31 January 2012 - Rockville, USA - The National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), has joined the Phase II clinical trial of a tuberculosis (TB) vaccine candidate jointly developed by Aeras and Dutch biopharmaceutical company Crucell.
NIH has supported TB vaccine development in the past. However this is the first time that NIH will use its HIV/AIDS clinical trial network for tuberculosis vaccine 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 infants who are HIV-negative. Significant support for the trial is also provided by the European and Developing Countries Clinical Trials Partnership and European Member States.
The first NIAID-supported site to join the clinical trial is the Perinatal HIV Research Unit 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, the HIV Prevention Trials Network and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network.
"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 chief executive officer 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.
For more information visit the Aeras website.