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NEJM publishes results of phase III clinical study of dengue vaccine candidate

Lyon (France): Results of final landmark phase III efficacy clinical study of Sanofi Pasteur’s dengue vaccine candidate has been published in The New England Journal of Medicine.

According to Sanofi Pasteur, the vaccines division of Sanofi, the overall efficacy against any symptomatic dengue disease was 60.8 per cent in children and adolescents 9-16 years old who received three doses of the vaccine. Analyses show a 95.5 per cent protection against severe dengue and an 80.3 per cent reduction in the risk of hospitalization during the study.

The results of this second phase III efficacy study confirm the high efficacy against severe dengue and the reduction in hospitalization observed during the 25-month active surveillance period of the first phase III efficacy study conducted in Asia, highlighting the consistency of the results across the world.

Safety analyses (solicited reactions, unsolicited events and serious adverse events) during the study showed similar reporting rates between the vaccine and control groups and are consistent with the favourable safety profile observed during the 25-month active surveillance period of the previous efficacy study conducted in Asia.

Sanofi Pasteur’s phase III efficacy clinical study programme for its dengue vaccine candidate was conducted in over 31,000 participants across 10 endemic countries in Asia and Latin America.

Sanofi Pasteur will file for registration of its vaccine candidate and, subject to regulatory approval, the world’s first dengue vaccine could be available in the second half of 2015.

“We plan to submit the vaccine for licensure in 2015 in endemic countries where dengue is a public health priority,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “Our goal is to help meet the WHO’s objectives to reduce dengue mortality by 50% and morbidity by 25% by 2020.”

Dengue is a threat to over 2.5 billion people, nearly half the world’s population, and is a pressing public health priority in over 100 countries in the Americas and in Asia. Every year, an estimated 500,000 people, including children, are hospitalized due to severe dengue, which puts a huge strain on healthcare systems particularly during outbreaks. Dengue has dramatically increased over the past 30 years with an acceleration over the last decade due to travel and urbanization.

“Until now, we were only able to provide supportive care for patients with dengue. On the strength of the outcome of this phase III efficacy study, we hope this will become an effective preventive measure against dengue,” said Dr Rivaldo Cunha, infectious disease specialist, associate professor, faculty of medicine, Universidade de Mato Grosso do Sul, Brazil, and a principal investigator in the study. “I will welcome a dengue vaccine that can prevent the personal suffering of severe disease and hospitalization.”

The primary objective of the phase III study in Latin America and the Caribbean was to assess the efficacy and safety of the Sanofi Pasteur dengue vaccine candidate after three vaccinations in preventing symptomatic virologically-confirmed dengue cases.

A total of 20,869 children aged 9 to 16 years from dengue endemic areas of Brazil, Colombia, Mexico, Honduras and Puerto Rico participated in the study and were randomized to either receive three injections of the dengue vaccine or a placebo (2 to 1 ratio) at 0, 6, and 12 months.

Two pivotal phase III efficacy studies involved more than 31,000 volunteers from Asia (Indonesia, Malaysia, the Philippines, Thailand and Vietnam) and Latin America and the Caribbean (Brazil, Colombia, Honduras, Mexico and Puerto Rico).

The phase III evaluations provide pivotal data on efficacy, safety, and immunogenicity of the vaccine candidate in a broad population and different epidemiological environments and assess the potential impact of the vaccine on the disease burden.

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