Infants enrolled in Africa for Phase II trials of a TB vaccine.

By Ochieng’ Ogodo

A Phase II clinical trials aimed at developing TB vaccine and 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.

This trial has received significant support from, among others, the European and Developing Countries Clinical Trials Partnership (EDCTP) and European Member States.

And 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 the Phase II proof-of-concept clinical trial of a tuberculosis vaccine candidate jointly developed by Aeras and Dutch biopharmaceutical company Crucell.

 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 that includes 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 in après release.

 "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. 

NIH has a long history of supporting TB vaccine development. But this is the first time for it to leverage 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.