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

January 26, 2022 updated by: Fundacion GESICA

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals aged 18 years or older, residing in one of the three districts with the highest burden of NDD in Argentina who provide written informed consent to participate in the survey.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who express acceptability to the DEN vaccine.
Time Frame: Baseline (time 0)
Baseline (time 0)
Proportion of subjects who express acceptability to the DEN vaccine.
Time Frame: At 12 months
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion GESICA

Investigators

  • Study Chair: Patricia Angeleri, MD, Fundación GESICA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (ACTUAL)

January 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dengue_VaxHes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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