The condition under investigation is the immune response to yellow fever vaccination in healthy individuals. Infections and Infestations
Conditions
Interventions
The yellow fever vaccination with the attenuated YF17D virus is a model system to examine the individual immune response of adult participants exposed to a viral infection under controlled conditions.
plasma and serum samples are used to analyze the cytokine and antibody response and the kinetics of replication of the vaccine virus. The study also aims to characterize the immune response of individ
Sponsors
Ludwig Maximilian University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female individuals between the ages of 18 and 55 years old 2. Healthy with no acute infections or chronic diseases 3. Women must have a negative pregnancy test 4. Willingness to provide written informed consent after being thoroughly informed of the risks and benefits of the study 5. Availability for all study time points (i.e., able to attend all study visits)
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Previously received a yellow fever vaccination 3. Pre-existing flaviviral diseases such as dengue fever or West Nile virus infection 4. Known allergies to egg or egg components or aminoglycosides 5. A temperature greater than 38°C on the day of study entry or an acute illness (with or without fever) on the same day 6. Receipt of any other vaccination less than 30 days before the study 7. A history of autoimmune diseases or immunosuppression 8. Known anaphylactic or allergic reactions 9. Using unregistered drugs or drugs in clinical trials 10. Clinically significant mental illness 11. Receipt of immunoglobulins or blood products within three months of the study or are planning to do so during the study 12. Injection drug users 13. Ongoing tumor diseases 14. Past or current manifestations of haematological, renal, hepatic, pulmonary, CNS, cardiovascular, or gastrointestinal diseases 15. Anyone deemed by the investigator to not be compliant with the study objectives and protocol 16. A foreseeable absence from the study center during the study period, such as due to a planned vacation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude and durability of the immune response to the yellow fever vaccine measured by developing and validating a novel method to quantify neutralizing antibodies against the yellow fever virus in participants 14 and 28 days after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Inter-individual variability in antibody response measured by comparing the robustness of the immune response among individuals after vaccination 2. Correlation of biomarkers with vaccine response measured by identifying biomarkers, such as lymphocyte count at day 7 and basophil absolute count, that correlate with the magnitude of the immune response 3. Characterization of peripheral blood mononuclear cells (PBMCs) measured using high-dimensional immunophenotyping with a spectral analyzer, which may provide insight into individual immune responses 4. Evaluation of the cytokine response and the kinetics of vaccine virus replication measured using plasma samples from participants | — |
Countries
Germany
Outcome results
None listed