Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418854
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-08
Brief Title:
Dengue Vaccine Hesitancy Among International Travelers
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Dengue Vaccine Hesitancy Among International Travelers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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-19CoronaVirus 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
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-19CoronaVirus 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None