NCT05423418

Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults

A Phase 1 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of ALFQ Adjuvant in a Candidate HIV Vaccine Containing A244 and B.65321

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this Phase I randomized, double-blind clinical trial is to optimize ALFQ dosing. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood will be collected to assess humoral, cell-mediated, and innate immune responses. Healthy adults not living with HIV who are available for 14 months will be enrolled. A total of 60 participants will be enrolled to one of three arms, each comprised of 20 candidate vaccine recipients. Each arm will receive identical doses of 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. The safety, reactogenicity, and immunogenicity will then be compared among the three arms to determine the optimal dose of ALFQ. All vaccinations will be split into 2 half doses which will both be administered intramuscularly (IM) into the same deltoid muscle. Vaccinations will occur at months 0, 1, and 2. The second vaccination will be administered into the contralateral deltoid at study month 1 compared to the first vaccination at study month 0. The third vaccination at study month 2 will be administered into the same deltoid as the first vaccination at study month 0. Participants will be followed for 12 months following the last study vaccination. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Vaccine- related reactions will be observed and solicited for 30 minutes post-vaccination and with the aid of a diary card and interview of participants during the 14 days post vaccination. The information gained from the review of the diary card and the interview with the participants will be documented in the clinical study chart. In addition, adverse events (AEs) will be documented at each clinical encounter. AEs will be graded for seriousness, severity, and relationship to the investigational product.

Conditions

• Human Immunodeficiency Virus (HIV)
• AIDS Virus

Interventions

Type	Name	Description
BIOLOGICAL	A244	Dose of A244 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
BIOLOGICAL	B.63521	Dose of B.63521 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
BIOLOGICAL	50μg ALFQ	Dose of ALFQ is 50μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
BIOLOGICAL	100μg ALFQ	Dose of ALFQ is 100μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
BIOLOGICAL	200μg ALFQ	Dose of ALFQ is 200μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).

Timeline

• Start date: 2022-09-08
• Primary completion: 2024-10-29
• Completion: 2024-10-29
• First posted: 2022-06-21
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study