Dengue Vaccine Hesitancy Among International Travelers

February 18, 2025 updated by: Thundon Ngamprasertchai, MD, Mahidol University

The goal of this cross-sectional study is to study dengue vaccine hesitancy among 390 international travelers who visit the Hospital for Tropical Diseases, Bangkok, and three public sites which are the area near the Grand Palace, Khaosan Road, and the snake farm at Queen Saovabha Memorial Institute. The main question it aims to answer is what are the factors associated with the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand.

Participants will do the questionnaire consists of three parts

  1. Questionnaire to estimate vaccine hesitancy on each 5 domains.
  2. Knowledge about dengue infection and vaccination
  3. Demographics data of the participants The study prioritizes ethical considerations, confidentiality, and data management to ensure participant welfare and data security.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Dengue, a disease caused by the flavivirus and characterized by four distinct serotypes, stands as a substantial public health concern, with an estimated 390 million infections occurring worldwide annually. Clinical manifestations range from mild febrile illness to severe dengue, with secondary infections carrying a heightened risk due to antibody-dependent enhancement (ADE). The incidence of dengue among travelers to endemic areas is around one percent monthly, influenced by factors like exposure duration, seasonality, and traveler activities. Despite lacking a specific treatment, vaccination has emerged as a promising preventative measure. However, the initial vaccines licensed in the market have demonstrated limited efficacy. Vaccination in a naïve population has been associated with an increased likelihood of severe disease during the initial natural dengue infection. The recently licensed second dengue vaccine requires further information before comprehensive guidelines for usage in travelers can be established.

The rise of vaccine hesitancy, marked by reluctance or refusal, poses a growing concern, potentially leading to low vaccine coverage and emerging outbreaks. The literature about dengue vaccine hesitancy is very scarce because, unlike measles or COVID-19(CoronaVirus Disease of 2019), the efficacy of the dengue vaccine does not prove itself as a highly recommended option to prevent the disease. However, the controversial incident with the first dengue vaccine seemed to embed significant hesitation in both dengue and other vaccinations as well. Furthermore, proactive preparation for the prospective integration of the dengue vaccine into the national immunization program or its designation as a recommended vaccine for travelers is also crucial. This research aims to determine dengue vaccine hesitancy and its associated factors among non-endemic international travelers visiting Thailand, providing valuable insights for future vaccine recommendations and discussions.

Objectives:

  1. To study the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand.
  2. To assess the factors associated with the dengue vaccine hesitancy among non-endemic international travelers visiting Thailand.

Methodology:

The cross-sectional study will recruit 390 international travelers who visit the Hospital for Tropical Diseases, Bangkok, and three public sites which are the area near the Grand Palace, Khaosan Road, and the snake farm at Queen Saovabha Memorial Institute. Data collection involves a one-time gathering of information, with eligible participants willing to provide informed consent. The questionnaire can be done both paper-based and online-based (JOTFORM), which takes time around 10-15 minutes. The questionnaire consists of 3 main parts including, a question assessing dengue vaccine hesitancy, knowledge about dengue vaccination, and demographic data. The questionnaire for estimating dengue vaccine hesitancy was derived from previous literature and validated with the pilot cohort of 20 participants. The study prioritizes ethical considerations, confidentiality, and data management to ensure participant welfare and data security.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Thailand
    • Ratchathewi
      • Bangkok, Ratchathewi, Thailand, 10400
        • Hospital For Tropical Diseases

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Male and female international travelers from dengue-non-endemic countries
  • Age ≥18 years old
  • Able to read and understand English questionnaire
  • Willing to participate in the study Endemic countries of dengue will be defined as all countries in the ASEAN(Association of Southeast Asian Nations) economic community countries, Central and South American countries except Chile, and ten countries in Eastern Mediterranean and Africa showing high frequency of dengue transmission according to WHO(World Health Organization) and ECDC(European Centre for Disease Prevention and Control) data(Yemen, Egypt, Sudan, Eritrea, Djibouti, Tanzania, Kenya, Ethiopia, Somalia, Burkina Faso). Non-endemic countries refer to all the other countries apart from endemic countries.

Exclusion Criteria

  • Travelers who are visiting the hospital for dengue vaccination or dengue infection or dengue-like symptoms, which is defined as acute fever with one of the following; rash, myalgia, headache, nausea, vomiting, retro-orbital pain.
  • Participants who are expatriate workers or lived in Thailand or other Southeast Asia countries for more than 1 year.

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-endemic international travelers
Other: Questionnaire
Adapted design questionnaire to estimate the vaccine hesitancy specifically for dengue vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dengue vaccine hesitancy score
Time Frame: Baseline
Spectrum of the dengue vaccine hesitancy score will be assessed by the 15 items questionaire with 7 likert scales adapting from 5C determinants of the vaccine hesitancy. The score ranging from 3-45 for each 5 domains. Higher score will represent stronger impact for each determinants; the positive determinants are confidence and collective responsibility while negative determinants are constraints, complacency, and calculation.
Baseline

Collaborators and Investigators

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

Sponsor

Mahidol University

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 (Actual)

June 1, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUTM-2024-030-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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