The Ministry of Health has approved human tests of Vietnamese-made H5N1 vaccine, said Mr. Nguyen Thu Van, director of Vaccine and Bio-Technology Products Company Number 1.
Tests will begin at the Military Medicine Institute next month and its students will take part in the experiment. The eight-month-long test period will involve around 300 healthy volunteers aged 18 to 45.
The volunteers must not suffer chronic diseases like hepatitis B, C, HIV, or tuberculosis and they must not be pregnant women.
In the first phase of the tests, 30 volunteers will be used to evaluate the vaccine’s effectiveness, safety, and try to determine proper dosage. A second phase will require more subjects.
The vaccine is made from the monkey kidney cells and uses the latest bio-technology available in Viet Nam.
Nha Trang National Institute of Biological Products and Vaccine Production announced that five batches of the vaccine were produced from chicken embryos. This vaccine was checked for quality by injecting it into house mice, guinea-pigs and chickens.
If the human testing has a positive result, the vaccine could become available to the public by the end of 2009.