BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted / GSK, IAVI - LARVOL DELTA

Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Jul 2025 ➔ May 2026 | Trial primary completion date: Jul 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: International AIDS Vaccine Initiative | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Trial to Evaluate the Safety and Immunogenicity of Priming Regimens of 426c.Mod.Core-C4b and Optional Boost Regimen With HIV Trimer BG505 SOSIP.GT1.1 gp140, Both Adjuvanted With 3M-052-AF + Alum in Healthy, Adult Participants Without HIV (clinicaltrials.gov) - P1 | N=52 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Aug 2024 ➔ Jul 2025 | Trial primary completion date: Sep 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted (clinicaltrials.gov) - P1 | N=8 | Enrolling by invitation | Sponsor: International AIDS Vaccine Initiative | Not yet recruiting ➔ Enrolling by invitation | Initiation date: Nov 2023 ➔ Apr 2024 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Enrollment open • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Safety Profile and Immunogenicity of a Phase I Clinical Trial Using Germline-Targeting Trimer GT1.1 (CROI 2024) - "Pre-clinical studies have shown the ability of the BG505 SOSIP.GT1.1 gp140 (GT1.1) vaccine to prime bNAb precursor B cells, including those targeting the CD4-binding site...The adjuvanted GT1.1 vaccine has an acceptable safety and reactogenicity profile and induced a potent vaccine-specific serum antibody response. Here, a higher GT1.1 dose induced a more rapid and robust serum antibody binding response without compromising safety. Thus, germline-targeting trimer GT1.1 may represent a promising vaccine candidate for priming bNAb responses in humans."

Clinical • P1 data • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Evaluate the Safety and Immunogenicity of 2 Doses of 100µg BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, Given to a Population of Adults Who Have Received 3 Doses of 300µg BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: International AIDS Vaccine Initiative

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial to Evaluate the Safety and Immunogenicity of a Prophylactic HIV Vaccine Candidate (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: International AIDS Vaccine Initiative

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected Adults (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: International AIDS Vaccine Initiative | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ Dec 2023 | Trial primary completion date: May 2021 ➔ Aug 2023

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease