A244/B.63521 + 200 μg of ALFQ adjuvant for Acquired Immunodeficiency Syndrome (AIDS) Virus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Walter Reed Army Institute of Research, Clinical Trials Center, Silver Spring, MD
Acquired Immunodeficiency Syndrome (AIDS) Virus+3 More
A244 - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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.

Eligible Conditions

  • Acquired Immunodeficiency Syndrome (AIDS) Virus
  • Human Immunodeficiency Virus (HIV) Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acquired Immunodeficiency Syndrome (AIDS) Virus

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Days 0 to 393

Day 0 to 336
Number of Participants with HIV-specific Binding Antibodies
Day 0
Number of Participants with Local and Systemic Reactions
Days 0 to 393
Incidence of Adverse Events (AEs), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and unsolicited AEs

Trial Safety

Safety Progress

1 of 3

Other trials for Acquired Immunodeficiency Syndrome (AIDS) Virus

Trial Design

3 Treatment Groups

A244/B.63521 + 200 μg of ALFQ adjuvant
1 of 3
A244/B.63521 + 50 μg of ALFQ adjuvant
1 of 3
A244/B.63521 + 100 μg of ALFQ adjuvant
1 of 3
Active Control

60 Total Participants · 3 Treatment Groups

Primary Treatment: A244/B.63521 + 200 μg of ALFQ adjuvant · No Placebo Group · Phase 1

A244/B.63521 + 200 μg of ALFQ adjuvantActiveComparator Group · 3 Interventions: A244, B.63521, 200μg ALFQ · Intervention Types: Biological, Biological, Biological
A244/B.63521 + 50 μg of ALFQ adjuvantActiveComparator Group · 3 Interventions: A244, B.63521, 50μg ALFQ · Intervention Types: Biological, Biological, Biological
A244/B.63521 + 100 μg of ALFQ adjuvantActiveComparator Group · 3 Interventions: A244, B.63521, 100μg ALFQ · Intervention Types: Biological, Biological, Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: days 0 to 393
Closest Location: Walter Reed Army Institute of Research, Clinical Trials Center · Silver Spring, MD
2007First Recorded Clinical Trial
1 TrialsResearching Acquired Immunodeficiency Syndrome (AIDS) Virus
3 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a healthy adult between the ages of 18-55 years (inclusive).
You are at low risk for HIV infection.
You are able and willing to comply with all research requirements, in the opinion of the Investigator Agreement to refrain from blood donation during the course of the study.
You weigh at least 110 pounds (lbs).
You have a hemoglobin level of 12.0 g/dL or higher for women and 12.
You have a white blood cell count between 3,500 and 10,800 cells/mm3.
Platelets ≥ 140,000/mm3 and ≤ 450,000/mm3.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References