Posted on 02/16/2006 11:02:45 AM PST by blam
US to test child bird flu vaccine
Children are particularly susceptible to influenza
What may be the first clinical trial of a vaccine against the deadly strain of bird flu in children is set to take place in the US. Scientists in St Louis want to test the vaccine, made from an inert form of the potentially lethal H5N1 virus, on 120 children aged between two and nine.
Centre for Clinical Vaccine Control experts say there is no risk and warn the young are more vulnerable to flu.
News of the trials emerged as the virus reached birds in Austria and Germany.
On Thursday, EU vets announced agreed to boost measures to prevent the spread of bird flu, increasing exclusion zones to 6.5m (10km) from one mile (1.6km) around affected areas, plus additional buffer zones.
Experts are working to develop a vaccine which could be used if a flu pandemic occurred.
It is believed the most likely way for this to happen would be if the H5N1 virus combined with a human flu.
The vaccine being tested in the US is made from a strain of the virus found in Vietnam.
It has already been tested by the National Institutes of Health on adults at clinical sites in the US.
Director of the centre in St Louis Dr Robert Belshe said it was crucial a vaccine was designed particularly for children as they are more susceptible to flu and have a different pattern of immune response to adults.
It is also thought that children are a key link in diseases spreading to pandemic proportions.
His team is currently recruiting for the study funded by the National Institute of Allergy and Infectious Diseases.
Stockpile?
Around 150 children die from influenza in the US each year so designing a vaccine that protects them will be a key step in the fight against any bird flu virus that might mutate to spread between humans.
Dr Belshe told the BBC there was no need to be concerned about the welfare of the children in the trial as any possible side-effects were very small and consisted of a sore arm and low grade fever that could be easily treated.
He said: "We are confident that what we are doing is safe and it yields a lot of information on how to give the bird flu vaccine should we need it."
The vaccine is grown in hens' eggs, with one egg per dose, and there are concerns that it may not be possible to create enough of it to treat all the youngsters that may be affected should a flu pandemic arise.
Professor John Oxford, a virology expert at Barts and the London Queen Mary's School of Medicine and Dentistry, said many pharmaceutical companies were trying to create an H5N1 vaccine.
"People are concentrating on this disease like never before."
He said there was disagreement among scientists about whether vaccines protecting against existing strains of the H5N1 virus should be created and stockpiled.
This is because many experts believe it would be better to wait and create a vaccine based on the exact type of virus that emerges in any future flu pandemic.
"I am in the group which things we should stockpile a vaccine and then modify it if and when a pandemic happens.
"It's seems to be sensible to try to go on what we have got now and indeed the government has already bought 2m doses H5N1 vaccine," he said.
Dr Jim Robertson, principal scientist at the UK's National Institute for Biological Standards and Control, said clinical trials of bird flu vaccines were being carried out around in the world, in China, Japan and Europe.
But he said he thought the US trial would be the first time a vaccine had been tested in children.
Children used as guinea pigs. Dispicable.
Since when has every vaccine on the market been trial tested on humans? Did they trial test the morning after pill on teenagers? I certainly doubt it.
Since the first person you give it to is always a defacto trial test. Just because a vaccine works on an animal doesn't mean it'll work on a human; just because a vaccine doesn't hurt an adult doesn't mean it won't hurt a child. If children were never used as "guinea pigs", there'd never be vaccines for kids.
Okay, I agree you are probably right. But it sounds to me like they are skipping Phase I and going right to Phase II.
What are clinical trial phases?
Clinical trials of experimental drugs proceed through four phases:
In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV studies are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effects associated with long-term use.
By the way I believe the hype over bird flu is a money makers scam and there is no way I would ever give permission for my child to be a guinea.
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