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 Trials Partnership.
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 several months.
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.
