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Dengue vaccine study aims to unlock immune secrets
NCT ID NCT07158190
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at how the Takeda dengue vaccine (TAK-003) activates T-cells, a key part of the immune system. Researchers will vaccinate 30 healthy adults and analyze their T-cell and antibody responses over 26 weeks. The goal is to find reliable markers of protection, which could improve future dengue vaccines and help prevent severe disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TAK003 (live attenuated tetravalent dengue vaccine)
- What this could lead to
- If successful, this could identify immune markers that predict protection, helping improve dengue vaccines and reduce severe disease risk.
- What could go wrong
- This is a small, early-stage study (30 participants) focused on immune responses, not on proving the vaccine works. Results may not apply to larger populations or real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2024
- Expected to finish
-
Sep 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals who have never contracted the dengue infection and individuals who have previously been confirmed dengue seropositive through laboratory analysis.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fondazione Policlinico Universtiario Agostino Gemelli IRCCS
Rome, Roma, 00168, Italy
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Other studies related to the condition(s) this trial covers.
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