Last updated 3 days ago

Evaluation of IXCHIQ® Vaccine Immunogenicity

75 patients around the world

Available in Brazil

Mauro Martins Teixeira

75Patients around the world

This study is for people with

Chikungunya

Requirements for the patient

To 59 Years

All Gender

Medical requirements

: The participant or guardian understands the procedures and requirements, and is willing and able to provide informed consent for full participation in the study.
Individuals of both sexes aged 12 to 59 years.

: Participants under 12 years of age or 60 years of age or older.
Those with any contraindication identified in Ministry of Health Technical Note No. 9/2026-CGFAM/DPNI/SVSA/MS (https://www.gov.br/saude/pt-br/centrais-de-conteudo/publicacoes/notas-tecnicas/2026/nota-tecnica-no-9-2026-cgfam-dpni-svsa-ms.pdf - Technical Note: Guidelines for monitoring the safety of the Chikungunya vaccine used during the pilot vaccination strategy in Brazil - 2026).
Participants unavailable to attend the planned study visits.
Participants who do not agree to sign the Informed Consent Form (ICF).
Positive β-hCG test on the day of vaccination, for women of reproductive potential.
Participants who are pregnant or planning to become pregnant within the 3 months following the vaccine dose.
Participants who are breastfeeding.
Participants with a known or suspected immune system defect that could influence the immune response to the vaccine, such as congenital or acquired immunodeficiency-including HIV infection, post-organ transplant status, or immunosuppressive therapy within 4 weeks prior to Visit 1. Immunosuppressive therapy is defined as the chronic administration of prednisone (more than 14 days) or an equivalent at a dosage of ≥2 mg/kg/day during the 4 weeks prior to study entry. Note: radiotherapy or cytotoxic immunosuppressive drugs/monoclonal antibodies within the previous 3 years; topical and inhaled steroids are permitted.
Any clinical instability identified by the attending physician that could place the participant at risk.

StudyIMUNO-CHIQ

SponsorMauro Martins Teixeira

Study typeInterventional

Conditions

Chikungunya

Requirements

To 59 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07846293