HIV Vaccine Trials Network among five nationwide selected to receive seven-year award - Fred Hutchinson Cancer Research Center

NIH funding will propel large-scale HIV vaccine clinical trials in South Africa and beyond

SEATTLE – Dec. 17, 2013 – The HIV Vaccine Trials Network, based at Fred Hutchinson Cancer Research Center, is among five clinical trial networks across the United States that will receive substantial federal funding to continue their work in the fight against HIV/AIDS.

The National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health, announced yesterday that it will fund the five networks for a seven-year cycle starting in 2014. Total funding is expected to reach $225 million next year.

“This funding will help move us toward an effective HIV vaccine that will save lives and reduce the burden of this disease worldwide,” said Fred Hutch President and Director Larry Corey, M.D., one of the HVTN’s three principal investigators.

The HVTN is the world’s largest consortium of clinical and laboratory researchers and educators focused on developing a preventive vaccine against HIV. The need for its work is starkly outlined by statistics: an estimated 36 million people around the world have died of AIDS-related illnesses since the start of the pandemic, according to UNAIDS, the Joint United Nations Programme on HIV/AIDS.

“This is a critical time for the HVTN to apply rigorous laboratory studies to improve our understanding of what a vaccine must do to induce protective immunity and of how best to achieve these responses,” said Julie McElrath, M.D., principal investigator and director of the HVTN Laboratory Center and Seattle Vaccine Trials Unit.

As of 2012, there were 35.3 million people worldwide living with HIV. The highest rates of HIV/AIDS are in South Africa, where there are more than 1,000 new infections daily. In October, the HVTN opened a new state-of-the-art lab in Cape Town, South Africa’s legislative capital, and is preparing to launch a series of clinical trials in the region starting in 2015.

The NIAID grant includes funding for new trial sites in South Africa and neighboring countries to support large-scale efficacy trials needed to develop a licensed HIV vaccine. The South African government, through its Medical Research Council, is a critical partner in the HVTN’s quest to find an affordable and effective HIV vaccine, said Glenda Gray, M.D., a principal investigator for the network who is based in South Africa.

“The expansion of critical capacity by NIAID into southern Africa demonstrates the vision NIAID and the HVTN have in partnering with local scientists to find a biomedical solution to curb HIV in our region,” said Gray, who is also director of the Office of AIDS Research for the South African Medical Research Council.

Corey launched the HVTN in 1999 with an initial NIAID grant of about $700,000. With Corey as its first principal investigator, the network has so far conducted 59 HIV vaccine trials involving more than 15,000 participants and operates clinical trial sites on four continents: North America, South America, Europe, and Africa.

The new NIAID funding is key to the HVTN continuing its work, Executive Director Jim Kublin, M.D., M.P.H., said.

“This funding will help move us toward an effective HIV vaccine that will save lives and help communities devastated by the disease to become healthy and whole,” he said.

The NIAID grants will support three units within the HVTN, all based at Fred Hutch.

The HVTN’s Laboratory Center, run by McElrath, conducts state-of-the-art research around developing an HIV vaccine and is widely considered the worldwide leader in developing assays used to qualify potential vaccines for clinical trials.

The Statistical and Data Management Center, run by Peter Gilbert, Ph.D., integrates data and statistics, and provides the statistical and computational methods and tools needed to design clinical trials and analyze resulting data. Its research centers on ensuring clinical trials yield clear answers about whether candidate vaccines are working and learning the characteristics of vaccination associated with protection.

The Leadership and Operations Center provides scientific direction and leadership for the HVTN, prioritizing research concepts, coordinating and developing trial protocols and sharing research results. It also handles administrative leadership of the network, including governance principles, site coordination and resource management. The center is overseen by Corey, Gray and Scott Hammer, M.D., chief of the Division of Infectious Diseases at Columbia University in New York.

The other networks receiving the new NIAID funding include:

  • AIDS Clinical Trial Group in Boston, Mass.
  • HIV Prevention Trials Network in Durham, N.C.
  • International Maternal Pediatric Adolescent AIDS Clinical Trials in Baltimore, Md.
  • Microbicide Trials Network in Pittsburgh, Pa.

In 2010, the NIAID decided that the HIV/AIDS networks it was funding should expand their focus to create an infrastructure that could support other infectious diseases. The new funding is intended to bolster the networks’ activities in the U.S. and abroad to include the treatment and prevention of other diseases, particularly tuberculosis and hepatitis, which frequently affect the same populations impacted by HIV.

Additionally, the NIAID aims to increase collaboration across the networks, create transparent mechanisms for network leaders to solicit and support ideas from the research community, and develop a way for external researchers to tap into the networks’ infrastructure and capacity.

The new funding positions the HVTN to move forward in its next phase of clinical trials, Hammer said.

“The HVTN, in collaboration with its many partners, looks forward to this next funding cycle as we are better prepared than ever before to meet the scientific challenge of developing a safe and effective HIV vaccine,” he said.

The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network’s HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The Network’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.