Adimmune kicks off human trials for A(H1N1) vaccine
The China Post news staff Saturday, September 26, 2009, 11:08 am TWN
Sole local vaccine manufacturer Adimmune Corp. will begin human testing of the A(H1N1) vaccine today or tomorrow, and an assessment of its effectiveness could be expected in three weeks time, health officials said yesterday.
The clinical trials will be held at National Taiwan University Hospital (NTUH), Tri-Service General Hospital and Wan Fang Hospital, with 150 adult participants, ages 18 and above, set to receive inoculation, officials were cited as saying.
The immune response from a single dose of vaccine will be seen by mid-October, before the same group of volunteers receives the second booster shot, officials added.
Huang Li-min, the head of pediatric infectious diseases department at NTUH who also doubles as the doctor overseeing the clinical trials, said that if over 70 percent of the group develop protection against the novel virus, the vaccine will be considered effective.
According to Adimmune, only until it is verified that the adult participants do not come down with fever, or develop severe swelling on the spot where shots were given, will testing on the 100 children, 17 and under, begin at NTUH.
The manufacturer is still recruiting candidates from the younger demographic, reported the Central News Agency (CNA).
Adimmune has thus far rallied 480 people willing to partake in the study, sometimes entire families stepping forward to stand in as guinea pigs for the new vaccine, the report said.
Huang said many adults offered their services after media reports of participation by reputed experts such as the former health minister Chen Jian-jen and honorary professor Lee Ching-yun.
Due to ethical regulations, however, which mandate volunteers remain anonymous, Chen and Lee were refused participation, Huang remarked.
Meanwhile, the seasonal vaccination campaign will commence Oct. 1, and the A(H1N1) vaccination campaign should follow suit in November, local media said.
Almost three million seasonal vaccine shots are available this year, and the government has purchased 10 million of A(H1N1) vaccine from Adimmune and another five million from Swiss pharmaceutical company Novartis.
According to the order of priority groups as stipulated Department of Health (DOH), there will be approximately two million people who will be administered both the seasonal and A(H1N1) vaccines.
Given that children require two seasonal vaccine shots for protection, not to mention the likelihood of the new A(H1N1) vaccine requiring two shots to produce immune response, there will be individuals, many of them young, who will be given three or four shots this flu season, said the CNA.
Several clinical studies of the new vaccine conducted in the United States and in Australia have shown adults showing strong immune responses following a single low dose A(H1N1) vaccine.
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