Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05854381 · ClinicalTrials.gov registry record · Phase 1
To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV
A Phase 1 study of HIV I Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 10
- Study locations
NCT05854381: Completed Phase 1 study of HIV I Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05854381 is a Phase 1 study of HIV I Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 93 participants, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05854381, a Phase 1 study of HIV I Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
Primary Outcome
Events will be graded as per the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VIR-1388
Study Locations (10)
Pennsylvania
- Penn Prevention CRS - Philadelphia
- University of Pittsburgh CRS - Pittsburgh
Gauteng
- Setshaba Research Centre CRS - Soshanguve
- Perinatal HIV Research Unit - Soweto
KwaZulu-Natal
- Isipingo Clinical Research Site - Isipingo
- Chatsworth Clinical Research Site - Overport
Alabama
- Alabama CRS - Birmingham
Georgia
- The Hope Clinic of the Emory Vaccine Center CRS - Decatur
Massachusetts
- Beth Israel Deconess Medical Center VCRS - Boston
Washington
- Seattle Vaccine and Prevention CRS - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2023-09-19 |
| Est. Completion | 2025-11-19 |
| Phase | Phase 1 |
What the finished NCT05854381 record still lists
NCT05854381 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower).
The record links to 1 condition, with HIV I Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05854381 lists 10 locations in 7 states (Pennsylvania, Gauteng, KwaZulu-Natal).
Frequently Asked Questions
What is clinical trial NCT05854381 about?
NCT05854381 is a clinical study titled "To Investigate Safety, Reactogenicity and Immunogenicity of VIR-1388 Compared With Placebo in Participants Without HIV". The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of VIR 1388 in adults in good health without HIV.
What is the current status of trial NCT05854381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2023-09-19. Estimated completion is 2025-11-19.
What conditions does trial NCT05854381 study?
This clinical trial studies the following conditions: HIV I Infection.
What interventions are being tested in trial NCT05854381?
The interventions under investigation include: Placebo (BIOLOGICAL), VIR-1388 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05854381?
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 NCT05854381 being conducted?
This trial has 10 study locations across Alabama, Georgia, Massachusetts, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV I Infection
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.
-
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
COMPLETED · Phase 1
-
Intervention to Improve HIV Care Retention by Addressing Stigma Stigmatized Environments
ACTIVE NOT RECRUITING · NA
-
Charlotte Retention in Care Study
COMPLETED
-
Acute Effects of TCIG vs ECIG in PLWH
COMPLETED · NA
-
Estradiol Therapy In Transgender Women to Research Interactions With HIV Therapy
COMPLETED · Phase 2
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
- NCT02203526 · 93 participants · Phase 1
Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma
- NCT03089554 · 93 participants · Phase 2
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
- NCT05000021 · 93 participants · NA
Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes
- NCT05489887 · 93 participants · Phase 2
Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
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