A phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV-1 envelope protein ConM SOSIP.v7 gp140 vaccine, adjuvanted with MPLA liposomes, in healthy, HIV-uninfected Adults

The single centre, randomised, open-label, uncontrolled, phase 1 ACTHIVE-001 clinical trial (NCT03961438) aims to assess the safety and immunogenicity of the ConM SOSIP.v7 native-like trimer protein vaccine, based on an HIV-1 group M consensus sequence, in HIV-negative adults. Twenty-four individuals have enrolled to receive three dosages of ConM SOSIP.v7 protein vaccine in a liposome formulation containing a high dose of the TLR4-agonist MPLA. The primary outcome is vaccine reactogenicity, whereas the main secondary outcome is binding and neutralising antibody responses. Post-hoc exploratory analyses demonstrate that female born participants have 22- and 6-fold higher neutralisation titres after the second and third vaccination, respectively. As isolated broadly neutralising antibodies (bNAbs) from people living with HIV often display extensive somatic hypermutation (SHM), this was assessed as a potential underlying factor. To assess SHM levels in BCR sequences of memory B cells, we performed high-throughput single-cell sequencing (10X Genomics®) post-immunisation at 26 and 48 weeks. The experiment was performed in 2 separate 10X chips, 4 lanes total with three libraries: GEX, ADT, and BCR. The three libraries are uploaded separately for the first sample of every lane. Linked samples are uploaded as sample pool containing all samples included in that run. Sample description includes individual sample names and descriptions including the barcode used for multiplexing.