Creating and studying a group of yellow fever-vaccinated individuals to discover factors affecting the immune response to vaccination and acute viral infections

Not Applicable

Completed

• Conditions: The condition under investigation is the immune response to yellow fever vaccination in healthy individuals.; Infections and Infestations

• Registration Number: ISRCTN17974967
• Lead Sponsor: udwig Maximilian University of Munich

Brief Summary

2023 Preprint results in https://www.biorxiv.org/content/10.1101/2023.05.07.539594v1.full.pdf (added 24/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-28
• Study Start: 2023-08-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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

1. Pregnant or lactating women
2. Previously received a yellow fever vaccination
3. Pre-existing flaviviral diseases such as dengue fever or West e 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

Study & Design

• Study Type: Observational
• Study Design: Not specified