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NCT05423418 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults
A Phase 1 study of Human Immunodeficiency Virus (HIV) and AIDS Virus, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05423418 is a Phase 1 study of Human Immunodeficiency Virus (HIV) and AIDS Virus that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 65 participants, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05423418, a Phase 1 study of Human Immunodeficiency Virus (HIV) and AIDS Virus, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimize vaccine adjuvant ALFQ dosing by assessing safety, reactogenicity, and immunogenicity. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Sixty human immunodeficiency virus (HIV) negative participants will be enrolled to one of three arms. Vaccinations via intramuscular (IM) injection will occur at months 0, 1, and 2. All participants will receive A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ.
Conditions Studied
Interventions
- BIOLOGICAL A244
- BIOLOGICAL B.63521
- BIOLOGICAL 50μg ALFQ
- BIOLOGICAL 100μg ALFQ
- BIOLOGICAL 200μg ALFQ
Study Locations (1)
Maryland
- Walter Reed Army Institute of Research, Clinical Trials Center - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-09-08 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05423418
The ClinicalTrials.gov registry entry for NCT05423418 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (87% lower). The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 5 interventions - of which A244 is the first listed.
NCT05423418 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05423418 about?
NCT05423418 is a clinical study titled "Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults". This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimi...
What is the current status of trial NCT05423418?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2022-09-08. Estimated completion is 2024-10-29.
What conditions does trial NCT05423418 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV), AIDS Virus.
What interventions are being tested in trial NCT05423418?
The interventions under investigation include: A244 (BIOLOGICAL), B.63521 (BIOLOGICAL), 50μg ALFQ (BIOLOGICAL), 100μg ALFQ (BIOLOGICAL), 200μg ALFQ (BIOLOGICAL).
Who is sponsoring clinical trial NCT05423418?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05423418 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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