Early Phase 1
N=24
Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT06837116 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Dengue IgG Level — 108.9; 104.0; 158.5; 143.2 RU/ml — p=< 0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prince of Songkla University
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dengue IgG Level |
108.9; 104.0; 158.5; 143.2; 148.6; 141.3 | < 0.01 sig |
| PRIMARY CD4 T Cell Responses |
22.0; 15.0; 137.5; 103.0; 98.5; 94.5 | — |
| PRIMARY CD8 T Cell Response |
5.0; 11.0; 62.0; 11.0; 6.0; 10.0 | — |
| SECONDARY All-Cause Mortality |
0; 0 | — |
| SECONDARY Serious Adverse Events |
0; 0 | — |
| SECONDARY Local Reactions |
3; 1 | — |
| SECONDARY Systemic Reactions |
0; 2 | — |
| SECONDARY Pain at Vaccination Site, 7 Day Post 1st Vaccination |
2; 1 | — |
| SECONDARY Erythema at Vaccination Site, 7 Day Post 1st Vaccination |
2; 0 | — |
| SECONDARY Malaise, 7 Day Post 1st Vaccination |
0; 1 | — |
| SECONDARY Headache, 7 Day Post 1st Vaccination |
0; 1 | — |
| SECONDARY Erythema at Vaccination Site, 7 Day Post 2nd Vaccination |
2; 0 | — |
Summary
Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study
Eligibility Criteria
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 products within 4 months before injection of investigational vaccines.
- Under anti-tuberculosis treatment.
- Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
Data sourced from ClinicalTrials.gov (NCT06837116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.