GTU-multi-HIV B clade DNA vaccine / FIT Biotech, ValiRx - LARVOL DELTA

WHICH ENDPOINT TO CHOOSE DURING ANTIRETROVIRAL TREATMENT INTERRUPTION? (CROI 2023) - "The VRI02 ANRS 149 LIGHT is a phase 2 trial of 103 patients randomized to either recombinant DNA vaccine (GTU-MultiHIV B) followed by lipopeptide vaccine (HIV-LIPO-5) or placebo and followed during a 12-week ATI period... The evaluation of time to rebound requires frequent monitoring of HIV RNA (at least once a week over 6 weeks) and does not reflect at all the viral setpoint in case of viral replication. For the evaluation of the capacity to control viral replication, we recommend to use of the AUC where ART are resumed if HIV RNA goes above 5 log10 copies/mL."

Human Immunodeficiency Virus • Infectious Disease • IL2

T Cell Immunogenicity, Gene Expression Profile, and Safety of Four Heterologous Prime-Boost Combinations of HIV Vaccine Candidates in Healthy Volunteers: Results of the Randomized Multi-Arm Phase I/II ANRS VRI01 Trial. (PubMed, J Immunol) - "In this phase I/II multi-arm trial, three vaccine candidates were used as prime or boost: modified vaccinia Ankara (MVA) HIV-B (coding for Gag, Pol, Nef); HIV LIPO-5 (five lipopeptides from Gag, Pol, Nef); DNA GTU-MultiHIV B (coding for Rev, Nef, Tat, Gag, Env gp160 clade B)...An MVA gene signature was identified, including 86 genes mainly related to cell cycle pathways. Three prime-boost strategies led to CD4 and CD8 T cell responses and to a whole-blood gene expression signature primarily due to their MVA HIV-B component."

Journal • P1/2 data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • IFNG • IL2 • TNFA

A randomized placebo-controlled efficacy study of a prime boost therapeutic vaccination strategy in HIV-1 infected individuals: VRI02 ANRS 149 LIGHT Phase II trial. (PubMed, J Virol) - "In this placebo-controlled phase II randomized clinical trial, 103 HIV-1 infected patients under c-ART (combined antiretroviral treatment) were randomized 2:1 to receive 3 doses of DNA GTU-MultiHIV B (coding for Rev, Nef, Tat, Gag and gp160) at Week (W)0, W4 and W12 followed by 2 doses of LIPO-5 vaccine containing long peptides from Gag, Pol and Nef at W20 and W24 or placebos...However, these immune responses presenting some qualitative defects were not able to control viremia following antiretroviral treatment interruption as no difference in HIV viral rebound was observed in vaccine and placebo groups. Several lessons were learned from these results pointing out the urgent need to combine the vaccine strategies with other immune-based interventions."

Clinical • IO biomarker • Journal • P2 data • Human Immunodeficiency Virus • Immune Modulation • Infectious Disease • Inflammation

The Safety and Immunogenicity of GTUMultiHIV DNA Vaccine Delivered by Transcutaneous and Intramuscular Injection With or Without Electroporation in HIV-1 Positive Subjects on Suppressive ART. (PubMed, Front Immunol) - P1/2 | "These data suggest that more potent prime-boost vaccination strategies are likely needed to improve pre-existing responses in similar HIV-1 cohorts (This study has been registered at http://ClinicalTrials.gov under registration no. NCT02457689)."

Clinical • Journal • Gene Therapies • Human Immunodeficiency Virus • Infectious Disease