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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 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.

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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.

Conditions Studied

HIV I Infection

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

FieldValue
Enrollment Target 93 participants
Start Date 2023-09-19
Est. Completion 2025-11-19
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT05854381

The ClinicalTrials.gov registry entry for NCT05854381 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,086-participant average among 5 other HIV I Infection trials with a reported enrollment target (96% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.