The HIV vaccine pipeline thins out

The late-stage failure last week of Johnson & Johnson’s HIV vaccine candidate exposes just how sparse the pipeline is for prophylactic approaches, despite years of trying. The latest stumble, in the Mosaico study in men who have sex with men, came after 2021’s disappointment in the Imbokodo study in young women in sub-Saharan Africa. A look at the development landscape shows only a handful of projects in early-stage trials. And one of these could be set to disappoint: Vir Biotechnology disclosed last year that there had been no sustained T-cell responses in the first two dosing cohorts of a phase 1 study of VIR-1111. Data from the third and highest-dose cohort are due this half, but the company seems to have shifted attention to a next-gen candidate, VIR-1388, slated to enter the clinic later in 2023. Moderna also has two shots on goal with its mRNA candidates, in studies set to complete this year. The pipeline is rounded out by Worcester HIV Vaccine, which has a second-generation polyvalent DNA/protein HIV vaccine (PDPHV) project in phase 1. Companies like Gilead are looking to therapeutic vaccines as potential HIV cures, but a prophylactic now looks even further away.

Selected prophylactic HIV vaccines in clinical development
Project Company Description Note
Phase 3
Ad26.Mos4.HIV Johnson & Johnson Adenoviral vector vaccine + adjuvanted Clade C/Mosaic gp140 booster Mosaico in men/transgender people failed Jan 2023; Imbokodo in women failed Aug 2021
Phase 1
VIR-1111 Vir Biotechnology T-cell vaccine based on human cytomegalovirus NCT04725877; no HIV insert-specific T-cell responses in cohorts 1 & 2, cohort 3 data due H1 2023
mRNA-1644 Moderna mRNA vaccine NCT05001373 & NCT05414786 complete Apr & Jun 2023*
mRNA-1574 Moderna Trimer mRNA vaccine NCT05217641 completes Jul 2023**
PDPHV201401 Worcester HIV Vaccine Polyvalent DNA-prime/protein-boost vaccine NCT04927585 completes Dec 2023
*Sponsored by International AIDS Vaccine Initiative (IAVI); **sponsored by NIAID. Source: Evaluate Pharma &

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