Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies

Dengue Clinical Trial

Official title:

Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05213364
• Other study ID #: Dengue_VaxHes
• Status: Not yet recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Dengue

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