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news.The National Institute of Allergy and Infectious Diseases (NIAID) has joined as a partner for a Phase II proof-of-concept trial of a tuberculosis vaccine jointly developed by Aeras and Crucell.
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The trial will evaluate the safety and efficacy of vaccine candidate AERAS-402/Crucell Ad35 in HIV-uninfected infants.
The collaboration follows the NIAID plan to utilize infrastructure originally intended for HIV-related clinical trials to also advance tuberculosis vaccine and therapeutic research for both HIV uninfected and infected populations.
The first NIAID-supported site to join the trial is the Perinatal HIV Research Unit (PHRU) located in Soweto, South Africa at the Chris Hani Baragwanath Hospital, the company said.
Significant support for the trial is also provided by the European and Developing Countries Clinical Trials Partnership (EDCTP) and European Member States.
Aeras president and CEO Jim Connolly said the collaboration with NIAID comes as multiple TB vaccine candidates are poised to enter efficacy trials requiring thousands of participants and significant investment.