Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05470400 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 6
- Study locations
NCT05470400: Completed Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05470400 is a Phase 1 study of HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 44 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05470400, a Phase 1 study of HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Conditions Studied
Interventions
- BIOLOGICAL FP conjugate vaccine (25 mcg)
- BIOLOGICAL FP conjugate vaccine (200 mcg)
- BIOLOGICAL Trimer 6931 (100 mcg)
- BIOLOGICAL Trimer 6931 (200 mcg)
- BIOLOGICAL Trimer 4571 (200 mcg)
Study Locations (6)
New York
- New York Blood Center CRS [31801] - New York
- Columbia P&S CRS [30329] - New York
- University of Rochester Vaccines to Prevent HIV Infection CRS [31467] - Rochester
Georgia
- Atlanta - Hope Clinic - Atlanta
Massachusetts
- BIDMC Vcrs [32077] - Boston
Pennsylvania
- University of Pittsburgh CRS [1001] - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-08-15 |
| Est. Completion | 2024-01-24 |
| Phase | Phase 1 |
What the finished NCT05470400 record still lists
NCT05470400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which FP conjugate vaccine (25 mcg) is the first listed.
NCT05470400 lists 6 locations in 4 states (New York, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05470400 about?
NCT05470400 is a clinical study titled "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". 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 wel...
What is the current status of trial NCT05470400?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2022-08-15. Estimated completion is 2024-01-24.
What conditions does trial NCT05470400 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT05470400?
The interventions under investigation include: FP conjugate vaccine (25 mcg) (BIOLOGICAL), FP conjugate vaccine (200 mcg) (BIOLOGICAL), Trimer 6931 (100 mcg) (BIOLOGICAL), Trimer 6931 (200 mcg) (BIOLOGICAL), Trimer 4571 (200 mcg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05470400?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05470400 being conducted?
This trial has 6 study locations across Georgia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05470400's enrollment target sits among peer trials
44 237th of 303 higher than 66 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
RECRUITING · Phase 1
-
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
RECRUITING · Phase 1
-
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
RECRUITING · Phase 1
-
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
RECRUITING · Phase 1
-
A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
ACTIVE NOT RECRUITING · Phase 1
-
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323945 · 44 participants · NA
Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
- NCT03093909 · 44 participants · Phase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
- NCT03104491 · 44 participants · Phase 1
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
- NCT03781765 · 44 participants · Phase 4
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI