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NIH to join multi-center clinical trial of new tuberculosis vaccine

Rockville, MD, USA Aeras announces today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), has joined as a partner for a Phase II proof-of-concept clinical trial of a tuberculosis vaccine candidate jointly developed by Aeras and Dutch biopharmaceutical company Crucell.

NIH has a long history of supporting TB vaccine development. However, this is the first time that NIH is leveraging its HIV/AIDS clinical trial networks to advance a tuberculosis vaccine candidate. Along with the recent announcement of NIAID's new partnership in a Phase III TB drug trial, this collaboration follows the NIAID plan to leverage infrastructure originally intended for HIV-related clinical trials to also advance tuberculosis vaccine and therapeutic research for both HIV uninfected and infected populations.

One-third of the world's population is infected with tuberculosis. Infants and people who are immune compromised, including those with HIV infection, are at higher risk of developing active TB. Safe and effective vaccines hold promise for protecting these at-risk populations.

"NIAID's involvement in this important clinical trial will maximize return on U.S. government investment in clinical research infrastructure while accelerating progress against the world's deadliest infectious disease after HIV/AIDS," said Mary Woolley, CEO and President of Research!America, the nation's largest not-for-profit public education and advocacy alliance committed to research.

The clinical trial, which began in October 2010, has already enrolled infants at three sites in Kenya, South Africa and Mozambique. The goal of the trial is to evaluate the safety and efficacy of vaccine candidate AERAS-402/Crucell Ad35 in HIV-uninfected infants. Significant support for the trial is also provided by the European and Developing Countries Clinical Trials Partnership (EDCTP) and European Member States.

The first NIAID-supported site to join the clinical trial is the Perinatal HIV Research Unit (PHRU) located in Soweto, South Africa at the Chris Hani Baragwanath Hospital. The research site is a member of NIAID-funded clinical trial networks including the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).

"Our novel collaboration with NIAID comes as multiple TB vaccine candidates are poised to enter efficacy trials requiring thousands of participants and significant investment, as well as complex infrastructure and sophisticated expertise," said Jim Connolly, President and CEO of Aeras.

"We are grateful for the partnership of one of the most well-respected biomedical research institutes in the world, and the opportunity to utilize well-established clinical sites," he added.

Contact: Annmarie Leadman

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