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HANOI: 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 $ million 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 start in July 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 Organization (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 favorably” at a request to grant the IVAC
project up to $2.5 million.
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
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.
--AFP
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