SEATTLE, JUNE 21,2019 – The HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center, has fully enrolled its four ongoing large-scale HIV vaccine efficacy trials. The clinical trials, underway on four continents in 12 countries, are made possible by 12,669 study participants and the collaborative efforts of HVTN study teams, all on a journey to find a safe and effective HIV vaccine. Complete enrollment facilitates the collection and analysis of trial-specific data, enabling researchers to answer research questions.
Nearly 37 million people around the globe live with HIV, with 70 percent of those affected in sub-Saharan Africa. Globally there are an estimated 5,000 new transmissions each day. New, effective prevention strategies are essential to reducing HIV transmission.
“Every day, we recognize and appreciate the unwavering commitment of our study participants, communities, scientific teams, funders, and governments who make the research to help end HIV possible,” said Steven Wakefield, Director of External Relations at the HVTN. “These clinical trials underscore the importance of our global public-private partnerships.”
Public-private partnerships, such as the Pox Protein Public-Private Partnership (P5), are essential to the pursuit of a safe and effective HIV vaccine. Such partnerships draw on collective fiscal resources and scientific leadership and work with in-country communities across continents to make the global response to help end HIV possible.
Summary profiles of large-scale efficacy trials
|HVTN 703 & 704, also known as the Antibody Mediated Prevention (AMP) studies – Fully enrolled, with 4,625 participants from communities in the United States, Brazil, Peru, Switzerland, Tanzania, Zimbabwe, Botswana, South Africa, Kenya, Malawi and Mozambique. The AMP studies are the most advanced clinical trials to test whether a broadly neutralizing antibody (bNAb), called VRC01, can prevent HIV acquisition in people.|
|HVTN 702, also known as Uhambo – Fully enrolled, with 5,407 healthy, HIV-negative men and women between 18 and 35 years old. HVTN 702, underway in South Africa, is testing an experimental vaccine regimen against HIV.|
|HVTN 705, also known as Imbokodo – Fully enrolled, with 2,637 healthy, HIV-negative women in South Africa, Malawi, Mozambique, Zambia, and Zimbabwe between the ages of 18 and 35 years. Imbokodo is testing an experimental vaccine regimen designed to offer protection against a variety of global HIV strains.|
“Our scientific journey is remarkable,” said Larry Corey, M.D., Principal Investigator of the HVTN, virologist and faculty member at Fred Hutchinson Cancer Research Center in Seattle. “We are in a fortunate position to serve global communities through science and work with them to help end HIV.”
Since its inception in 1999, the HVTN has conducted 75 clinical trials involving more than 22,000 study participants in 13 countries. The network currently runs 49 clinical trial sites in nine countries with 18 ongoing trials, four of which are efficacy trials. The network currently engages with approximately 14,000 study participants.
Clinical trial profiles
Antibody Mediated Prevention (AMP)
The AMP clinical trials were opened in May 2016 and are expected to close in late 2021. These clinical trials are designed to determine if a broadly neutralizing antibody (bNAb) called VRC01, given intravenously, can prevent HIV acquisition. In addition, the trials will help to establish the concentrations of bNAbs required for protection, and to characterize any virus that establishes a “breakthrough” HIV infection to understand if it was sensitive or resistant to VRC01. The studies also could clarify what level of neutralization a vaccine or antibody-based method of HIV prevention needs to achieve and maintain to provide sustained protection. The trials are underway in the United States, Brazil, Peru, Switzerland, South Africa, Mozambique, Botswana, Kenya, Malawi, Tanzania and Zimbabwe.
While an experimental HIV vaccine aims to prevent infection by stimulating the immune system of an HIV-negative person to produce protective antibodies, a technique called passive antibody transfer involves giving antibodies directly to an HIV-negative person by injections or intravenous infusions. The AMP Studies are the most advanced human trials to test whether this strategy can prevent HIV acquistion in humans. Study participants are receiving intravenous infusions of the VRC01 bNAb every 8 weeks.
HVTN 702 also called “Uhambo”
HVTN 702 was opened in October 2016 and is expected to close in late 2022. This clinical trial involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 is 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. 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.
NIAID 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).
HVTN 705/HPX2008 also called “Imbokodo”
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. 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 transmissions worldwide in 2017, 16 percent 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. The clinical trial opened in November 2017 and is expected to close in late 2022.
HVTN 705/HPX2008 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.