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With a horizon in sight on a dengue vaccine, its maker Sanofi Pasteur is preparing for the final leg of its trials in India, as well.
“We have recently completed the Phase II study and are planning to conduct a Phase III study in India, which is a safety and immunogenicity study in a large age group,” said Stephan Barth, India Head - Sanofi Pasteur.
On Tuesday, Sanofi had said that it would register the product, the world’s first dengue vaccine, in endemic countries in 2015.
“We have competed the Phase II study amongst 189 adult subjects across five sites in India, namely - Delhi, Ludhiana, Bangalore, Pune and Kolkata,” Barth said, responding to queries from BusinessLine .
Safety, immunogenicity study
The Phase III study currently planned in India is a safety and immunogenicity study across a large age group (ie children, adolescents, and adults populations) with 18 month study duration, he added.
“As soon as the clinical trial protocol is finalised, we will submit it to the relevant authority for approval and will be in a position to start the Phase III study in India. This is a requirement before the vaccine is registered and eventually launched in the Indian market,” he explained.
Dengue vaccine candidate
Sanofi Pasteur’s dengue vaccine candidate is the most clinically and industrially advanced dengue vaccine candidate in development, the company said. Over 40,000 volunteers participated in its dengue vaccine clinical study programme (phase I, II and III), it added.
Dengue cases across the country are increasingly being reported putting pressure on an already saturated public health infrastructure. According to Health Ministry estimates, over 13,900 cases were reported till end-September 2014.
The vector-borne disease (transmitted by mosquitoes) had dramatically increased over the past 30 years with an acceleration over the last decade due to travel and urbanisation, the Sanofi note said.
India benefits
Sanofi Pasteur would make the vaccine available in India and support a comprehensive vaccination programme to help meet the World Health Organsiaiton’s objective of reducing dengue mortality by 50 per cent and morbidity by 25 per cent by 2020, Barth said.
While no details were available on how Sanofi would price the product, the company said that the vaccine would be produced at its new vaccine manufacturing facility in Neuville-sur-Saône, France.
Health priority
Dengue is a health priority in several countries of Latin America and Asia where epidemics occur regularly, the note said. And the WHO estimates that there are up to 100 million infections per year, though the overall number of people infected with dengue globally is not fully known.
The WHO has set the goal of estimating the true public health burden of dengue by 2015, the note said, adding that the burden of dengue is generally underestimated.
Severe dengue, also known as dengue haemorrhagic fever, is a potentially deadly complication due to plasma leakage, fluid accumulation, respiratory distress, severe bleeding, or organ impairment, the note explained.
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