Dengue vaccine out soon
2011/06/11
By Chandra Devi Renganayar
chandra@nst.com.my
Final trials starting thismonth
KUALA LUMPUR: A dengue vaccine developed by theHealthMinistry and a private company is expected to be available soon,with the final phase of clinical trials to start thismonth.
Thismuch anticipated vaccine, said to be the first in theworld, is set to
become amedical breakthrough.
While there are a fewongoing vaccine development programmes, there has so far been no tested and approved vaccine for the dengue virus.
Director-general ofHealthDatukDr Hasan Abdul Rahman told theNew Sunday Times that the latest phase, the third,would target 1,500 subjects in Kuala Lumpur and Penang.
The trials are jointly conducted by theministry and Sanofi-Pasteur, the vaccine division of pharmaceutical giant Sanofi-Aventis.
"Similar studies are being undertaken in Thailand, Indonesia, the Philippines and Vietnam. Because the scope is wide, we have broken it up into several trials."
It is understood that the first and second phase of clinical trials have yielded positive results.
While the primary sites are in Kuala Lumpur and Penang, Dr Hasan said smaller scale trials of the same study were also being conducted in the state hospitals of Perak, Negri Sembilan and Sarawak.
The University Malaya Medical Centre is also involved in the study.
Currently there is no specific treatment for the mosquito-borne disease. Until the vaccination is made available, destroying the breeding grounds of Aedes mosquitoes remain the primary means of preventing dengue fever.
In view of the public health threat, the ministry had rolled out many campaigns to raise awareness and to curb the spread of the disease.
These included the "10-minute a week" campaign encouraging the public to set aside 10 minutes in a week to clean their houses and remove possible mosquito breeding areas.
However, Dr Hasan said there is a "laissez-faire attitude" among the public when it comes to clean-up projects.
Although there is high awareness of dengue prevention practices among the public, many are reluctant to participate in community clean-up projects
"Even as early as 2006 when the ministry conducted the National and Health Morbidity Survey, we found that many were aware of dengue prevention practices. About 82 per cent were knowledgeable on dengue transmission but only 14 per cent participated in community clean-up projects in their area.
"In fact, 21.4 per cent were never involved in such activities. More recent findings from community feedback also show a similar trend, that is, the knowledge is high but action is limited."
The public, Dr Hasan said, must realise that it is up to them to ensure the breeding places of Aedes mosquitoes are eliminated.
"It is impossible for the Health Department to check every single house in the country," he added.
The country recorded 45,901 cases last year, a 12 per cent increase and 134 people died from the disease.
For the last five months of this year, 8,496 dengue cases were reported with 13 deaths recorded.
An increase in the number of dengue cases were seen in Penang, Kuala Lumpur, Malacca, Sabah and Pahang.
Sanofi-Pasteur hopes to launch the vaccine in four years' time for priority countries with 100 million doses annually.
While dengue vaccine development has been undertaken by other research institutions and pharmaceutical companies, Sanofi-Pasteur's vaccine is the only one that has targeted the four different dengue viruses, said Dr Jean Lang, associate vice-president at Sanofi-Pasteur's global department of research and development.
"We were the first to invest in the R&D for a dengue vaccine in the 1990s and today this vaccine is the world's most clinically advanced dengue vaccine candidate.
"The scientific challenge was to choose the right approach to have a well tolerated vaccine that offers protection against the four serotypes of the dengue virus," he said.
Fifteen endemic and non-endemic countries have been included in the company's global clinical study programme which includes Malaysia, Thailand, Australia, Singapore, Vietnam, the Philippines, Mexico and Puerto Rico.
Globally, 45,000 participants will be included in the clinical study programme.
Dr Lang said Phase I and 2 of clinical studies among children and adults have been evaluated in the United States, Asia and Latin America and efficacy results from a Thai study is expected to be available at the end of next year.
"We have observed positive results in our clinical trials. A balanced immune response against all four serotypes was observed after three doses of the vaccine.
"The vaccine is well tolerated with similar safety profile after each dose.
"We have no doubts that we will be the first to roll out the dengue vaccine within a few years."
About 2.5 billion people are at risk in over 100 countries.
An estimated 220 million people are infected annually and about two million, mostly children, develop dengue haemorrhagic fever.
Dr Lang acknowledged that it would be a challenge to make it accessible to everyone at risk.
In response to this global need for a dengue vaccine, the company is building a new vaccine production centre in France, he said.
It is intended to reduce the time necessary to provide access to the vaccine once it is licensed.
The centre is expected to be operational in 2014.
Dr Lang also said implementation of dengue vaccination programmes would face challenges.
"Creating vaccination policies as well as dealing with access and financing mechanisms for people most in need must be looked at.
"It is crucial for the public health community to work together to start preparing for vaccination programmes. We are collaborating with international groups such as the Dengue Vaccine Initiative to raise awareness and move dengue vaccination higher on the global health agenda," said Dr Lang.
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