Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers (NCT06837116) | Clinical Trial Compass
CompletedEarly Phase 1
Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers
Thailand29 participantsStarted 2025-04-19
Plain-language summary
Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Thai adult aged 18-60 years, who not previously received dengue vaccine.
* The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 3-month follow-up of the study.
* Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
* The subject can provide with informed consent and sign informed consent form
Exclusion Criteria:
* Have a medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
* Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
* Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
* Have acute infectious diseases, including dengue infection
* Have severe chronic diseases or condition in progress cannot be controlled. For example, poor controlled DM and uncontrolled HT.
* Have the history of urticaria 1 year before receiving the investigational vaccine.
* Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
* Have needle sickness.
* Have the history of immunosuppressive therapy, cytotoxic therapy or systemic corticosteroids
* Have received blood produ…
What they're measuring
1
Dengue IgG Level
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
2
CD4 T Cell Responses
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)
3
CD8 T Cell Response
Timeframe: Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)