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.
About IAVI’s NAC and Protocol G
IAVI launched the Neutralizing Antibody Consortium (NAC) in 2002 to study the structure and interaction of known broadly neutralizing antibodies, to identify and characterize new, more effective broadly neutralizing antibodies and to use this information to design (reverse engineer) potentially powerful AIDS vaccine candidates. In 2006, IAVI and partners, including The Scripps Research Institute, clinical research centers in seven sub-Saharan African countries as well as in Thailand, Australia, the UK and the US, and the biotech companies Theraclone and Monogram Biosciences, launched an ambitious project to identify such antibodies. Protocol G enlisted 1,800 people living with HIV who volunteered to provide blood samples. In 2009, the scientists isolated and characterized the first new broadly neutralizing antibody to HIV seen in a decade and the first to be isolated from donors in developing countries, where the majority of new HIV infections occur. To date, dozens of new bNAbs have been isolated and characterized from Protocol G specimens, and many have been shared with researchers across the AIDS vaccine field, driving new strategies to induce their production through vaccination.
Protocol G was made possible by the generous support of the American people through USAID. The contents are the responsibility of the International AIDS Vaccine Initiative and do not necessarily reflect the views of USAID or the United States Government. USAID administers the US foreign assistance program providing economic and humanitarian assistance in more than 120 countries worldwide. The full list of IAVI donors is available here.