gp145 C.6980 vaccine / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Co-administration of liposomal adjuvant ALF43 along with HIV-1 DNA vaccination improves binding antibody responses against HIV-1 (IAS-HIV 2025) - "Participants were primed with plasmid DNA (encoding HIV Env-C gp120) at weeks 0, 4, 12, either given intramuscularly (IM) alone (groups 1+2), combined with dmLT by skin patch (groups 3+4), combined with ALF43 IM (groups 5+6), or combined with HIV Env gp145 C.6980 protein+ALF43 IM (group 7)... ALF43 adjuvant improves DNA priming of this HIV Env vaccine; however, all vaccine/adjuvant combinations attained similar peak antibody titers post-boost. ALF43 in the DNA prime contributed to higher bAb durability."

Clinical • Late-breaking abstract • Human Immunodeficiency Virus • Infectious Disease • CD4

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya (clinicaltrials.gov) - P1 | N=126 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Feb 2024

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

Safety and immunogenicity of a recombinant oligomeric gp145 subtype C Env protein (gp145 C.6980) HIV vaccine candidate in healthy, HIV-1-uninfected adult participants in the US. (PubMed, Vaccine) - P1 | "Three doses of novel subtype C gp145 Env protein with alum were safe and well-tolerated. Participants demonstrated bAb, Env-specific CD4 + T-cell, and tier 1 nAb responses, but the regimen failed to induce tier 2 or heterologous nAb responses."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pruritus • CD4 • CD8

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya (clinicaltrials.gov) - P1 | N=126 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Feb 2023 ➔ Oct 2024 | Trial primary completion date: Feb 2023 ➔ Jan 2024

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

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya (clinicaltrials.gov) - P1 | N=126 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya (clinicaltrials.gov) - P1; N=126; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United States (clinicaltrials.gov) - P1; N=45; Completed; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Completed

Clinical • Trial completion