Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
As in the setting of low- to middle-income countries, to demonstrating that lower doses of vaccine via intradermal route can still elicit robust immune responses, thereby lowering the overall cost of vaccination might be particularly meaningful ,with possible extra benefit of experiencing fewer side effects or risk of allergy. This study goal is to explores the potential of intradermal administration of Qdenga, hypothesizing that a lower dose via this route could achieve adequate immunogenicity compared to the standard subcutaneous administration, thus offering a cost-effective alternative particularly in low-resource settings where dengue is most prevalent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
29
Subcutaneous route vs Intradermal route
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Prince of Songkla university
Hat Yai, Changwat Songkhla, Thailand
Dengue IgG Level
To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination
Time frame: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
CD4 T Cell Responses
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
Time frame: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
CD8 T Cell Response
To measure T cell responses to dengue antigen by ELISpot on day 0, day 30 and day 120 after 1st vaccination.
Time frame: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
All-Cause Mortality
Death from any cause occurring from the first vaccination until the end of the 120-day follow-up period.
Time frame: at day 7 and 30 post each vaccination
Serious Adverse Events
Any untoward medical occurrence during the study period that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect, regardless of its relationship to the study vaccine.
Time frame: at day 7 and 30 post each vaccination
Local Reactions
\- Include any reported pain, swelling, erythema or nodule at the vaccination site
Time frame: at day 7 and 30 post each vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Systemic Reactions
fever, chill, fatique, headache, myalgia
Time frame: at day 7 and 30 post each vaccination
Pain at Vaccination Site, 7 Day Post 1st Vaccination
Injection-site pain reported during the 7-day period following the first vaccine dose.
Time frame: 7 day post 1st vaccination
Erythema at Vaccination Site, 7 Day Post 1st Vaccination
Erythema at vaccination site reported during the 7-day period following the first vaccine dose.
Time frame: 7 day post 1st vaccination
Malaise, 7 Day Post 1st Vaccination
Self-reported malaise during the 7-day period following the first vaccine dose.
Time frame: 7 day post 1st vaccination
Headache, 7 Day Post 1st Vaccination
Self-reported headache during the 7-day period following the first vaccine dose.
Time frame: 7 day post 1st vaccination
Erythema at Vaccination Site, 7 Day Post 2nd Vaccination
Erythema at vaccination site reported during the 7-day period following the second vaccine dose.
Time frame: 7 day post 2nd vaccination