Aeras joins with NIAID for TB clinical test
Aeras, the Dutch biopharmaceutical Crucell and the NIAID, which is part of the U.S. National Institutes of Health, will partner for the Phase II proof-of-concept clinical trial. The collaboration fits NIAID plans to leverage a portion of its infrastructure originally intended to carry out HIV-related clinical trials.
One-third of the world's population is thought to be infected with TB, and those with HIV are at increased risk because the virus weakens the body's immune system. NIAID views the partnership as a means of advancing TB research while continuing to advance therapeutic HIV research for uninfected and infected 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," Mary Woolley, the CEO and president of Research!America, a nonprofit health education and advocacy group, said.
The purpose of the trial, which was initiated in October 2010, is to evaluate the safety and efficacy of the TB vaccine candidate known as AERAS-402/Crucell Ad35 in HIV-uninfected infants. It is scheduled to take place at three sites in Kenya, South Africa and Mozambique.
In addition, the partnership has received support from the European and Developing Countries Clinical Trials Partnership and by members of the European Union.
"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," Aeras CEO and President Jim Connolly said. "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 site."