NIH to Join Multi-center Clinical Trial of New Tuberculosis Vaccine
Aeras leverages US government clinical trial networks designed for HIV research to support TB vaccine development
ROCKVILLE, MD, USA, January 31, 2012 - 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.
About the Clinical Trial Field Sites
The clinical trial is also ongoing in Kenya led by KEMRI/CDC; in South Africa led by the South African Tuberculosis Vaccine Initiative (SATVI); and in Mozambique led by the Manhica Health Research Centre (CISM). To learn more click on their names to view their websites.
Follow this link to read more about Phase IIb clinical trials.
About AERAS-402/Crucell Ad35
In 2004, Aeras and Crucell began joint development of this vaccine candidate. AERAS-402/Crucell Ad35 has been tested in 13 completed or ongoing early-stage clinical trials. These trials include healthy adults and infants as well as adults with HIV infection and adults with recently treated pulmonary tuberculosis. The vaccine candidate has been shown to be immunogenic and to have an acceptable safety profile in these studies.
Tuberculosis is the world's second deadliest infectious disease, with 8.8 million new cases diagnosed in 2010. According to the World Health Organization (WHO), an estimated 1.4 million people died from TB in 2010. An estimated one-third of the world's population has been infected with the TB bacillus. Current guidelines require a minimum of six to nine months of treatment. The current TB vaccine, Bacille Calmette-Guérin (BCG), developed 90 years ago and given to newborn infants, reduces the risk of severe forms of TB in early childhood but is not very effective in preventing pulmonary TB in adolescents and adults - the populations with the highest rates of TB disease. TB is changing and evolving, making new vaccines more crucial for controlling the pandemic. Tuberculosis is now the leading cause of death for people living with HIV/AIDS, particularly in Africa. Multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) are hampering treatment and control efforts.
Aeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras has invented or supported the development of six TB vaccine candidates, which are undergoing Phase I and Phase II clinical testing in Africa, Asia, North America and Europe. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations, and governments. Aeras is based in Rockville, Maryland, USA where it operates a state-of-the-art manufacturing and laboratory facility, and Cape Town, South Africa.
About the National Institute of Allergy and Infectious Diseases
NIAID conducts and supports research-at the US National Institutes of Health, throughout the United States, and worldwide-to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. For more information about NIAID visit www.niaid.nih.gov/.