Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers

NCT06837116 | Completed Early Phase 1 Results

• 1 other identifier: REC.67-475-14-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

Official title: Immunogenicity of an intradermal Qdenga vaccine among healthy volunteers: A pilot study

Conditions

Dengue

Keywords

Safety; Immunogenicity; intradermal Qdenga

Outcome Measures

Primary Outcomes (3)

• Dengue IgG Level

  To measure Antibody level for dengue by ELISA on day 0, day 30 and day 120 after 1st vaccination

  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.

  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.

  Day 0 (Baseline), Day 30 (30 days post 1st vaccination) and Day 120 (30 days post 2nd vaccination)

Secondary Outcomes (9)

• All-Cause Mortality

  at day 7 and 30 post each vaccination

• Serious Adverse Events

  at day 7 and 30 post each vaccination

• Local Reactions

  at day 7 and 30 post each vaccination

• Systemic Reactions

  at day 7 and 30 post each vaccination

• Pain at Vaccination Site, 7 Day Post 1st Vaccination

  7 day post 1st vaccination

Study Arms (2)

SC ID

ACTIVE COMPARATOR

subcutaneous Qdenga for 1st vaccination then intradermal Qdenga for 2nd vaccination

Biological: Vaccine

SC SC

ACTIVE COMPARATOR

subcutaneous Qdenga for 1st vaccination then subcutaneous Qdenga for 2nd vaccination

Biological: Vaccine

Interventions

Vaccine BIOLOGICAL

Subcutaneous route vs Intradermal route

SC ID; SC SC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (2)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Prince of Songkla university

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Dengue

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Limitations and Caveats

This pilot study is limited by small sample size, short follow-up, and lack of neutralization assays and detailed T-cell phenotyping. These factors restrict interpretation of durability, serotype-specific responses, and immune correlates. Larger studies with extended immunologic assessments are planned.

Results Point of Contact

• Title: Tawin Khaimook
• Organization: Prince of Songkla university

tawin.khaimook@gmail.com

+66846912946

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Sarunyou Chusri M.D. Ph.D.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: April 19, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)