The Lancet has published key early-stage data regarding an investigational mosaic-based preventive vaccine regimen against HIV-1 infection .- Janssen Pharmaceutical companies.
Johnson & Johnson today announced that The Lancet has published key early-stage data regarding an investigational mosaic-based preventive vaccine regimen against HIV-1 infection that is in development at its Janssen Pharmaceutical Companies. In the Phase 1/IIa APPROACH study, based on the data generated, the vaccine regimen was safe and well-tolerated and elicited a robust HIV antibody response in all healthy volunteers receiving active vaccine. Additionally, in a parallel study in non-human primates (NHPs), the most immunogenic mosaic-based vaccine regimen in humans demonstrated similar immune responses in NHPs and afforded 67% protection against an HIV-like virus.
The Lancet paper provides the first detailed analysis of topline results presented by Janssen at the 9th IAS Conference on HIV Science (IAS 2017) in July 2017, and supports the recent advancement of the mosaic-based vaccine regimen into its first large-scale efficacy study.
Based on results from APPROACH and other early-stage studies, in November 2017 Janssen and its global partners initiated the first efficacy study for a mosaic-based vaccine regimen. The Phase IIb trial, HVTN 705/HPX2008 (also known as �Imbokodo�), aims to enroll 2,600 young women aged 18-35 in five sub-Saharan African countries to see whether the vaccine is safe and able to reduce HIV infection in this at-risk population. Participants are now enrolling at clinical research sites in South Africa, Zimbabwe and Malawi. The study has been cleared to start in Zambia, and regulatory approval is pending in Mozambique. Results from HVTN 705/ HPX2008 are expected in 2021.
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