Human testing of Vietnamese-made H5N1 vaccine

Published 23 April 2008

Vietnam begins human testing of Vietnamese-made H5N1 vaccine; initial tests involve 240 volunteers; Vietnam has already tested avian flu vaccine on monkeys and reports results were encouraging

The first phase of the human testing of Vietnamese-made H5N1 influenza vaccine officially began Saturday. Twenty-four students of the Military Medical Institute — seventeen men and seven women — and six officials of the institute have volunteered to participate in the testing. According to Dr. Doan Huy Hong, head of the institute’s Epidemiological Department, the first phase of the experiment will last for fifty-six days and will test the vaccine’s safety level. Directly after receiving the first shot of the vaccine, the volunteers will undergo regular medical check-ups and three blood tests to search for the antigen. On the twenty-eights day after the vaccination, the thirty volunteers will be injected with the second shot of the vaccine and receive regular medical check-ups and three blood tests thereafter. Hong stressed that the second phase of the experiment will be carried out on a larger scale with the number of volunteers reaching 240 people. They will be chosen from 400 people from 18 to 30 years old and will undergo testing over a 90 day period to help scientists evaluate the vaccine’s capacity to produce antibodies against the avian influenza H5N1 virus.

Previously, the Vaccine and Bio-Technology Products Company No. 1 has announced their laboratory’s production of five batches equivalent to 100,000 dozes of H5N1 vaccine and has conducted animal testing on twenty monkeys. The results show that the monkeys’ immune system produces the appropriate antibodies after the vaccine was injected and all of the monkeys remained healthy, said Dr. Nguyen Thu Van, the company’s director. In addition, the tests performed on the first ten officials of the Institute of Hygiene and Epidemiology, who received two shots of H5N1 vaccine last month, showed positive results, she added. Dr. Van noted, however, that the previous experiments on monkeys and ten people are only a preparation for the large-scale human testing that began Saturday. If the Military Medical Institute’s testing proves to be successful, the H5N1 vaccine will be mass-produced by the middle of next year, she added.