Johnson & Johnson today announced that The Lancet has published key early-stage data regarding a mosaic-based, investigational HIV-1 vaccine in development at its Janssen Pharmaceutical Companies.
In the Phase 1/2a APPROACH study, based on the data generated, the mosaic vaccine 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 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 vaccine into its first large-scale efficacy study.
‘These are promising but still early-stage results. At 52 weeks, we observed that the mosaic HIV vaccine induced robust and comparable immune responses to HIV in humans and in nonhuman primates, and the vaccine protected against infection with an HIV-like virus in nonhuman primates,’ said Professor Dan Barouch, Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and a lead author of The Lancet paper.
Janssen’s investigational mosaic-based vaccine regimen contains immunogens created using genes from different viral subtypes responsible for HIV infections worldwide.
‘The progress made in the last thirty years in the fight against HIV is remarkable, yet HIV still persists as a global health threat affecting millions,’ said Paul Stoffels, MD, Executive Vice President, Chief Scientific Officer, Johnson & Johnson. ‘The genetic diversity inherent in HIV brings many challenges, but we are committed to developing a ‘global vaccine’ effective against the multiple strains of the virus. Our quest is to develop a vaccine that would put an end to the worldwide pandemic for good.’
In addition to the results reported in The Lancet, the first long-term immunological data from the APPROACH study will be presented in an oral presentation at the 22nd International AIDS Conference (AIDS 2018) on Tuesday, July 24, 2018 in Amsterdam, The Netherlands. This presentation has also been selected for inclusion in the official press program of the conference.
Based on results from APPROACH and other early-stage studies, in November 2017Janssen and its global partners initiated the first efficacy study for a mosaic-based vaccine regimen. The Phase 2b 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 Imbokodo are expected in 2021.
Although great progress has been made in the fight against AIDS, a safe and effective vaccine will likely be required to truly end the HIV pandemic. In 2016, nearly 37 million people were living with HIV globally, 1.8 million people were newly infected with HIV, and 1 million people died of AIDS.[i]
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