Pediatric Clinical Trial for GlaxoSmithKline Malaria Vaccine To Begin Next Month in The Gambia

Apr 25, 2001, 01:00 ET from GlaxoSmithKline plc

    PHILADELPHIA, April 25 /PRNewswire/ -- Screening of children has begun for
 the clinical trial of a promising malaria vaccine set to start early next
 month in The Gambia, West Africa.  The trial is the first of a series of three
 planned in The Gambia through a partnership between the Malaria Vaccine
 Initiative at PATH (Program for Appropriate Technology in Health, a US-based
 nonprofit organization), and GlaxoSmithKline Biologicals (GSK), the world's
 largest vaccine manufacturer.  The Gambian clinical trial is the first
 concrete step in a new partnership between MVI and GSK.  The Gambian unit of
 the UK's Medical Research Council (MRC) will conduct the trial in Basse Santa
 Su, a region in the country's northwest where malaria is endemic.
     Today's announcement comes on Africa Malaria Day, as declared last year by
 African Heads of State in the Abuja Declaration and Plan of Action.  Malaria
 currently infects an estimated 300 to 500 million people.  Another 2.3 billion
 are at risk of the disease, making development of a malaria vaccine a global
 health priority.  Those most vulnerable to malaria are children under five
 years of age and pregnant women.
     "These trials are an important step forward in creating a malaria vaccine
 for children in Africa," said Regina Rabinovich, MD, Director of the Malaria
 Vaccine Initiative at PATH.  "Most of the more than one million people who die
 of malaria every year are African children under the age of five."  No malaria
 vaccines have ever been tested and found successful in children.
     "As we mark Africa Malaria Day, we are pleased to announce this major
 advance toward the goal of preventing malaria," said Jean Stephenne, President
 and General Manager, GlaxoSmithKline Biologicals.  "We are committed to
 delivering a vaccine that will protect African children from this devastating
 disease.  These trials are a critical step in that process."
     The first trial, which will involve approximately 90 children between six
 and eleven years of age, will test the safety and immune response of
 GlaxoSmithKline's "RTS,S" vaccine.  Pending positive results, two subsequent
 trials will test the vaccine in children between one and five years old.
 Researchers have already safely tested the vaccine in adult volunteers in the
 United States, Belgium, Kenya, and The Gambia.  It demonstrated a 70 per cent
 efficacy rate in protecting adults in The Gambia against infection over a
 short period of time, making it the world's only malaria vaccine candidate to
 have shown that level of efficacy.
     During the upcoming children's trials, MRC investigators will encourage
 families to take the normally recommended malaria prevention measures.  They
 will closely monitor the children for at least two malaria seasons, which
 coincide with the annual rainy season, and treat any child who contracts
 malaria.  "Investigators at MRC/Gambia will carefully evaluate each child
 throughout the trial," said Keith McAdam, Director of MRC/Gambia.  "We are
 hopeful that the promising results from the adult trial will translate to a
 safe vaccine that will protect children for a longer period of time."
     Malaria is a parasitic infection transmitted through the bite of the
 Anopheles mosquito.  Currently, no vaccine is licensed to protect against
 malaria.  Anti-malarial drugs are available, but the parasite has consistently
 developed resistance to them, leaving millions vulnerable to the disease.
     GlaxoSmithKline Biologicals, the world's leading vaccine manufacturer,
 last year distributed over 1.1 billion doses of vaccines to 177 countries, an
 average of 35 per second.  For information, visit GlaxoSmithKline's vaccine
 web site at www.worldwidevaccines.com.
     GlaxoSmithKline (NYSE:   GSK) - one of the world's leading research-based
 pharmaceutical and healthcare companies - is committed to improving the
 quality of human life by enabling people to do more, feel better, and live
 longer.
     The Malaria Vaccine Initiative (MVI) at PATH seeks to accelerate the
 development of promising malaria vaccines and ensure their availability for
 the developing world.  For further information about MVI and PATH, visit the
 web sites at www.malariavaccine.org and www.path.org.
     The Medical Research Council has worked in The Gambia for 50 years and has
 developed a strong relationship with the community and the government.  As a
 result, more than 90 per cent of Gambia's children are immunized against the
 major childhood diseases - a slightly higher rate of immunization than in the
 United States.  For further information about MRC, visit the web site at
 www.mrc.ac.uk.
 
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SOURCE GlaxoSmithKline plc
    PHILADELPHIA, April 25 /PRNewswire/ -- Screening of children has begun for
 the clinical trial of a promising malaria vaccine set to start early next
 month in The Gambia, West Africa.  The trial is the first of a series of three
 planned in The Gambia through a partnership between the Malaria Vaccine
 Initiative at PATH (Program for Appropriate Technology in Health, a US-based
 nonprofit organization), and GlaxoSmithKline Biologicals (GSK), the world's
 largest vaccine manufacturer.  The Gambian clinical trial is the first
 concrete step in a new partnership between MVI and GSK.  The Gambian unit of
 the UK's Medical Research Council (MRC) will conduct the trial in Basse Santa
 Su, a region in the country's northwest where malaria is endemic.
     Today's announcement comes on Africa Malaria Day, as declared last year by
 African Heads of State in the Abuja Declaration and Plan of Action.  Malaria
 currently infects an estimated 300 to 500 million people.  Another 2.3 billion
 are at risk of the disease, making development of a malaria vaccine a global
 health priority.  Those most vulnerable to malaria are children under five
 years of age and pregnant women.
     "These trials are an important step forward in creating a malaria vaccine
 for children in Africa," said Regina Rabinovich, MD, Director of the Malaria
 Vaccine Initiative at PATH.  "Most of the more than one million people who die
 of malaria every year are African children under the age of five."  No malaria
 vaccines have ever been tested and found successful in children.
     "As we mark Africa Malaria Day, we are pleased to announce this major
 advance toward the goal of preventing malaria," said Jean Stephenne, President
 and General Manager, GlaxoSmithKline Biologicals.  "We are committed to
 delivering a vaccine that will protect African children from this devastating
 disease.  These trials are a critical step in that process."
     The first trial, which will involve approximately 90 children between six
 and eleven years of age, will test the safety and immune response of
 GlaxoSmithKline's "RTS,S" vaccine.  Pending positive results, two subsequent
 trials will test the vaccine in children between one and five years old.
 Researchers have already safely tested the vaccine in adult volunteers in the
 United States, Belgium, Kenya, and The Gambia.  It demonstrated a 70 per cent
 efficacy rate in protecting adults in The Gambia against infection over a
 short period of time, making it the world's only malaria vaccine candidate to
 have shown that level of efficacy.
     During the upcoming children's trials, MRC investigators will encourage
 families to take the normally recommended malaria prevention measures.  They
 will closely monitor the children for at least two malaria seasons, which
 coincide with the annual rainy season, and treat any child who contracts
 malaria.  "Investigators at MRC/Gambia will carefully evaluate each child
 throughout the trial," said Keith McAdam, Director of MRC/Gambia.  "We are
 hopeful that the promising results from the adult trial will translate to a
 safe vaccine that will protect children for a longer period of time."
     Malaria is a parasitic infection transmitted through the bite of the
 Anopheles mosquito.  Currently, no vaccine is licensed to protect against
 malaria.  Anti-malarial drugs are available, but the parasite has consistently
 developed resistance to them, leaving millions vulnerable to the disease.
     GlaxoSmithKline Biologicals, the world's leading vaccine manufacturer,
 last year distributed over 1.1 billion doses of vaccines to 177 countries, an
 average of 35 per second.  For information, visit GlaxoSmithKline's vaccine
 web site at www.worldwidevaccines.com.
     GlaxoSmithKline (NYSE:   GSK) - one of the world's leading research-based
 pharmaceutical and healthcare companies - is committed to improving the
 quality of human life by enabling people to do more, feel better, and live
 longer.
     The Malaria Vaccine Initiative (MVI) at PATH seeks to accelerate the
 development of promising malaria vaccines and ensure their availability for
 the developing world.  For further information about MVI and PATH, visit the
 web sites at www.malariavaccine.org and www.path.org.
     The Medical Research Council has worked in The Gambia for 50 years and has
 developed a strong relationship with the community and the government.  As a
 result, more than 90 per cent of Gambia's children are immunized against the
 major childhood diseases - a slightly higher rate of immunization than in the
 United States.  For further information about MRC, visit the web site at
 www.mrc.ac.uk.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X70843629
 
 SOURCE  GlaxoSmithKline plc