Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05903339 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
A Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT05903339: Active Phase 1 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05903339 is a Phase 1 study of HIV that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 36 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05903339, a Phase 1 study of HIV, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.
Primary Outcome
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Conditions Studied
Interventions
- DRUG V3G CH848 Pr-NP1 60mcg
- DRUG 3M-052-AF 5mcg
- DRUG Alum 500 mcg
- DRUG V3G CH848 mRNA-Tr2 50mcg
- DRUG ACU-026-001-1 2.0mg
Study Locations (6)
Massachusetts
- Brigham & Women's Hospital [Site ID: 30007] - Boston
- BIDMC VCRS [Site ID: 32077] - Boston
Alabama
- Alabama CRS [Site ID: 31788] - Birmingham
Georgia
- Emory University School of Medicine, The Ponce de Leon Center CRS [Site ID: 5802] - Atlanta
Tennessee
- Vanderbilt Vaccine (VV) CRS [Site ID: 30352] - Nashville
Washington
- Seattle Vaccine and Prevention CRS [Site ID: 30331] - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-08-29 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
What the registry record for NCT05903339 still lists
NCT05903339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which V3G CH848 Pr-NP1 60mcg is the first listed.
NCT05903339 lists 6 locations in 5 states (Massachusetts, Alabama, Georgia).
Frequently Asked Questions
What is clinical trial NCT05903339 about?
NCT05903339 is a clinical study titled "Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV". This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This...
What is the current status of trial NCT05903339?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2023-08-29. Estimated completion is 2026-10-30.
What conditions does trial NCT05903339 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT05903339?
The interventions under investigation include: V3G CH848 Pr-NP1 60mcg (DRUG), 3M-052-AF 5mcg (DRUG), Alum 500 mcg (DRUG), V3G CH848 mRNA-Tr2 50mcg (DRUG), ACU-026-001-1 2.0mg (DRUG).
Who is sponsoring clinical trial NCT05903339?
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 NCT05903339 being conducted?
This trial has 6 study locations across Alabama, Georgia, Massachusetts, Tennessee, Washington. 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 NCT05903339's enrollment target sits among peer trials
36 251st of 303 higher than 51 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
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
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