IAVI – International AIDS Vaccine Initiative [to 4 February 2017]
February 2, 2017
IAVI Sponsors Phase I Clinical Trial of a Broadly Neutralizing HIV Antibody
The International AIDS Vaccine Initiative (IAVI) is sponsoring a Phase 1 clinical trial (T001) led by the Beth Israel Deaconess Medical Center (BIDMC) to investigate the safety and tolerability of a broadly neutralizing antibody infusion (bNAb) to prevent HIV infection.
A maximum of 93 volunteers will receive one-time infusions of the bNAb PGT121 at varying dosages with six months of follow-up as part of T001, which will include HIV-uninfected adults, HIV-infected adults on anti-retroviral therapy (ART) with suppressed viral loads and HIV-infected adults not on ART. Results are expected in 2018.
Preclinical data suggests that bNAbs, which have neutralized a broad spectrum of HIV-1 variants in laboratory tests, can protect people from HIV infection. bNAbs can either be administered passively through infusion or generated actively by the immune system through vaccination.
PGT121 was isolated by scientists from IAVI’s Neutralizing Antibody Consortium at The Scripps Research Institute. This antibody comes out of the landmark Protocol G, a global search for bNAbs in blood samples from people living with HIV, supported by the United States Agency for International Development (USAID).
PGT121 is being developed and tested for HIV prevention by BIDMC, supported by the Bill & Melinda Gates Foundation through a Collaboration for AIDS Vaccine Development (CAVD) grant to the BIDMC. IAVI is sponsoring the study through its Vaccine Product Development Center (VxPDC), which provides CAVD grantees with the required expertise and support to advance promising approaches to HIV prevention more rapidly from early stages of development to clinical trials.