An anti-diarrhoea vaccine containing a genetically modified bacterium is
to be tested on human volunteers.
The UK Department for the Environment, Food and Rural Affairs has given
the go-ahead for limited clinical trials after being advised that the use
of GM material presented a very low risk to the environment.
The prototype vaccine has been developed by the British bio-tech
company Acambis.
It is hoped that it will eventually lead to a vaccine which could save
thousands of lives in the developing world - and prevent people falling
ill on holiday.
The vaccine is based on a form of the E. coli bacterium, which is known
to cause about 40% of cases of travellers' diarrhoea.
The bug has been weakened by removing part of its genetic material.
This reduces its ability to cause illness, but not to trigger a
response by the immune system.
US experience
A similar prototype vaccine has already been through comparable
clinical trials in the United States.
The clinical trials will take place at Barts and The London NHS Trust.
Although the volunteers will excrete the vaccine in their faeces, it
will be destroyed by the sewage treatment system.
In addition, further genes have been inactivated so that the organisms
are less able to colonise the gut and survive in nature.
However, Becky Price, from the pressure group GeneWatch, said there was
evidence that another form of supposedly disabled E. coli could survive in
sewage systems.
She said better systems were required to monitor the impact of GM
organisms in the environment.
Diarrhoea is a major cause of death and serious illness in developing
countries.
Acambis estimates that a vaccine could potentially save the lives of
500,000 children a year in the developing world.
It also envisages that it could be available as a pre-holiday jab for
holidaymakers, possibly topped up once a year.
However, even if the trials prove to be successful, it is not
anticipated that a vaccine will be commercially available until 2008 at
the earliest.