Dengue vaccine trials start in Singapore
Richard Philip
Medical Tribune
 
Singapore will take part in a global clinical trial program to develop a vaccine for dengue.
 
The phase II trial, conducted by French drugmaker Sanofi Pasteur in collaboration with several hospitals here, will test the safety and immunogenicity of a candidate dengue vaccine.
 
“Controlling the mosquitoes that transmit dengue is necessary but not sufficient to fight against the disease. A safe and effective vaccine has been long awaited to prevent dengue epidemics,” said Professor Leo Yee Sin, director of the Communicable Disease Centre in Singapore.
 
“Clinical studies in Singapore are critical steps to advance the development of a vaccine for the prevention of dengue in Asia. We are happy to contribute to scientific research that would benefit the entire region,” said Leo, who will act as medical advisor to Sanofi Pasteur and oversee the entire study in Singapore.
 
There are four known strains of dengue virus and they circulate in most dengue endemic areas, such as Singapore and the rest of Southeast Asia. According to Leo, a person who has been infected with one strain will develop immunity against that strain but will still be susceptible to other strains.
 
“We need to be sure that we give a combined dengue vaccine that will develop an immune response to all four serotypes at the same time,” said Dr. Melanie Saville, head of Sanofi Pasteur’s clinical dengue program.
 
Approximately 1,200 subjects will be recruited for this double-blind, randomized controlled study, which will take place at four public hospitals in Singapore – the National University Hospital, Singapore General Hospital, Changi General Hospital and KK Women’s and Children’s Hospital.
 
Participants will be divided into three age groups – children (2-11 years), teenagers (12-17 years) and adults (18-45 years). Each group will consist of 400 participants, of whom 300 will receive the dengue vaccine and 100 will receive a control vaccine. The injections will be given at 0, 6 and 12 months, after which subjects will be followed up for 4 years.
 
We want to look at the safety of the dengue vaccine compared to the control vaccine and measure whether or not they produce acceptable levels of antibodies against infections, said Leo.
 
Sanofi Pasteur will also be doing a similar study in Vietnam concurrently so that researchers can capture data on all the relevant populations in dengue endemic areas. The studies in Singapore and Vietnam will add to the data from the drug company’s other ongoing dengue vaccine trials in Thailand and the Philippines.


  
 
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