400 Thai Volunteers To Be Involved In Second Phase Of Flu Vaccine Trials

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400 volunteers to be involved in second phase of flu vaccine trials

By Pongphon Sarnsamak

The Nation

BANGKOK: -- The second phase of human trials of the typeA (H1N1) vaccine, involving 400 volunteers, will be held soon and the results are expected to known by September, Dr Wichai Chokewiwat, chairman of the the Government Pharmaceutical Organisation (GPO) said.

The GPO is now recruiting volunteers for the second phase of the flu vaccine trials. So far, 50 people have signed up but only 10 volunteers are allowed to receive the nasal flu vaccine as the researchers found the others had a medical record of contracting the flu virus and the hepatitis virus.

The second phase will be conducted at the Faculty of Tropical Medicine of Mahidol University.

Researchers will divide the volunteers into three groups: the first group will comprise volunteers aged 1218; the second group will comprise those aged 1849 and the last group will be in the 4960 range. Each group will receive vaccine doses of 7.5 log while one volunteer in four will receive a placebo vaccine.

The GPO's first phase of human trial was tested on 24 volunteers. A Japanese expert, one of the Data and Safety Monitoring Board, told to Wichai that the result of the human trial phase 1 was safe.

Wichai said the GPO expected to register the flu vaccine with the Food and Drug Administration by September, if it could succeed to develop this live attenuated vaccine.

"Now we can stabilise this vaccine when it is sprayed into the nose," he said.

In a related development, the GPO is now also looking forward to test the avian influenza A (H5N1) vaccine against the birdflu virus as the GPO has seen an increase in the severity of the H5N1 virus.

At present, Vietnam has already started phase 1 of the H5N1 virus vaccine testing, supported by the World Health Organisation (WHO).

The GPO will produce the H5N1 live attenuated vaccine as it is easier to produce than an inactivated vaccine.

GPO is considering seeking a Bt30million budget for the trials, which is currently supported by a Bt60million WHO grant.

The GPO has now speeded up construction of its manufacturing facility for the vaccine in Saraburi province's Tab Khwang district. The factory is expected to be finished in the next two years.

-- The Nation 2010-05-12

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