Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.

Launched by BUTANTAN INSTITUTE · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study the safety and effectiveness of giving two vaccines—one for dengue and one for chikungunya—at the same time, compared to giving them separately. Both dengue and chikungunya are viral infections that can cause fever and other symptoms. The trial will involve adults aged 18 to 59 who have not been previously exposed to either virus.

To participate, individuals must be healthy adults within that age range and able to provide consent. However, those with certain medical conditions, recent vaccinations, or a history of severe allergies may not be eligible. Participants in the trial can expect to receive either the combined vaccines or the separate ones, and their health will be monitored to see how well the vaccines work and if there are any side effects. Importantly, this trial is not yet recruiting participants, so interested individuals will need to wait until it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female adults aged 18 to 59 years at the time of vaccination.
• • 2. Signed informed consent by the participant or their legal representatives.
• • 3. Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.
• Exclusion Criteria:
• • 1. Participation in another clinical trial within 28 days prior to screening or planned participation in another clinical study during the trial period.
• • 2. Pre-existing unstable health condition. An unstable health condition is defined as a disease requiring a change in treatment or hospitalization due to disease worsening within 90 days prior to screening.
• • 3. Vaccination within 14 days prior to screening with any inactivated vaccine or within 28 days prior to screening with any live attenuated vaccine, or planned vaccination with any vaccine up to 28 days after study vaccination.
• • 4. Known hypersensitivity to any component of the vaccines.
• • 5. Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.
• • 6. Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.
• • 7. Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: Clinical conditions (including but not limited to renal failure, liver failure with cirrhosis, heart failure class III or IV according to the New York Heart Association, HIV infection, and asplenia).
• • 8. Use of systemic corticosteroids (oral, intravenous, or intramuscular) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 days or a cumulative dose greater than 280 mg within the last 90 days prior to screening. Topical, inhaled, and intranasal corticosteroids are allowed. Intermittent use (a single dose within the last 30 days prior to screening) of intra-articular corticosteroids is also allowed.
• • 9. Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.
• • 10. Malignancy at the time of screening or a history of malignancy with \<5 years of disease-free status at screening (except for basal cell carcinoma of the skin and localized prostate cancer under active surveillance).
• • 11. Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.
• • 12. Being part of the study team, having a first-degree relative (parents, children, in-laws, stepchildren, sons-in-law, or daughters-in-law) or living in the same household as a study team member.
• • 13. Any other clinical condition that, in the investigator's opinion, may interfere with the study results or pose an additional risk to the participant due to study inclusion.
• • 14. Prior exposure to dengue and chikungunya viruses, i.e., non-reactive IgM and IgG as screened by specific ELISA for both viruses. In case of doubt or indeterminate ELISA results, at least two consecutive samples will be collected. If doubt persists after two test collections, the participant will be excluded.
• • 15. For female participants of childbearing potential: Pregnancy (confirmed by a positive β-hCG test), breastfeeding, or intention to engage in sexual activity with reproductive potential without using a contraceptive method for 90 days following vaccination.
• • 16. Previous receipt of any dengue or chikungunya vaccine.