Study: NCT05182125

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdC7-HIVgp140
Description: The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles.~AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation.~The study product is described in further detail in the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdC7-HIVgp140
Description: The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles.~AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation.~The study product is described in further detail in the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AdC7-HIVgp140
Description: The products is diluted in 2.5% Glycerol/25 mM NaCl/20 mM TRIS \[tris(hydroxymethyl)aminomethane\], pH 8.0 formulation buffer to a concentration of 1.2 x 10\^11 vp/mL and filled at 0.6 mL for AdC7-HIVgp140 into a 2 mL Type 1 glass vial and stoppered with a gray chlorobutyl rubber stopper. The product is clear to slightly cloudy liquid, essentially free of visible particles.~AdC7-HIVgp140 should be stored at ≤ -65°C prior to use/preparation.~The study product is described in further detail in the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CH505TF gp120
Description: CH505TF gp120 is formulated in 20 mM sodium phosphate, 150 mM NaCl, 0.02% polysorbate 80 (PS80), pH 6.5, supplied as a frozen liquid in 2 mL glass vials. Each 2 mL vial contains 0.75 mL of formulated gp120 at a concentration of 0.8 mg/mL and is stored at ≤ -65°C.~The study product is described in further detail in the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: CH505TF gp120
Description: CH505TF gp120 is formulated in 20 mM sodium phosphate, 150 mM NaCl, 0.02% polysorbate 80 (PS80), pH 6.5, supplied as a frozen liquid in 2 mL glass vials. Each 2 mL vial contains 0.75 mL of formulated gp120 at a concentration of 0.8 mg/mL and is stored at ≤ -65°C.~The study product is described in further detail in the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])
Description: The GLA-SE adjuvant will be provided as vials containing 20 mcg/mL GLA in a 4% oil-in-water emulsion. Each sterile, single use vial contains 0.4 mL of product. Product appears as a milky-white liquid. GLA-SE must be stored at 2° to 8°C and must not be frozen. The study product is described in further detail within the IB.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GLA-SE (glucopyranosyl lipid A - stable emulsion; [labeled as AP 10-201])
Description: The GLA-SE adjuvant will be provided as vials containing 20 mcg/mL GLA in a 4% oil-in-water emulsion. Each sterile, single use vial contains 0.4 mL of product. Product appears as a milky-white liquid. GLA-SE must be stored at 2° to 8°C and must not be frozen. The study product is described in further detail within the IB.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer.

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo will be Sodium Chloride for Injection, 0.9%, will be used as the placebo. It must be stored as recommended by the manufacturer.