NCT04658667

HIV Vaccine in HIV-uninfected Adults

Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test whether delayed boosting (an extra administration of a vaccine) with the IHV01 (FLSC) protein and A244/AHFG with or without ALFQ will cause the body to make higher amounts of antibodies or different types of antibodies after the vaccination.

Detailed description

The purpose of this study is to define the safety and immunogenicity of IHV01 and A244/AHFG with and without ALFQ at a full dose and at a fractional dose (one-fifth of a full dose) in a late boost setting for participants who had previously received a late boost of AIDSVAX®B/E with or without ALVAC in RV306. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood, lymph nodes, sigmoid tissue, and mucosal specimens/secretions will be collected to assess humoral, cell-mediated, innate, and mucosal immune responses. Healthy, HIV-uninfected participants, at a low risk for HIV infection, available for 12 months, who were randomized to receive active vaccine in RV306 and completed all vaccinations will be enrolled. A total of 120 participants will be enrolled across four vaccination groups. In each group, 25 participants will receive IHV01 and A244/AHFG at a full or fractional dose with or without ALFQ and 5 participants will receive placebo. Participants will receive 2 intramuscular (IM) injections into the quadriceps muscle at Day 0. The same quadriceps muscle will be used for both injections. Participants randomized to receive the vaccines will have one injection of IHV01 and one injection of A244/AHFG at a full or fractional dose with or without ALFQ, whereas participants randomized to receive placebo will get 2 separate injections of Normal Saline. All placebo injection volumes will match the vaccine injection volumes for the group in which a participant has been randomized. Participants will be followed-up for up to 12 months after enrollment. Mucosal secretion collections and endocervical cytobrush/swab procedures will be performed at Days 0, 14, 168, and 336 on consenting participants. Leukapheresis, sigmoid biopsy, and lymph node biopsy procedures will be performed only at Day 14 on consenting participants.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	IHV01	IHV01 consists of the Full-Length Single Chain (FLSC) gp120-CD4 chimera subunit HIV-1 vaccine formulated in aluminum phosphate adjuvant. It is encoded by a synthetic gene, which contains a human codon-optimized HIV (BaL) gp120 sequence followed by human CD4D1D2, with a flexible 20-amino acid linker.
BIOLOGICAL	A244	A244 consists of the gp120 envelope glycoprotein HIV-1 subtype CRF\_01AE A244 derived from the CM244 CRF\_01AE. The A244 gp120 envelope has an 11 amino N-terminal deletion, similar to the A244 protein used in AIDSVAX B/E. The aluminum hydroxide fluid gel (AHFG) adjuvant that is mixed with A244 consists of Rehydragel HPA that is diluted with sterile water for injection to a concentration of 5 + /- 1mg/mL.
BIOLOGICAL	ALFQ	ALFQ (Army Liposomal Formulation) is a liposomal adjuvant containing a synthetic monophosphoryl lipid A (MPLA) with the addition of QS-21.
OTHER	Placebo	Normal saline (Sodium Chloride for injection USP, 0.9%) will be used as placebo.

Timeline

• Start date: 2022-02-03
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2020-12-08
• Last updated: 2025-07-30

Locations

2 sites across 1 country: Thailand

Regulatory

• FDA-regulated drug study