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Deconstructing the protective immunity of yellow fever virus 17D to inform flavivirus vaccine design, Yellow4FLAVI – Colombian Component

Deconstructing the protective immunity of yellow fever virus 17D to inform flavivirus vaccine design, Yellow4FLAVI – Colombian Component

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN49327404
Enrollment
120
Registered
2024-06-28
Start date
2024-09-19
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy donors with and without prior history of dengue virus infections, who receive the yellow fever vaccine (YF17D). Infections and Infestations

Interventions

In this observational study, the innate and adaptive immune response to YF vaccination will be evaluated in a Colombian cohort of participants, residents of an urban metropolitan area endemic for DENV

Sponsors

Centro Internacional de Entrenamiento e Investigaciones Medicas
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Vaccinees: 1. Men or women between the ages of 25 and 59 years 2. Completion of the process and signing of informed consent 3. Availability to carry out follow-up visits at least D3 and D28 4. Intention to get vaccinated against YFV 5. No contraindications for vaccination against YF according to the MinSalud survey applied in the vaccination service Unvaccinated: 6. Men or women between the ages of 25 and 59 years 7. Completion of the process and signing of informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant women identified by rapid urine test or who are breastfeeding. This population will not be included because pregnancy induces changes in the immune system, which introduce an important confounder for the analysis of the results. 2. Previous vaccination against yellow fever manifested orally or with evidence of a vaccination card. 3. Known allergies to eggs or their components. 4. Temperature >38°C on the day of recruitment into the study 5. Acute illness (with or without fever) on the day of study recruitment. 6. Vaccination against another infectious agent less than 30 days before yellow fever vaccination 7. History of use of immunosuppressants or immunomodulatory drugs. 8. History of previous or suspected immune dysfunction. These include, but are not limited to: liver disease, diabetes mellitus and immunodeficiencies, thyroid disease, vitiligo, cancer, diabetes, HIV infection, rheumatoid arthritis, thymus disease, (includes thymectomy), renal or chronic failure, psoriasis, diseases autoimmune, multiple sclerosis, myastheniagravis, thymus tumor or removal. 9. History of known anaphylactic or allergic reactions. 10. Administration of immunoglobulins or blood products three months before vaccination or planned during the study 11. Be receiving current treatment for any infectious disease 12. History of tumoral diseases.

Design outcomes

Primary

MeasureTime frame
Neutrophil, T cell and B cell response to YF17D measured by blood test at baseline, days 3 and 28 after vaccination

Secondary

MeasureTime frame
Neutrophil, T cell and B cell response to YF17D measured by blood test 14 days and 1 year after vaccination

Countries

Colombia

Contacts

Public ContactMaria Adelaida Gómez
mgomez@cideim.org.co+57 6025552164

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026