GSK statement: Trial planned for new HIV vaccine regimen

Thursday 19 May 2016

GSK welcomes the news from the USA’s National Institute of Allergy and Infectious Diseases (NIAID)and the P5 partnership that it will be moving an investigational HIV vaccine into a large scale phase IIB/III clinical trial in South Africa later this year, assuming approval from regulatory authorities. Vaccine development takes a long time, however we believe this is a positive development in the search for a vaccine to prevent HIV infections.

The clinical trial, which is the only currently planned efficacy trial of an HIV vaccine in Southern Africa, will take several years to complete, including 3 years of follow-up of the 5,400 volunteers.

The P5 (Pox-Protein Public-Private Partnership) collaboration is made up of a diverse group of organizations including GSK along with NIAID, the Division of AIDS (DAIDS), Fred Hutchison Cancer Research Center/HIV Vaccine Trials Network (FHCRC/HVTN), Bill & Melinda Gates Foundation (BMGF) and Sanofi Pasteur. The trial is sponsored by the Division of AIDS (DAIDS), National Institutes of Allergy and Infectious Diseases (NIAID).

The candidate vaccine regimen being studied consists of two experimental vaccines including a bivalent gp120 antigen (supplied by GSK) with an adjuvant designed to boost the body’s immune response to the vaccine regemin. Both candidates have been modified to be specific to HIV subtype C, the predominant HIV subtype in southern Africa.

GSK has a long commitment to HIV. Through ViiV Healthcare, we continue to research new treatments and increase access to our medicines for people living with HIV around the world. However with an estimated two million new HIV infections occurring worldwide annually, controlling and ultimately ensuring a durable end to the HIV/AIDS pandemic a safe and effective vaccine will play a critical role in bringing about a durable end to the HIV/AIDS epidemic.