Sanofi Pasteur, the vaccines division of Sanofi, has announced that its tetravalent dengue vaccine candidate demonstrated proof of efficacy against dengue, a threat to almost three billion people, in the world’s first ever dengue efficacy trial conducted in Thailand, with excellent safety.
The vaccine generated antibody response for all four dengue virus serotypes. Evidence of protection was demonstrated against three of the four virus serotypes circulating in Thailand. Analyses are ongoing to understand the lack of protection for the fourth serotype in the particular epidemiological context of Thailand.
Results of this first efficacy trial with Sanofi Pasteur’s dengue vaccine candidate represent a key milestone in the quest to develop a safe and efficacious human vaccine against dengue. This is also an important development for global public health, since there is currently no specific treatment or prevention for dengue. We are fully committed to making dengue a vaccine preventable disease by bringing a safe and effective vaccine to people living in endemic regions of the world,” said Michel De Wilde, Executive Vice President, Research and Development, Sanofi Pasteur.
Importantly, the results confirm the excellent safety profile of the vaccine candidate. The full data resulting from this first efficacy trial are currently under review by scientific and clinical experts, as well as public health officials. Detailed results of this study will be published in a peer-reviewed journal and presented to the scientific community later this year.
Large scale phase III dengue vaccine clinical studies with 31,000 participants are underway in 10 countries of Asia and Latin America. These studies will generate important additional data in a broader population and in a variety of epidemiological settings to demonstrate vaccine efficacy against the four circulating dengue virus serotypes.
The study was conducted in 4,002 children aged 4 to 11 years, in partnership with the Mahidol University under the patronage of the Thai Ministry of Public Health in Muang district of the Ratchaburi Province. Sanofi Pasteur dengue vaccine candidate is a live attenuated vaccine. The vaccination schedule is three doses given six months apart (at zero, six and 12 months).
EP News Bureau