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Results of Phase III Trial on Dengue Vaccine in Latin America (CYD15) has been published in NEJM

5 November 2014

The Phase III trial on the clinical safety and efficacy of a novel tetravalent dengue vaccine conducted in Latin America (CYD 15) is published in the New England Journal of Medicine. These results are consistent with the results of the Phase III multicentre study conducted in Asia (CYD14). With this information, 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 2015.

CYD15 was a randomized, observer-masked, and controlled trial involving 20,869 healthy participants aged 9 to 16 years from dengue endemic areas of Brazil, Colombia, Mexico, Honduras and Puerto Rico. They received 3 doses of either vaccine or placebo, allocated in a 2:1 ratio.

The primary endpoint was met with an overall efficacy of 60.8% (CI: 52% ;68%) against virologically-confirmed dengue after receiving 3 doses  [per protocol population(PP)]. In those receiving at least one dose of the vaccine [intention to treat (ITT) population], the overall VE was 64.7% (95% CI: 58.7;69.8).

Serotype-specific VE (PP) was observed against all Dengue Serotype including against DEN-2 with the following details:

  • DENV1: 50.3% (95%CI: 29.1;65.2);
     
  • DENV2: 42.3% (95%CI: 14.0; 61.1);
     
  • DENV3: 74.0% (95%CI: 61.9;82.4);
     
  • DENV4: 77.7% (95%CI: 60.2;88.0).
 
VE against hospitalized dengue cases due to any serotype (ITT) was 80.3% (95%CI: 64.7;89.5) during the 25-month study period. VE against severe dengue (1997 WHO Criteria) was 95.5% (95% CI: 68.8;99.9) in the ITT population.

The safety profile was comparable with that of placebo, and no safety signals were detected during the observation period, consistent with CYD14.

The accumulated data on the CYD-TDV vaccine from Phase I, II and III studies have now involved more than 40,000 volunteers. This is the first dengue vaccine to complete Phase III evaluation. As you know, the first of these two Phase III trials, CYD 14 is already published in The Lancet in July 2014.

The NEJM has made the publication access free. Due to the journal’s copyrights, please click here to read the article.


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