Vietnam plans to start its first human trial of a locally-made H5N1 bird flu vaccine as early as next month, using 20 to 30 volunteers, said health officials in the communist country. The drug trial, to be carried out with US government technical assistance, will be the latest of several global efforts to develop a vaccine for mass production, with research also going on in the United States, Europe and Asia.
The news comes as a new wave of bird flu sweeping Vietnam has killed a 20-year-old man, infected four other people and triggered more than 100 poultry outbreaks nationwide since last month. "Preparations for the clinical test of a human vaccine have been basically completed," said Nguyen Tran Hien, director of the National Institute of Hygiene and Epidemiology (NIHE) in Hanoi.
"Twenty to 30 volunteers will be chosen to test an H5N1 vaccine produced in Vietnam." Hien said he expected testing to start as early as next month, pending health ministry approval, with the trial expected to wrap up next year. In the tests, subjects would not be exposed to H5N1 -- the viral strain that has killed 191 people worldwide since 2003 -- but would be given the vaccine to look for early evidence of safety and test their antibody response. US experts would provide technical assistance, said US Health Attache Michael Iademarco, adding Washington had granted one million dollars to Vabiotech, a company spun off from the institute.
The Vietnam trial is one of several efforts worldwide to find a vaccine that could be mass produced in case of a pandemic. Last month Indonesia's health ministry said US company Baxter Healthcare would in July start clinical trials of a bird flu vaccine in Singapore and Hong Kong, using a strain of the virus found in Indonesia. "There are many candidate vaccines, and some have been approved for stockpiling in emergency use," said Iademarco. But he said the long-term challenge was to "develop the capacity for rapid mass production."
The NIHE project is one of Vietnam's three research drives for a bird flu vaccine, along with work at the Pasteur Institute in Ho Chi Minh City and at the national vaccine producer IVAC in Nha Trang. In April the World Health Organisation (WHO) said Vietnam, Indonesia, Thailand, Brazil, India and Mexico would receive grants to produce flu vaccine locally and bolster global protection against a threatened pandemic. WHO's Vietnam chief Hans Troedsson said the UN body was "looking favourably" at a request to grant the IVAC project up to 2.5 million dollars.
Avian influenza has so far tended to infect people in close contact with H5N1-positive birds, but experts fear the virus could mutate to be more easily transmitted from human to human, triggering a global pandemic. Iademarco praised Vietnam for launching three different research projects in the search for a human avian influenza vaccine. "Each one of these three vaccines has a different background in biology, and I actually think it's smart that Vietnam is investing in three technologies at this early stage in research and development," he said. He cautioned that developing an H5N1 vaccine was a complex task. "It's not like seasonal flu where we can vaccinate 10,000 people and figure out if it's working or not," he said.
"The challenge with a pandemic influenza vaccination is that you have to work just as quickly, you don't have the experience behind you, and the consequences of failure are much higher." The trials would improve the skills of Vietnamese epidemiologists and help the country deal with future health threats, including dangerous new strains of the flu, Iademarco said. Vietnam's long-term goal, he said, "is to develop influenza vaccine capacity, because it's H5N1 today, but who knows what it's going to be tomorrow in terms of a virus with pandemic potential?"