Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Human Immunodeficiency Virus (HIV) and AIDS Virus, sponsored by U.S. Army Medical Research and Development Command.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants with AEs, SAEs, AESIs, and unsolicited AEs on Day 0 through Day 337 as assessed by the Division of AIDS (DAIDS) grading scale and possible attribution to Investigational Product. The number of participants with medically attended AE will be followed until Day 393.
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 |
What the finished NCT05423418 record still lists
NCT05423418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 505-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus (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 NCT05423418's enrollment target sits among peer trials
65 12th of 18 higher than 7 of 18 other Human Immunodeficiency Virus (HIV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus (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
-
A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children
COMPLETED · Phase 1
-
A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)
COMPLETED · Phase 1
-
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
COMPLETED · Phase 1
-
Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)
COMPLETED · Phase 1
-
Persuasive Health Communication Intervention for HIV/HCV
RECRUITING · NA
-
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
RECRUITING · NA
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
- NCT03366116 · 65 participants · Phase 1
5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors
- NCT03603730 · 65 participants · NA
Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis
- NCT03796559 · 65 participants · NA
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
- NCT03993106 · 65 participants · Phase 2
A Study of sEphB4-HSA in Kaposi Sarcoma
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