Can a single shot shield children from chikungunya?
NCT ID NCT06106581
First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This trial is testing whether a single injection of an experimental chikungunya vaccine, VLA1553, is safe and triggers a protective immune response in healthy children aged 1 to 11 years. About 300 children will receive either a full dose, a half dose, or a control vaccine. The study aims to find the right dose for this age group, potentially paving the way for a pediatric chikungunya vaccine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a live-attenuated chikungunya virus vaccine candidate called VLA1553, given as a single injection at full or half dose
- What this could lead to
- If successful, this could help protect children against chikungunya, a painful mosquito-borne viral disease, potentially leading to a pediatric vaccine.
- What could go wrong
- This is an early-phase trial, so the vaccine may not produce a strong enough immune response or could cause side effects. Results in children may differ from adults.
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.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
304 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
-
Jul 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 11 years
- Sex
-
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: 1. Male or female healthy children aged 7 to 11 years for Stratum A, 3 to 6 years for Stratum B and 1 to 2 years for Stratum C at the time of vaccination; 2. Written informed consent by the participant's parent(s)/Legally Acceptable Representative(s) ((LAR(s)), according to local requirements, and written informed assent of the participant, if applicable; 3. Participant was seropositive for previous CHIKV exposure (i.e., IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e., IgM-/IgG-); or participants with any borderline IgM or IgG element (IgM borderline/IgG-, IgM-/IgG borderline, or IgM borderline/IgG borderline were mapped to seronegative group; participants with enzyme-linked immunosorbent assay (ELISA) result IgM borderline/IgG+ were mapped to seropositive group); Exclusion Criteria: 1. Participant was IgM+/IgG- does not qualify for participation in this trial. 2. Participant was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical trial involving an investigational CHIKV vaccine; 3. Participant had an acute or recent infection (and was not symptom-free in the week prior to the Screening Visit (Visit 0)) 4. Participant had received another live virus vaccine within 28 days or inactivated vaccine (includes messenger ribonucleic acid \[mRNA\] vaccines) within 14 days prior to vaccination in this trial or planned to receive a live virus vaccine within 28 days or inactivated vaccine within 14 days after vaccination; 5. Participant had abnormal findings in any required trial investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which posed a risk for participation in the trial based on his/her judgment; 6. Participant had an ongoing medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions (e.g., cardiovascular, respiratory, neurologic, psychiatric, or rheumatologic conditions) that posed a risk for participation in the trial, based on Investigator's clinical judgment. Examples included individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment, or presence of high-risk comorbidities (e.g., significant cardiopulmonary disease); 7. Participant had a history of immune-mediated or clinically relevant arthritis/arthralgia; 8. Participant had a known or suspected defect of the immune system that could be expected to influence the immune response to the vaccine, such as Participants with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno- suppressive therapy within 4 weeks prior to Visit 1. Immunosuppressive therapy was defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥0.05 mg/kg/day within 4 weeks prior to trial entry, radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years; topical and inhaled steroids were allowed. 9. Participant had a history of any vaccine-related contraindicating event (e.g., anaphylaxis, allergy to components of the vaccine or the control vaccine, other known contraindications including febrile convulsions); 10. Participant presented with clinical conditions representing severe bleeding disorders and medications interfering with blood clotting; 11. Participant received blood-derived products (e.g. plasma) within 180 days prior to vaccination in this trial; 12. Participant had participated in another clinical trial involving an investigational medicinal product (IMP) or device within 30 days prior to vaccination or was scheduled to participate in another clinical trial involving an IMP, or device during the course of this trial; 13. Participant had any condition that, in the opinion of the Investigator, could compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial; 14. Participant/ Participant's parent(s)/LAR(s) was/were a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships included close relatives (i.e., children, partner/spouse, siblings, parent(s)/LAR\[s\]) as well as employees of the Investigator or site personnel conducting the trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chikungunya virus infection are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Fundacion Dominicana de Perinatologia Fundacion Probebe
Santo Domingo, Gazcue, Dominican Republic
-
Instituto Dermatologico y Cirugia de la Piel "Dr Huberto Bogaert Diaz" IDCP
Santo Domingo, 10306, Dominican Republic
-
Inversiones en Investigacion Medica INVERIME
Tegucigalpa, Honduras
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Chikungunya vaccines face Real-World test in island outbreaks
- Chikungunya Vaccine's Long-Term shield put to the test
- New rapid test could speed up tropical fever diagnosis
- Chikungunya vaccine safety checked in pregnant women
- New chikungunya vaccine enters first human safety trial
- Brazilian pilot program tests chikungunya Vaccine's Real-World power