Status:
ACTIVE_NOT_RECRUITING
Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda).
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Dengue
Eligibility:
All Genders
18-65 years
Brief Summary
Dengue is one of the most epidemiologically and clinically relevant arboviral diseases, affecting half of the global population. This disease is caused by one of the four serotypes of the dengue virus...
Detailed Description
Inclusion criteria: Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests; availability for the duration o...
Eligibility Criteria
Inclusion
- Women/Men aged between 18 and 65 years old; generally in good health, confirmed through a medical history questionnaire and basic laboratory tests;
- availability for the duration of the study, approximately 26 weeks after vaccination;
- willingness to sign an informed consent form, acknowledging understanding of the objectives, procedures, and risks associated with the stud
Exclusion
- current pregnancy or breastfeeding;
- recent hospitalization or serious illness in the past four weeks;
- evidence of clinically significant neurological, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease based on medical history, physical examination, and/or laboratory studies;
- behavioral, cognitive, or psychiatric disorders that, in the opinion of the investigator, impact the participant's ability to understand and comply with the study protocol;
- laboratory values of grade 1 or higher for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine as defined in the protocol;
- any other condition that, in the opinion of the investigator, could compromise participant safety or rights in the study or make the participant unable to follow the protocol;
- significant alcohol or drug abuse in the past 12 months resulting in medical, occupational, or family problems, as indicated by the participant's history;
- history of severe allergic reaction or anaphylaxis;
- severe asthma (emergency room visit or hospitalization in the past 6 months);
- current viral infection;
- use of anticoagulant medications;
- use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days before or after vaccination. Immunosuppressive dose of corticosteroids is defined as equal to or greater than 10 mg of prednisone equivalent per day for equal to or greater than 14 days;
- receipt of a live vaccine within 28 days or an inactivated vaccine within 14 days prior to vaccination, or expected receipt of any vaccine within 42 days after vaccination; asplenia;
- receipt of blood products in the past 6 months, including transfusions or immunoglobulins, or expected receipt of any blood product or immunoglobulin within 42 days after vaccination.
Key Trial Info
Start Date :
June 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07158190
Start Date
June 30 2024
End Date
September 30 2025
Last Update
September 5 2025
Active Locations (1)
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1
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
Rome, Roma, Italy, 00168