NIH-funded HIV clinical research sites to join pediatric tuberculosis vaccine study
January 31, 2012 - Several U.S. government-funded HIV/AIDS clinical research sites in Africa will
join other collaborators in an ongoing clinical trial testing an investigational tuberculosis (TB) vaccine in infants at risk for
TB infection. "We are pleased to be able to tap into our existing HIV/AIDS clinical research infrastructure to help test
promising investigational vaccines against TB," said NIAID Director Anthony S. Fauci, M.D. The sites are funded by the
National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The Phase II proof-of-concept study is testing the safety and effectiveness of an investigational booster
TB vaccine developed by Aeras, a Rockville, Md.-based nonprofit organization focused on developing vaccines and other
products to prevent TB, and Crucell N.V., a biopharmaceutical company based in the Netherlands.
The trial began in October 2010 and is now ongoing at three sites in Kenya, South Africa and Mozambique.
It is sponsored by Aeras and receives funding from Aeras, Crucell and the European and Developing Countries Clinical
The trial, which will enroll HIV-uninfected infants ages 16 weeks to 26 weeks, is testing the
AERAS-402/Crucell Ad35 candidate TB vaccine as a booster immunization to the current bacille Calmette-Guérin
(BCG) TB vaccine. In countries where TB is highly endemic, the World Health Organization (WHO) recommends
that all infants receive the BCG vaccine at birth. It is not routinely administered to infants in the
United States. The BCG vaccine, first administered to humans in 1921, is the only licensed TB
vaccine and reduces the risk of some forms of TB in children. However, it provides limited
protection against adult pulmonary TB, the contagious and most common form of TB.
To allow for increased enrollment, the study is now being expanded to include up to six NIAID-supported clinical trial sites
in sub-Saharan Africa. The first of these sites to join the trial is the Perinatal HIV Research Unit at the Chris Hani Baragwanath Hospital
in Soweto, South Africa. The site is a member of several NIAID-funded clinical trials 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). The HPTN is largely funded by NIAID with additional funding by the National Institute on Drug
Abuse and the National Institute of Mental Health, all part of the NIH. IMPAACT is funded by NIAID and
the Eunice Kennedy Shriver National Institute of Child Health and Human Development, also part of the NIH.
Additional IMPAACT sites are expected to participate in the clinical trial when the next stage of enrollment opens in
The AERAS 402/Crucell Ad35 vaccine is being given as a booster immunization to healthy infants who received the BCG
vaccine at birth to determine if the investigational vaccine can increase protection against TB. The recombinant vaccine uses a
live, non-replicating adenovirus (Ad35) to deliver three specific Mycobacterium tuberculosis antigens designed to stimulate
the immune system and protect against TB. The vaccine does not contain live TB and cannot cause vaccinated infants to
become infected with TB. The investigational vaccine had an acceptable safety profile in previous clinical trials
among healthy adults and infants, as well as among HIV-infected adults and adults with latent TB.
The study was approved by ethics committees at each participating site as well as by national
regulatory authorities in each of the participating countries. Additionally, an independent
data and safety monitoring board regularly reviews the study data to ensure the protection
of the study participants. Informed consent by a parent or legally authorized
representative is required to enroll an infant into the study. The study
is expected to be completed in 2015.
According to the WHO, in 2010 TB sickened 8.8 million people and killed 1.4 million people worldwide.
It is a leading cause of death among people who are also infected with HIV. In Africa, there were an
estimated 2.3 million TB cases and 254,000 TB deaths in 2010.
For more information about clinical trial NCT01198366 visit clinicaltrials.gov. For more information about tuberculosis, see the NIAID Tuberculosis Web portal .
NIAID conducts and supports research - at NIH, 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.
News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site
at http://www.niaid.nih.gov .
About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health
and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical
research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information
about NIH and its programs, visit www.nih.gov .