP conjugate, Trimer 4571 or Trimer 6931 vaccines, in a dose-escalation design. Each product must be assessed as safe prior to use in Prime Boost Regimen.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,519 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,889 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,072 Total Patients Enrolled

Frequently Asked Questions

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

What core aims has this investigation been designed to achieve?

"This trial will last 36 months and its primary outcome is to track systemic reactogenicity signs across all participants. Secondary outcomes comprise of measuring the breadth of serum antibody neutralization via TZM-bl assay, response rate of serum IgG binding antibodies on FP, Trimer 4571, and Trimer 6931 vaccines as well as mapping out the exact epitopes responsible for specific serum neutralizing activity."

Answered by AI

Do I meet the criteria for enrollment in this trial?

"This clinical trial is recruiting 60 persons aged 18 to 50 with HIV, who meet the additional criteria of being in good overall health, having a BMI ≤ 40 and WBCs ranging from 2,500-12,000/mm3. In addition they must consent to comply with study procedures through their last clinic visit as well as complete an informed consent process that assesses understanding prior to receiving the first vaccination. Furthermore participants can not enroll in another investigation agent during participation including SARS-CoV-2 agents which have obtained emergency use authorization or FDA licensure."

Answered by AI

What is the total participant count for this trial?

"To successfully complete this trial, 60 patients that align with the defined inclusion criteria must participate. These participants can be recruited from two different sites - Atlanta Hope Clinic in Georgia and University of Rochester Vaccines to Prevent HIV Infection CRS [31467] located in California."

Answered by AI

Is participation in this project still being accepted?

"According to the records on clinicaltrials.gov, this healthcare study has been actively searching for participants since its posting date of August 15th 2022 and is still ongoing as indicated by its most recent update from November 21st 2022."

Answered by AI

Has FP conjugate vaccine (25 mcg) achieved authorization from the FDA?

"Due to the limited data suggesting a measure of safety and efficacy, our team has assigned FP conjugate vaccine (25 mcg) with a score of 1."

Answered by AI

Is this experiment accommodating participants of advanced age?

"This research project is searching for participants aged 18 or older but not yet 50."

Answered by AI

How many locations are actively conducting this research trial?

"The locations offering this clinical trial include the Hope Clinic in Atlanta, University of Rochester Vaccines to Prevent HIV Infection CRS [31467] in Rochester, UCLA Vine Street Clinic CRS [31607], and additional sites across 7 regions."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults
2022. "A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05470400.
~25 spots leftby Jul 2025
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