Sanofi Pasteur’s dengue vaccine candidate completes efficacy study in Latin America

Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase III efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8 per cent* of dengue disease cases in children and adolescents nine to 16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes.*

Additional observations of the results showed a clinically important reduction by 80.3 per cent* in the risk of hospitalisation due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever (DHF), the severe form of dengue1, which is consistent with the results released from Sanofi’s phase III dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.
 
Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events SAEs) during the study showed similar reporting rates between the vaccine and control groups and are consistent with the favourable safety profile documented in previous studies (phase I, II, III).

A full analysis of the efficacy and safety data from the phase III study will be completed and reviewed by external experts before publication in a peer-reviewed scientific journal and presentation at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting, to be held from November 2 to 6, 2014, in New Orleans, Louisiana, US.

“For the first time ever, after 20 years of research and industrial commitment, dengue is set to become a vaccine preventable disease,” said Olivier Charmeil, President and Chief Executive Officer, Sanofi Pasteur. “The data generated from our comprehensive research and clinical programme involving 40,000 children, adolescents and adults from 15 countries, will be submitted to the health authorities in countries where dengue is a public health priority.”

“These compelling phase III results demonstrate the efficacy and good safety profile of this vaccine candidate against dengue. For the first time, we have a vaccine candidate that has the potential to offer protection to people who are at risk of dengue,” commented Dr Rivaldo Cunha, MD, Infectious Disease Specialist, Associate Professor, Faculty of Medicine Universidade de Mato Grosso do Sul, Brazil, and a principal investigator in the study.
 
“These new positive phase III results from Latin America are very encouraging because they are consistent with the results reported in July in the Asian phase III trial. Together, the results of these trials suggest that for the first time, a vaccine solution that can help control dengue, is on the horizon,” commented Professor Duane Gubler, Professor and Founder of the Signature Research Program on Emerging Infectious Diseases, Duke-NUS Graduate Medical School, Singapore, and Chairman of the Partnership for Dengue Control.

*95 percent CIs overall efficacy [52.0 per cent, 68.0 per cent]; Efficacy per serotype (ST1 50.3 per cent, ST2 42.3 per cent, ST3 74 per cent, ST4 77.7 per cent); 95 per cent CIs reduction of the risk of hospitalization [64.7 percent, 89.5 per cent]

References

1. World Health Organization (WHO). Dengue guidelines for diagnosis, treatment, prevention and control. Available at:

http://www.who.int/tdr/publications/documents/dengue-diagnosis.pdf. Published 2009. Accessed March 24, 2013.

2. World Health Organization (WHO). Global strategy for dengue prevention control: 2012-2020. Available at:

http://reliefweb.int/sites/reliefweb.int/files/resources/9789241504034_eng.pdf. Published 2012. Accessed April 3, 2014

3. PAHO May 2014 http://www.paho.org/hq/index.php?option=com_content&view=article&id=9657&Itemid=1926

4. WHO Dengue and severe dengue Fact sheet N°117 Updated March 2014. Available at http://www.who.int/mediacentre/factsheets/fs117/en/

EP News Bureau-Mumbai