Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers: A Pilot Study

Launched by PRINCE OF SONGKLA UNIVERSITY · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers," is looking to evaluate how well a new dengue vaccine works when given through a method that involves injecting it just under the skin. The study is aimed at healthy adults aged 18 to 60 years in Thailand who have never received a dengue vaccine before. To participate, individuals should be in good health and able to commit to following the study for three months.

Participants will receive the vaccine and will be monitored for any reactions or side effects, as well as how effectively their bodies respond to the vaccine. It's important to note that certain individuals, such as those with specific medical conditions, allergies to vaccine components, or women who are pregnant or breastfeeding, will not be eligible to join the trial. This study is still in the early stages and is not yet recruiting participants, but it aims to help researchers understand how well this new vaccine could protect against dengue fever.

Gender

ALL

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.