Summary

Name:

ChimeriVax-Dengue

Synonyms:

ChimeriVax Dengue

Sponsor:

Sanofi Pasteur

Co-Sponsor:

Acambis (acquired by Sanofi Pasteur)

Type of product:

Vaccine

Viral family:

Flaviviridae

Status:

Phase IIa
Evaluated as tetravalent vaccine; Development initiated at Acambis

ChimeriVax-Dengue 

Synonyms:ChimeriVax Dengue       Sponsor:Sanofi Pasteur       Co-Sponsor:Acambis (acquired by Sanofi Pasteur)       Type of product:Vaccine       Mode of action:Recombinant, viral expr vector       Viral family:Flaviviridae       Virus:Dengue virus      

Details

Characteristics:
Live chimeric vaccine for Dengue Virus, tetravalent (Dengue viral serotypes DEN-1 to 4 included in vaccine);
 
Produced in vitro using Vero cells without serum;

Based on recombinant Yellow Fever Virus (strain 17D) expressing envelope gene from Dengue Virus

In vivo and clinical data:
Phase I trial done with only DEN-2 viral serotype showed induction of neutralising antibodies in over 95% of vaccinees to homologous vaccine strain or to wild-type Dengue Virus serotype 2;
  
Phase I of tetravalent vaccine, completed in 2005, confirmed high-level seroconversion;
 
Phase II results were presented at Sanofi Pasteur Research & Development Meeting on Sept. 17, 2007, and at 56th Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), Philadelphia, PA, in Nov. 2007:
  • Immunization with tetravalent vaccine induced seroneutralizing antibody response against all 4 serotypes of Dengue virus in 100% of US trial participants
  • No serious adverse events were reported

 

Results published in early 2010 (Morrison et al., J Infect Dis 201[3]: 370-377, Feb. 2010) showed that all participants seroconverted against all 4 serotypes after receiving 3 doses at 0, 4, and 12-15-months, and almost all seroconverted after 2 doses given 8-11 months apart; No SAEs related to vaccine were reported

Development status

Phase IIa
Evaluated as tetravalent vaccine; Development initiated at Acambis

Remarks

Recombinant vaccine for Dengue Virus;
 
Acambis developed individual vaccines and performed Phase I trials;
 

Sanofi Pasteur has exclusive rights on vaccine and assumes current development of vaccine;

 

Phase II pediatric trial (healthy children 4 to 11 years old) ongoing in Thailand (Province of Ratchaburi), with collaboration from Mahidol University of Thailand, Ministry of Public Health of Thailand, and Pediatric Dengue Vaccine Initiative (PDVI);

Multicenter Phase II study ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, Vietnam, Philippines, Singapore, Thailand