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Dengue breakthrough: Lanka agrees to preventive vaccine trial
View(s):Sri Lanka is among 10 countries which will participate in a dengue vaccine development study.
A Memorandum of Understanding on this research collaboration to conduct the Phase 3 Clinical Trials for DENVax was signed this week between the Health Ministry and Takeda, a research-based global pharmaceutical company headquartered in Japan.
The Clinical Trials for DENVax, which is the second potential dengue vaccine produced in the world, have been launched as a collaboration between Japan and the United States of America. The US Food and Drug Administration (FDA) has approved the study design, which is modelled on the ‘Guidelines for the clinical evaluation of dengue vaccines’ — guidelines set out by the World Health Organization (WHO).
“The development of dengue vaccines is a globally important public health initiative,” Health Services Director General Dr. Palitha Mahipala told the Sunday Times, explaining that this research collaboration between Takeda and Sri Lanka would be overseen by the Epidemiology Unit and the Dengue Control Programme.
The Epidemiology Unit will set up a National Coordinating Committee chaired by its head, Dr. Paba Palihawadana, to oversee the research. The Epidemiology Unit is the body which sets out the National Immunisation Programme after consulting different experts and taking into account world trends.
The mandatory approvals from the National Medicines Regulatory Authority (NMRA) and an accredited Ethics Review Committee for the dengue vaccine study are awaited. The NMRA approval is essential prior to the proposed vaccine being given to anyone in Sri Lanka during the study, while it is also mandatory for ethical clearance to be secured to ensure the maintenance of ethical standards of practice in the research including the protection of the research participants.
The other countries which are part of the Phase 3 of this multi-centre Clinical Trial are Thailand, the Philippines, Vietnam, Colombia, Brazil, Panama, the Dominican Republic, Nicaragua and Peru. DENVax is said to offer protection against all four virus strains (serotypes) of dengue – DEN-1, DEN-2, DEN-3 and DEN-4, transmitted by the Aedes aegypti and Aedes albopictus mosquitoes. Usually, infection with any of the virus strains could lead to Dengue Fever or the deadly Dengue Haemorrhagic Fever.
In the first four months of this year alone, the Epidemiology Unit has reported more than 15,500 suspected cases of dengue with a death toll of 14. More than 52% of the cases have been reported from the Western Province. Pointing out that there is no treatment for dengue, only the management of the symptoms once someone gets dengue, Dr. Mahipala said a vaccine would help prevent dengue. “If a vaccine with proven benefits is developed, it will be important globally and for Sri Lanka.”
He said that with Sri Lanka’s collaboration in this research, when the vaccine is manufactured for distribution, the country would get the vaccine on a priority basis, as otherwise there may not be adequate stocks to go around when taking the dengue disease burden into account across the world.
The research collaboration with Takeda has come about due to the good surveillance systems in place for dengue in Sri Lanka and the local expertise available here, he said. Assuring that the safety of this vaccine has been tested before, Dr. Mahipala spoke of the benefits of vaccines which have led to the eradication and elimination of small-pox, polio, diphtheria and neonatal tetanus. Due to its vaccine, measles is near-elimination.
“Vaccines are one of the best public health interventions in disease control,” he added. More than 2,000 people have been part of the Phase 1 Clinical Trial for DENVax in the United States and Latin America and in Phase 2 in Puerto Rico, Colombia, Panama, the Dominican Republic, Singapore, Thailand and the Philippines which were large studies for the evaluation of safety and effectiveness.
The WHO, meanwhile, states that “there is a growing public health need for effective preventive interventions against dengue…. A safe, effective and affordable dengue vaccine against the four strains would represent a major advance for the control of the disease and could be an important tool for reaching the WHO goal of reducing dengue morbidity by at least 25% and mortality by at least 50% by 2020”.