Development Of Meningococcal Vaccine To Begin
Development of a vaccine to combat New Zealand's ongoing epidemic of meningococcal disease is underway following the signing of a contract between the Ministry of Health and biotechnology company Chiron Corporation.
In developing the vaccine, specific to the strain of meningococcal group B bacterium responsible for the NZ epidemic, Chiron will be collaborating with the Norwegian National Institute of Public Health (NIPH).
The Norwegian involvement reflects Norway's experience in developing a vaccine to combat an epidemic of a different strain of group B meningococcal disease in the 1990s.
The Californian-based Chiron Corporation also has experience in development of vaccines for the prevention of various groups of meningococcal disease, including development and licensure of MenjugateTM - which was used in a universal vaccination campaign to prevent meningococcal disease in the United Kingdom. This vaccine has also been approved for use in Canada, Ireland and Hungary.
Director-General of Health Dr Karen Poutasi welcomed the contract as a highly significant first step in reducing the toll the disease takes on New Zealanders, but cautioned there was still a lot more work to be done.
"Anyone who has had a family member contract meningococcal disease knows what an aggressive and frightening illness it can be. It's frightening enough even to think your sick child's symptoms could be those of meningococcal disease," Dr Poutasi said.
"New Zealand is now in the eleventh year of an epidemic which has affected the lives of thousands of people. I am absolutely delighted that after years of research, discussion and collaboration with experts in New Zealand and internationally we have now reached this point."
"However it is only the starting point. We are talking about developing a tailor-made vaccine, which is a complex and lengthy process, with the possibility of setbacks at many different stages. While this is an extremely promising first step it is important to recognise that it is just that."
Although the strains of meningococcal disease in New Zealand and Norway are both typed as group B there are subtle differences in the make up of the bacterium, which means a unique vaccine is required for each strain.
Development of the Norwegian vaccine involved in total 225,000 people. Any vaccine targeting the New Zealand strain would be tested in New Zealand, according to international guidelines on vaccine development and monitoring of participants. This includes assessment from the Standing Committee on Therapeutic Trials (SCOTT) and regional ethics committees.
An initial clinical study will be with a small number of people in New Zealand. The clinical study will be overseen by a team consisting of the University of Auckland, Chiron and the Ministry of Health. Further detail regarding timing of this study is still to be confirmed.
"We know that meningococcal disease causes more hospitalisation and fatalities than any other notifiable infectious disease in New Zealand. The human cost for those who survive is significant - the disabling effects can include limb amputations, massive skin grafts or brain damage.
"From 1 January 2001 to 20 July there have been 296 cases of meningococcal disease, resulting in the death of 15 people. The estimated social cost of the disease is $75 million a year. This includes hospital/rehabilitation costs of about $29 million a year. Availability of a safe and effective vaccine could significantly reduce this cost as well as control the epidemic."
Dr Poutasi said that until a vaccine was widely available in New Zealand, people needed to be aware of the signs and symptoms and to seek medical treatment early.
"Symptoms in a very young child can include a fever and vomiting, or the child may refuse drinks or feeds, be excessively sleepy, or cry and be unsettled. A rash like blood spots under the skin may also appear at a later stage. It is important that the child see a doctor, as early treatment helps save lives."
For more information contact: Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277 5411 http://www.moh.govt.nz/media.html
Who will be participating in the initial study? Details are yet to be finalised, however it will involve volunteers who are willing to participate in the study.
What does the initial clinical study involve? The clinical study will be overseen by a team consisting of the University of Auckland, Chiron and the Ministry of Health. Further details, including the number of volunteers are yet to be finalised. However, there are national and international guidelines regarding clinical studies which must be met. The prime focus of these guidelines is the safety of volunteers in the study. The guidelines cover issues ranging from production, vaccine quality, guidelines of selection criteria for volunteers, ethics approval, monitoring and auditing. Before any study can proceed, ethics approval is required, as well as approval from the Ministry of Health.
Details of the guidelines are documented in the publication New Zealand Regulatory Guidelines for Medicines Volume 3: Interim Good Clinical Research Practice Guidelines August 1998. A full copy of this can be found on the Medsafe website www.medsafe.govt.nz.
When will the general public be involved in studies? The general public are not involved in the initial study. Introduction of studies in the wider population is still some years away.
How much is the initial study costing New Zealand? That is not known at this point, and is still subject to negotiation.
What happens once the initial clinical study is complete? The next steps will be determined pending the outcome of the study. Details of this initial study are yet to be finalised.
How much is further study likely to cost? That is not known at this point and will be further investigated pending the outcome of the initial study. We do know that the estimated social cost of the disease is $75 million a year. This includes hospital/rehabilitation costs of about $29 million a year. Availability of a safe and effective vaccine could significantly reduce this cost as well as control the epidemic.