The trial was the first to test this vaccine candidate, which is designed to block the malaria parasite from entering human blood cells, in a malaria-endemic country. Based on these promising results, the research team is now conducting trials of this vaccine in 400 Malian children aged 1 to 6 years.
Malaria is a leading killer in Africa and other developing countries, claiming more than 1 million lives each year, most of them children.
Lead investigator Mahamadou A. Thera M.D., MPH, and 16 other co-authors of the newly published study are based at the Malaria Research and Training Center at the University of Bamako, Mali. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, supported the trial and helps fund the Center. University of Maryland School of Medicine researcher Christopher Plowe, M.D., MPH, was the co-leader of the study.
The trial enrolled volunteers living in Bandiagara, a rural town in northeast Mali with a heavy burden of malaria. In this relatively dry region, almost no new infections occur during the driest month of the year, March, but people typically get up to 60 malaria-transmitting mosquito bites per month in August and September, when the rainy season peaks.
A total of 60 participants were assigned at random to receive either a full or half-dose of the candidate malaria vaccine or a licensed rabies vaccine, which served as a control. Each volunteer received three injections, spaced one month apart. Injections began in late December 2004, at the end of the malaria transmission season. As expected, all volunteers had significant levels of antibodies against malaria parasites detectable in their blood at the beginning of the trial, signaling that they had prior exposure to malaria parasites.
Those who received the candidate vaccine tolerated it very well and experienced a significant boost (up to a sixfold rise) in levels of vaccine-specific antibodies, while those who received the rabies vaccine had declining levels of antibodies as the rainy season receded.
Other collaborators included scientists from Walter Reed Army Institute of Research, Silver Spring, Maryland; the U.S. Agency for International Development, Washington, DC; and GlaxoSmithKline Biologicals, in Rixensart, Belgium.
ARTICLE: MA Thera et al. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: Results of a Phase 1 randomized controlled trial. PLoS ONE DOI: 10.1371/journal.pone.0001456 (2008). The paper will be available from the journal after 8 pm. ET Jan. 22, 2008 at: http://www.plosone.org/doi/pone.0001465
WHO: Anthony S. Fauci, M.D., Director, NIAID, and Lee Hall, M.D., Ph.D., Chief, NIAID Parasitology and International Programs Branch, are available to discuss this research and NIAID’s research projects in malaria vaccine development.
CONTACT: To schedule interviews, contact Anne A. Oplinger in the NIAID Office of Communications and Government Relations at 301-402-1663 or firstname.lastname@example.org.
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (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. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases.
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