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Vietnam starts human trials for bird flu vaccine   2008-04-04 - Reuters

Vietnam has started clinical trials for developing a human vaccine for the H5N1 virus, researchers said on Thursday in the Southeast Asian country that has recorded 52 deaths from bird flu.

 
Dr. Nguyen Tuyet Nga (R), head of the high tech division of the Vietnam's Vaccine and Biological Production No. 1 company vaccinates a volunteer at a human vaccine trial for bird flu H5N1 virus in Hanoi April 3, 2008  
Vietnam has started clinical trials for developing a human vaccine for the H5N1 virus, researchers said on Thursday in the Southeast Asian country that has recorded 52 deaths from bird flu.

Eleven volunteers, all researchers, received their second dosage of the trial vaccine on Thursday inside spotlessly-clean medical rooms of a company run by the National Institute of Hygiene and Epidemiology in Hanoi.

Dr Nguyen Tuyet Nga, the epidemiologist and virologist heading the clinical trial, said researchers were using the highly-pathogenic strain of H5N1 taken from humans in 2004 in Vietnam and known as VN1194.

The strain is being studied worldwide by scientists in their quest for a vaccine for the bird flu virus that has killed 238 people globally out of 376 confirmed cases since 2003, according to the World Health Organization.

"I think this is complicated but very important work and we have some support from outside experts," Nga said. "We will test it for cross-protection in a later clinical trial but not now."

She said the U.S. Centers for Disease Control and the World Health Organization (WHO), a United Nations agency, had helped with project development, but there was no foreign pharmaceutical partner.

The dosages for the clinical trial range from 3.75 micrograms to 45 micrograms per dose and two doses 28 days apart, Nga said. She said there were no boosters planned for the trial.

"We'll see how long protection lasts," Nga said after receiving a dosage and administering it to other volunteers wearing white or green medical coats and blue surgical caps at the company known as Vabiotech.

"It feels and looks like any other vaccine," said Hoang Anh Duc, 25, one of the volunteer researchers.

Last month, a military official said the Vietnam Ministry of Health had approved another trial to start later in April at the Military Medical Academy in Ha Tay province near Hanoi.

Researchers at Vabiotech, or Company for Vaccine and Biological Production No.1, said on Thursday that up to 30 military personnel were expected to volunteer for that trial once it was approved by the Ministry of Defense.

WHO in Vietnam said it was not directly involved in Vietnam's development of a human vaccine for the H5N1 virus, but was satisfied that health authorities had rigorous guidelines for quality control.

GlaxoSmithKline said last month that a vaccine it designed to protect people against H5N1 may be effective in warding off a few different sub-types of the virus.

A vaccine designed using a current H5N1 strain might not offer protection against other strains and might even be useless in any eventual pandemic because viruses mutate all the time.

Still, experts say the process of making vaccines will lay down the necessary infrastructure so that the time used to make an eventual pandemic vaccine -- anywhere between 4 to 6 months after a pandemic begins -- can be shortened.


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