SEATTLE – DECEMBER 20, 2018
The HIV Vaccine Trials Network (HVTN), which is headquartered at the Fred Hutchinson Cancer Research Center, and its partners are conducting two large-scale clinical trials evaluating the safety and efficacy of experimental HIV vaccine regimens as part of a global response to the HIV and AIDS epidemic. One of these trials, called HVTN 702, was launched in November 2016 in South Africa and has enrolled 4, 611 of 5,400 study participants (85 percent). The second study, called Imbokodo or HVTN 705/HPX2008, recently reached 53 percent enrollment, having enrolled 1, 384 of 2,600 women in southern Africa since its launch in November 2017.
HVTN 702 involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. The study aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial ever to take place in South Africa, where more than 1,000 people acquire HIV every day. The experimental vaccine regimen being tested in HVTN 702 is based on the one investigated in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. The Thai trial delivered landmark results in 2009 when it found for the first time that a vaccine could confer protection, albeit modest, against HIV infection. The new regimen aims to provide greater and more sustained protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa.
“We continue to work in those communities which may benefit most from an HIV vaccine,” said Steven Wakefield, HVTN director of External Relations. “We do this research with and for communities, and not on them by ensuring all involved understand we hope to find ways to protect persons from ever becoming infected”.
The HVTN 705/HPX2008 trial, a proof-of-concept study, is also known as Imbokodo, meaning “rock” in isiZulu. The name comes from a popular African proverb, “Wathint’ abafazi, Wathint’ imbokodo!” — “You strike the women, you strike the rock!” in recognition of the strength women show in the face of challenges. Imbokodo aims to enroll 2,600 HIV-negative women between the ages of 18 to 35 years. The vaccine regimen being tested in Imbokodo is based on “mosaic” immunogens — vaccine components designed to induce immune responses against a wide variety of global HIV strains. Of the 1.8 million new HIV infections worldwide in 2017, 16 percent of new HIV infections occurred in eastern and southern Africa. Support from study participants, communities and in-country partnerships in Malawi, Mozambique, South Africa, Zambia and Zimbabwe is helping move the study forward.
Since its inception in 1999, the HVTN has conducted 79 clinical trials involving more than 22,000 study participants in 13 countries. The network, with the leadership of renowned virologist Dr. Larry Corey, currently runs 49 clinical trial sites in nine countries that conduct 16 ongoing trials, four of which are efficacy trials and 12 of which are early phase trials. The HVTN currently engages with approximately 12,000 study participants.
“Our progress to date is evidence of the critical role that public-private partnerships play in our global response to the HIV and AIDS epidemic,” said Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center in Seattle. “Our study participants are our most critical partnership, as they demonstrate a generous commitment to help end the HIV pandemic.”
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the sponsor of HVTN 702, which is co-funded by NIAID, the Bill & Melinda Gates Foundation and the South African Medical Research Council (SAMRC).
Imbokodo is sponsored by Janssen Vaccines & Prevention, B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, with co-funding from two primary partners, the Bill & Melinda Gates Foundation and NIAID. SAMRC is helping implement the study in South Africa. Additional partners providing support include the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research, the U.S. Army Medical Materiel Development Activity and the Ragon Institute of MGH, MIT and Harvard.
About Fred Hutchinson Cancer Research Center:
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network.