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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05213364
Other study ID # Dengue_VaxHes
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2022
Est. completion date November 2023

Study information

Verified date January 2022
Source Fundacion GESICA
Contact Patricia Angeleri, MD
Phone 541141239000
Email pangeleri@intramed.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Among all arboviruses, Dengue (DEN) is the vector borne disease with the highest burden worldwide. Around 390 million infections per year are estimated, of which around 96 million are clinically apparent. Since its re-emergence in 1998 in Argentina, DEN has shown an epidemic behavior affecting mainly the northern and central regions in which the circulation of serotypes has been heterogeneous. The last significant outbreak was registered between the end of 2019 and the beginning of 2020.. Vaccine development for DEN prevention has been a long and challenging journey. The only vaccine that has reached registration to date is a recombinant attenuated tetravalent vaccine (Dengvaxia, Sanofi Pasteur) showing an efficacy against virological confirmed DEN infection of 36.6% (4.2-61.4) in seronegative subjects at baseline and 77.9% (65.1-86.0) in seropositive. However, this vaccine has not been pre qualified by the World Health Organization. New dengue vaccines are in advanced stages of development worldwide. At least three vaccines are in advanced stages of development including one produced by Takeda, the Butantan Institute and the Merck, Sharp & Dohme development. The implementation of a vaccination strategy in Argentina could be a health-relevant approach. However, the best way to implement this requires prior information describing and investigating numerous aspects of vaccination including acceptability. A systematic review of two acceptability surveys showed an acceptability of 77% to 86% but in countries with endemic DEN at time of the surveys. It is possible that in Argentina, the introduction to the regular calendar, for use in specific regions with a high and periodic burden of disease, of highly effective and safe DEN vaccines will be considered. However, to our knowledge, we do not have available evidence of the potential acceptability of these vaccines. The main objectives of this research will be: To evaluate the acceptability of a DEN vaccine in potential target populations in regions of high burden of disease in Argentina. Describe main determinants of and barriers to DEN vaccine acceptability in regions of high burden of disease in Argentina. Identify information and intervention needs to design and implement communication strategies that have a positive impact on the acceptability of a DEN vaccine.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date November 2023
Est. primary completion date August 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - People who express willingness to participate and who are residents of communes with a high burden of Dengue disease. Exclusion Criteria: - Persons who do not give informed consent.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundacion GESICA

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of subjects who express acceptability to the DEN vaccine. Baseline (time 0)
Primary Proportion of subjects who express acceptability to the DEN vaccine. At 12 months
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