HIVconsvX / University of Oxford - LARVOL DELTA

Safety of a ChAdOx1.tHIVconsvX prime - MVA.tHIVconsvX boost vaccination regimen in people with HIV treated in primary infection: a phase I/II randomized, placebo-controlled trial (HIV-CORE 007) (EACS 2025) - P1/2 | "Conclusions : The prime-boost vaccination regimen was safe in PLWH. An analytical treatment interruption to test viral control is ongoing."

Clinical • P1/2 data • Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

Luciferase-based viral inhibition assay demonstrates ChAdOx1–MVA HIVconsvX vaccine elicits functional HIV-1 specific CD8+ T cells capable of inhibiting replication of a diverse panel of HIV-1 isolates (IAS-HIV 2025) - P1 | "The ChAdOx1–MVA HIVconsvX vaccine candidate induces functional HIV-1 specific CD8+ T-cell responses capable of inhibiting HIV-1 replication in vitro. These CD8+ T-cell effectors inhibited HIV-1 IMCs originating from diverse geographical regions, types (founder/transmitter vs lab-adapted) and tropisms (CCR5 vs CXCR4). The luciferase-based VIA provides a valuable tool for evaluating the potential efficacy of HIV-1 vaccines in inducing protective CD8+ T-cells, thereby informing on further vaccine development and testing."

Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8 • CXCR4

Development and characterization of a novel HIV vaccine candidate using SpyTag/SpyCatcher technology to decorate virus-like particles displaying native-like Env trimers (IAS-HIV 2025) - "This study provides a promising approach for HIV vaccine design by combining the immunogenicity of VLPs with the structural integrity of native-like Env trimers. This novel HIV vaccine candidate using SpyTag/SpyCatcher technology to coat virus-like particles displaying native-like Env trimers will be co-administered with the T-cell HIVconsvX vaccine candidate for induction of combined antibody and killer T-cell immune responses."

Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Safety and broad immunogenicity of HIVconsvX conserved mosaic candidate T-cell vaccines vectored by ChAdOx1 and MVA in HIV-CORE 006: a double-blind, randomised, placebo-controlled phase 1 trial in healthy adults living without HIV-1 in eastern and southern Africa. (PubMed, Lancet Microbe) - P1 | "Results from key sub-Saharan African populations supported the safety of the vaccine regimen previously shown in the first-in-human trial in the UK. The induction of T cells and their characteristics encourage vaccine integration into HIV-1 cure strategies, which could inform HIV-1 prevention efforts."

Journal • P1 data • Human Immunodeficiency Virus • Infectious Disease • IFNG

Age Inversely Correlates With T-Cell Response to MVA.HIVconsvX Vaccination in PWH on ART (CROI 2025) - "However, the strength of the T cell response to vaccination exhibited an inverse and linear association with age. Novel approaches are needed to improve HIV immunity in middle- to older-aged PWH."

Human Immunodeficiency Virus • Infectious Disease • CD4 • CD8

ChAdOx1.HIVconsvX and MVA.HIVconsvX Vaccination Is Safe and Immunogenic in PWH on ART: The CM Study (CROI 2025) - "Exclusion criteria included history of clotting disorders and prior vaccination with MVA-mpox and ChAdOx1 nCoV-19 vaccines...Conclusions We present the first results following vaccination with C62-M4 and C1C62-M3M4 in PWH on ART. Vaccination was safe and immunogenic. Analysis of unblinded safety and immunogenicity data for all study participants will be presented."

Human Immunodeficiency Virus • Infectious Disease • IFNG

Safety and immunogenicity of the ChAdOx1-MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK. (PubMed, Lancet Microbe) - P1 | "These results inform and support a programme of clinical evaluations of the HIVconsvX T-cell vaccines together with other cutting-edge tools for HIV-1 cure and prevention such as latency reactivating agents, passively infused combinations of broadly neutralising antibodies, and active Env-based vaccines or immunomodulators."

Journal • P1 data • Human Immunodeficiency Virus • Infectious Disease • IFNG

Combined intranasal and intramuscular parainfluenza 5-, simian adenovirus ChAdOx1- and poxvirus MVA-vectored vaccines induce synergistically HIV-1-specific T cells in the mucosa. (PubMed, Front Immunol) - "We showed in BALB/c mice that the PIV5 vector expressing the HIVconsvX immunogens could be readily incorporated with the other two vaccine modalities into a single regimen and that for specific vector combinations, mucosal CD8 T-cell induction was enhanced synergistically by a combination of the intranasal and intramuscular routes of administration. Encouraging safety and immunogenicity data from phase 1 human trials of ChAdOx1- and MVA-vectored vaccines for HIV-1, and PIV5-vectored vaccines for SARS-CoV-2 and respiratory syncytial virus pave the way for combining these vectors for HIV-1 and other indications in humans."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD8

Adenovirus Transcriptome in Human Cells Infected with ChAdOx1-Vectored Candidate HIV-1 Vaccine Is Dominated by High Levels of Correctly Spliced HIVconsv1&62 Transgene RNA. (PubMed, Vaccines (Basel)) - "Our two main observations in nonpermissive human cells, which are most similar to those which become infected after the intramuscular administration of vaccines into human volunteers, were that (i) the dominant adenovirus vector-derived mRNAs were the expected transcripts coding for the HIVconsvX immunogens and (ii) atypical splicing events within the synthetic open reading frame of the two transgenes are rare. We conclude that inadvertent RNA splicing is not a safety concern for the two tested candidate HIV-1 vaccines."

Journal • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Broad HIV-1 inhibition elicited by human data-driven HIVconsvX conserved T-cell vaccines vectored by ChAdOx1 and MVA in HIV-CORE 005.2: an open-label, non-randomized, dose-escalation, first-in-man phase 1 trial (IAS-HIV 2023) - "These data support a program of clinical evaluations in prevention and cure of the vaccine strategy alone and in combination with active induction or passive infusion of broadly neutralizing antibodies and/or drugs affecting HIV-1 latent reservoir, which will be presented."

Clinical • Late-breaking abstract • P1 data • Human Immunodeficiency Virus • Infectious Disease • IFNG

A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: University of Oxford | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • IFNG

M&M: Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: University of North Carolina, Chapel Hill | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

Strong Immunogenicity of Conserved Mosaic T-cell Vaccines HIV consvX in HIV-negative Subjects in the UK and Africa (VACCINES SUMMIT 2022) - No abstract available

Clinical • Human Immunodeficiency Virus • Infectious Disease