FP conjugate vaccine (25 mcg) for HIV

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York Blood Center CRS [31801], New York, NY
HIV
FP conjugate vaccine (25 mcg) - Biological
Eligibility
18 - 65
All Sexes
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Study Summary

This is an open-label, dose-escalation study to examine the safety, tolerability, and immunogenicity of adjuvanted Fusion Peptide Vaccine alone or in prime-boost regimens with adjuvanted Trimer 4571 and Trimer 6931 vaccines in healthy adults. The hypothesis is that the vaccines will be safe, and well tolerated when administered alone, and when co-administered with HIV-1 Trimer 4571, in prime-boost regimens, and will induce detectable immune response.

Treatment Effectiveness

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: 36 months

36 months
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.
Magnitude of serum antibody binding of FP and envelope trimer antigens as measured by the MSD assay 2 weeks after the last vaccination.
Magnitude of serum antibody neutralization, as measured by the TZM-bl assay.
Mapping of FP specific serum neutralizing activity via characterization of specific epitopes (such as base of trimers, V3, internal epitopes).
Response rate of CD4+ T-cell responses as assessed by intracellular cytokine staining assays (ICS).
Response rate of serum IgG binding antibodies to FP, Trimer 4571, and Trimer 6931.
Response rate of serum antibody binding of FP and envelope trimer antigens as measured by the MSD assay 2 weeks after the last vaccination.
Response rate of serum antibody neutralization, as measured by the TZM-bl assay.
Collected for thirty days after any receipt of study vaccination
Adverse events collected for all participants
Measured for a minimum of seven days following receipt of any study product
Local reactogenicity signs and symptoms collected for all participants
Systemic reactogenicity signs and symptoms collected for all participants

Trial Safety

Trial Design

8 Treatment Groups

Dose Escalation - Group 3
1 of 8
Prime Boost Regimen - Group 6
1 of 8
Dose Escalation - Group 2
1 of 8
Dose Escalation - Group 1
1 of 8
Dose Escalation - Group 5
1 of 8
Prime Boost Regimen - Group 8
1 of 8
Dose Escalation - Group 4
1 of 8
Prime Boost Regimen - Group 7
1 of 8
Experimental Treatment

60 Total Participants · 8 Treatment Groups

Primary Treatment: FP conjugate vaccine (25 mcg) · No Placebo Group · Phase 1

Dose Escalation - Group 3
Biological
Experimental Group · 1 Intervention: Trimer 6931 (100 mcg) · Intervention Types: Biological
Prime Boost Regimen - Group 6Experimental Group · 4 Interventions: Trimer 6931 (100 mcg), Trimer 4571 (200 mcg), Trimer 6931 (200 mcg), Trimer 4571 (100 mcg) · Intervention Types: Biological, Biological, Biological, Biological
Dose Escalation - Group 2
Biological
Experimental Group · 1 Intervention: FP conjugate vaccine (200 mcg) · Intervention Types: Biological
Dose Escalation - Group 1
Biological
Experimental Group · 1 Intervention: FP conjugate vaccine (25 mcg) · Intervention Types: Biological
Dose Escalation - Group 5
Biological
Experimental Group · 1 Intervention: Trimer 4571 (200 mcg) · Intervention Types: Biological
Prime Boost Regimen - Group 8Experimental Group · 5 Interventions: Trimer 6931 (100 mcg), FP conjugate vaccine (200 mcg), Trimer 4571 (200 mcg), Trimer 6931 (200 mcg), Trimer 4571 (100 mcg) · Intervention Types: Biological, Biological, Biological, Biological, Biological
Dose Escalation - Group 4
Biological
Experimental Group · 1 Intervention: Trimer 6931 (200 mcg) · Intervention Types: Biological
Prime Boost Regimen - Group 7Experimental Group · 5 Interventions: Trimer 6931 (100 mcg), FP conjugate vaccine (200 mcg), Trimer 4571 (200 mcg), Trimer 6931 (200 mcg), Trimer 4571 (100 mcg) · Intervention Types: Biological, Biological, Biological, Biological, Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Closest Location: New York Blood Center CRS [31801] · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching HIV
0 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,108 Previous Clinical Trials
4,672,384 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,390 Previous Clinical Trials
24,521,497 Total Patients Enrolled
Department of Health and Human ServicesFED
197 Previous Clinical Trials
467,251 Total Patients Enrolled
Troy MartinStudy ChairHVTN LOC, Fred Hutch
Michael Keefer, M.D.Study ChairUniv. of Rochester Med. Ctr., HVTU

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18-50 years old.
You agree to comply with study procedures and be available for follow-up through the last clinic visit.
You have two or more injection sites in the deltoid muscle of each arm.
You have a white blood cell count of 2,500-12,000/mm3.
You have a body mass index (BMI) of 40 or less.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.