Deconstructing the protective immunity of yellow fever virus 17D to inform flavivirus vaccine design, Yellow4FLAVI – Colombian Component
| ISRCTN | ISRCTN49327404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49327404 |
| Secondary identifying numbers | CIEIH-1336 |
- Submission date
- 24/06/2024
- Registration date
- 28/06/2024
- Last edited
- 28/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
In areas where multiple flavivuruses are endemic, such as Colombia, serologic-based diagnosis of these viral infections is challenging due to cross-reactivity of human antibodies. These cross-reactive humoral responses can also result in different immunological outcomes of infections (affecting disease severity) or vaccination (affecting the quality of the elicited innate and humoral responses). The quality and dynamics of the human immune response to the yellow fever (YF) vaccine, YF17D, have been primarily characterized in inhabitants of regions that are non-endemic for other members of the Flaviviridae family. The extent to which pre-exposure to different flavivirus affects vaccine responses is unknown, and more so in endemic areas with overlapping circulation of multiple flaviviruses. In this project we will evaluate the systemic innate and adaptive response to YF vaccination (Stamaril) in a Colombian cohort of participants, residents of an urban metropolitan area endemic for Dengue virus, who seek YF vaccination for access to high risk YF areas.
Who can participate?
Healthy men or women between the ages of 25 and 59 years
What does the study involve?
Blood samples collected before and after YF vaccination will be analyzed for humoral and cellular surrogates of protection. Early antibody-dependent enahancement of innate responses will be explored in neutrophils.
What are the possible benefits and risks of participating?
Participants will not directly benefit from the results of this study. However, these results will generate important knowledge for the development of vaccines against other flaviviruses of public health importance such as dengue and Zika. Additionally, it will provide knowledge on effect of pre-exposure to dengue virus on the immune response to yellow fever vaccination, which is part of the Colombian program for extended immunization.
Due to the nature of the clinical procedures, this study represents a risk greater than the minimum according to Colombian guidelines (Resolution 8430 of 1993), and minimum risk according to international requirements (Code of Federal Regulations – Requirements 2018, Title 45, part 46 , USA). Since this is a project co-executed by CIDEIM and with collaborators in Europe, the international classification is accepted, with this study being designated as minimal risk.
Where is the study run from?
Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM (Colombia)
When is the study starting and how long is it expected to run for?
January 2024 to December 2028
Who is funding the study?
European Union - Horizon Europe
Who is the main contact?
Maria Adelaida Gómez, mgomez@cideim.org.co
Contact information
Public, Scientific, Principal Investigator
CIDEIM
Calle 18 # 122-135
Edificio O
Universidad Icesi
Cali
760008
Colombia
 ORCID ID |
0000-0001-8792-1563 |
|---|---|
| Phone | +57 6025552164 |
| mgomez@cideim.org.co |
Study information
| Study design | Single center observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | University/medical school/dental school, Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Deconstructing the protective immunity of yellow fever virus 17D to inform flavivirus vaccine design, Yellow4FLAVI – Colombian Component |
| Study acronym | Yellow4FLAVI-Colombia |
| Study objectives | Pre-exposure to Dengue virus (DENV) infection alters the innate and adaptive immune responses to vaccination against the yellow fever virus. |
| Ethics approval(s) |
Approved 31/05/2024, CIEIH (Calle 18 # 122-135, Edificio O, CIDEIM, Cali, 760008, Colombia; +57-602 5552164; ccollazos@cideim.org.co), ref: CIEIH-1336 |
| Health condition(s) or problem(s) studied | Healthy donors with and without prior history of dengue virus infections, who receive the yellow fever vaccine (YF17D). |
| Intervention | 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. The design will be an observational longitudinal clinical study that will include the following groups of participants: Group 1) People who wish to receive the yellow fever vaccine YF17D (Stamaril) Group 2) People not vaccinated against yellow fever. Samples obtained from unvaccinated people will be used for standardization processes of laboratory protocols. Pre-exposure to DENV will be evaluated by serological and neutralization tests. Following PAHO and Colombian guidelines for vaccination against yellow fever, participants will be immunized with the Stamaril vaccine. Samples and sampling time points will be as follows: pre-vaccination (D0-pre), 1h post-vaccination (D0-post), day 3 post-vaccination (D3), and D28 post-vaccination. For those with availability for additional follow-ups, two visits will be scheduled, one in D14 and another in year 1 post-vaccination (Y1). 100mL of peripheral blood will be obtained at each visit, except on D0, in which 150mL will be taken. Additionally, a complete medical examination will be performed and adverse reactions to the vaccine will be evaluated. Electronic data capture will be used to collect information and will be verified through clinical follow-up. Each visit will last approximately 1 hour. Innate and adaptive immune responses will be contrasted among study groups for samples collected each time point. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | F17D (Stamaril) |
| Primary outcome measure | Neutrophil, T cell and B cell response to YF17D measured by blood test at baseline, days 3 and 28 after vaccination |
| Secondary outcome measures | Neutrophil, T cell and B cell response to YF17D measured by blood test 14 days and 1 year after vaccination |
| Overall study start date | 01/01/2024 |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 59 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 01/07/2027 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Cali
760008
Colombia
Sponsor information
Research organisation
Calle 18 # 122-135
Edificio O
Universidad Icesi
Cali
760008
Colombia
| Phone | +57 602 5552164 |
|---|---|
| cideim@cideim.org.co | |
| Website | http://www.cideim.org.co/cideim/ |
"ROR" |
https://ror.org/003s20294 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Horizon Europe, Horizon Europe Programme, Framework Programme, Horizon Europe, EU Framework Programme, Horizon
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be stored in a non-publicly available repository (CIDEIM repository), and will be made available only upon request when the full dataset will be collected and analyzed, and contingen upon approval for use by CIDEIM IRB. Identifiable information will not be included in the study data or paper data collection forms (CRFs), electronic files, or the electronic database, except for identification card numbers necessary to identify individuals in the field, and to link data from consecutive study visits. These numbers will not be included in the data sets for analysis. All data will be stored in CIDEIM databases, complying with institutional guidelines for data management. For further information please contact Maria Adeladia Gómez at mgomez@cideim.org.co. |
Editorial Notes
25/06/2024: Trial's existence confirmed by CIDEIM
