DengueNCT05213364
Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies
An observational study of Dengue, run by Fundacion GESICA.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dengue
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- People who express willingness to participate and who are residents of communes with a high burden of Dengue disease.
Who cannot join
- Persons who do not give informed consent.
Trial locations and contacts
No sites are listed yet.
Cristian Biscayart, MD contact
About this study
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..
Read more
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.
- Conditions
- Dengue
- Keywords
- Vaccine Hesitancy
- Medical subject headings
- Dengue, Vaccination Hesitancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who express acceptability to the DEN vaccine.
Measured: Baseline (time 0)
Proportion of subjects who express acceptability to the DEN vaccine.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startApr 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion GESICA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Angeleri, MD, Study chair, Fundación GESICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213364
- Sponsor's protocol ID
- Dengue_VaxHes
- Status last verified
- Jan 2022
- First submitted
- 26 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dengue Vaccine Hesitancy and Acceptance in Endemic Regions of Argentina: Impact of Communication Strategies
- ClinicalTrials.gov ID
- NCT05213364
- Acronym / sponsor ID
- Dengue_VaxHes
- Conditions
- Dengue
- Keywords
- Vaccine Hesitancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fundacion GESICAUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- People who express willingness to participate and who are residents of communes with a high burden of Dengue disease.
Key exclusion criteria (1 listed)
- Persons who do not give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of subjects who express acceptability to the DEN vaccine.
Time frame: Baseline (time 0)
Proportion of subjects who express acceptability to the DEN vaccine.
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Biscayart, MD contact
Patricia Angeleri, MD study chair
Fundación GESICA
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue, run by Fundacion GESICA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Angeleri, MD (541141239000 ext. 3220, pangeleri@intramed.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who express acceptability to the DEN vaccine. (time frame: Baseline (time 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.