PATH Malaria Vaccine Initiative (MVI) Creates New Central "Reference" Lab, Standardizing Ability to Measure Performance of Malaria Vaccine Formulations

MVI, International AIDS Vaccine Initiative, and Imperial College London

Establish Collaboration to Guide Selection and Prioritization of Malaria Vaccine Candidates

WASHINGTON, Aug. 20, 2012 /PRNewswire-USNewswire/ -- In response to a critical gap in developing malaria vaccines, the PATH Malaria Vaccine Initiative (MVI) announced a new collaboration today with the International AIDS Vaccine Initiative (IAVI) and Imperial College London to measure the capacity of different vaccine candidates in human clinical testing to elicit an immune response aimed at protecting against deadly malaria parasites.

"Until now, malaria vaccine scientists have struggled to directly compare the cellular immune response elicited in humans by one vaccine to that of another, and this has hampered the ability to prioritize a portfolio of vaccine candidates," said David C. Kaslow, M.D., director of MVI. "We are fortunate to have in IAVI and Imperial College London partners with a track record of developing validated human immunological assays. Through this new collaboration, we look forward to being able to make better informed decisions about if and how various malaria vaccines elicit immune responses at the cellular level in humans."

One obstacle to comparing the cell-mediated immunity elicited by different malaria vaccine candidates has been the lack of uniform validated techniques and processes among the various laboratories used by MVI and its collaborators specifically to evaluate T-cell immunity. Previously, AIDS vaccine researchers faced similar challenges. In an effort to identify a more consistent understanding of how multiple vaccine candidates were performing at a cellular level, IAVI and its Human Immunology Laboratory (HIL) at Imperial College London refined and validated specific tests, or assays, that measure vaccine-induced, cell-mediated immunity. The HIL is accredited in Good Clinical Laboratory Practices (GCLP), an internationally recognized quality standard.

In 2006, the wider scientific community cited in its Malaria Vaccine Technology Roadmap the development of a standard set of assays with standardized procedures to enable comparisons of the immune responses of vaccines. This was one of several priority areas critical to accelerating the pace of malaria vaccine development. Kaslow noted that this new collaboration directly addresses the need identified in the Roadmap as well as a critical gap faced in managing a portfolio of malaria vaccine projects—that is, the need for fully comparable data to guide transparent, objective, data-driven portfolio decisions.

"We are pleased that IAVI can contribute to informed, data-driven decisions on vaccine approaches," said Margaret McGlynn, President and Chief Executive Officer of IAVI. "Many of the methods and strategies employed in AIDS vaccine development could be of use in efforts to develop a malaria vaccine. Our collaboration will allow investments in AIDS vaccine R&D to benefit efforts to prevent another disease of great relevance to global health."

Under the agreement, IAVI and its laboratory partner at Imperial College London will focus on providing two types of assays for MVI and its collaborators as they move vaccine candidates into clinical trials: the Interferon-gamma ELISpot assay and a multi-color flow cytometry assay. These tests will be used to detect the disease-fighting cells, or T cells, that may be present in the blood of volunteers after vaccination.

"These tests can provide quantitative information, such as how many cells responded to the vaccine, along with qualitative information, such as the different cell types that were stimulated," said Professor Gavin Screaton, Head of the Department of Medicine at Imperial College London. "Both types of information can be important in determining the power of the overall vaccine-induced immune response."

"We're delighted to be hosting this work at Imperial, which builds on our longstanding fruitful association with IAVI," he said. "We're also looking forward to working more closely with MVI as part of our commitment to vaccine research and international health."

MVI's Kaslow said the tests will help MVI prioritize investments and allow scientists to refine vaccine strategies by showing whether a particular formulation, delivery approach, or vaccine adjuvant elicits a superior cell-mediated immune response. However, he emphasized that results from the assays are just one piece of evidence that MVI will use to guide Go/No-go decisions in malaria vaccine development. He noted that while the collaboration with IAVI and Imperial College London will provide MVI with a central "reference" laboratory for measuring cell-mediated immune responses, MVI encourages malaria vaccine developers to continue performing their own tests as well.

"At MVI, we need standardization of these assays because when we analyze the results from various trials and look at the data on cell-mediated immunity, we need to be sure that any differences are not caused by variations in how the tests were done," Kaslow said.

Editor's Note: For more details, go to: Developing malaria vaccines: Investing in the tools of the trade.

About the PATH Malaria Vaccine Initiative:

www.malariavaccine.org

About PATH: PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential. For more information, please visit www.path.org.

About IAVI: The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates. In addition, IAVI conducts policy analyses and serves as an advocate for the AIDS vaccine field. IAVI supports a comprehensive approach to addressing HIV and AIDS that balances the expansion and strengthening of existing HIV-prevention and treatment programs with targeted investments in the design and development of new tools to prevent HIV. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it. IAVI relies on the generous donations from governments, private individuals, corporations and foundations to carry out its mission. For more information, please visit www.iavi.org.

About Imperial College London: Consistently rated amongst the world's best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 14,000 students and 6,000 staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment - underpinned by a dynamic enterprise culture.

Since its foundation in 1907, Imperial's contributions to society have included the discovery of penicillin, the development of holography and the foundations of fibre optics. This commitment to the application of research for the benefit of all continues today, with current focuses including interdisciplinary collaborations to improve global health, tackle climate change, develop sustainable sources of energy and address security challenges.

In 2007, Imperial College London and Imperial College Healthcare NHS Trust formed the UK's first Academic Health Science Centre. This unique partnership aims to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible. For more information, please visit: www.imperial.ac.uk.

For more information, please contact:
Katy Lenard, for the PATH Malaria Vaccine Initiative,
+1 301-280-5719 or [email protected]
Lauren Wesolowski, for IAVI
+1 212-328-7420

SOURCE PATH Malaria Vaccine Initiative