MVHTI immunogen / Aelix Therap - LARVOL DELTA

Safety, immunogenicity and effect on viral rebound of HTI vaccines in early treated HIV-1 infection: a randomized, placebo-controlled phase 1 trial. (PubMed, Nat Med) - P1 | "The AELIX-002 trial was a randomized, placebo-controlled trial to evaluate as a primary objective the safety of a combination of DNA.HTI (D), MVA.HTI (M) and ChAdOx1.HTI (C) vaccines in 45 early-antiretroviral (ART)-treated individuals (44 men, 1 woman; NCT03204617). Plasma viral load at the end of ATI and time off ART positively correlated with vaccine-induced HTI-specific T-cell responses at ART cessation. Despite limited efficacy of the vaccines in preventing viral rebound, their ability to elicit robust T-cell responses towards HTI may be beneficial in combination cure strategies, which are currently being tested in clinical trials."

Journal • P1 data • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD4 • CD8

Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study) (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study) (clinicaltrials.gov) - P1; N=6; Active, not recruiting; Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia; N=40 ➔ 6; Trial completion date: Jun 2022 ➔ Feb 2022; Trial primary completion date: Jun 2022 ➔ Aug 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002) (clinicaltrials.gov) - P1; N=45; Completed; Sponsor: Aelix Therapeutics; Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

[VIRTUAL] A PLACEBO-CONTROLLED ATI TRIAL OF HTI VACCINES IN EARLY TREATED HIV INFECTION (CROI 2021) - P1, P2a | "Background: HTI is a novel HIV vaccine immunogen designed at redirecting cellular immune responses to HIV targets associated with viral control. The AELIX-002 trial (NCT03204617) was a randomized, singlecenter, placebo-controlled trial to evaluate the safety, immunogenicity and antiviral effect of DNA.HTI (D), MVA.HTI (M) and ChAdOx1.HTI (C) vaccines after discontinuation of ART in early-treated people living with HIV (PLWH)... HTI vaccines were safe and highly immunogenic in early-treated PLWH with a prolonged time off ART seen in vaccinees with non-beneficial HLA class I alleles. Time off ART positively correlated with vaccine-induced HTIspecific T cell responses at ATI start. Multivariate analysis for other correlates of response is ongoing."

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

Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study) (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

Safety and Immunogenicity Study of DNA.HTI, MVA.HTI and ChAdOx1.HTI in HIV-1-positive Patients (AELIX-002) (clinicaltrials.gov) - P1; N=45; Active, not recruiting; Sponsor: Aelix Therapeutics; Trial completion date: Sep 2020 ➔ Mar 2021; Trial primary completion date: Jan 2020 ➔ Jul 2020

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

Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study) (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Fundacio Lluita Contra la SIDA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease

Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study) (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Fundacio Lluita Contra la SIDA

Clinical • New P1 trial • Gene Therapies • Genetic Disorders • Human Immunodeficiency Virus • Infectious Disease