The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination
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|ClinicalTrials.gov Identifier: NCT04269265|
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : October 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Yellow Fever||Biological: Yellow Fever Vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 30, 2025|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: All Participants
In this single-arm study, all participants will receive the intervention
Biological: Yellow Fever Vaccine
YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Other Name: YF-VAX
- Peak Neutralizing Antibody Titer [ Time Frame: 18 months ]Peak titer of neutralizing antibody to yellow fever vaccination. Outcome reported as Log YF Antibody titer.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).
- If female of childbearing age must agree to contraception for one month following administration of the vaccination.
- History of yellow fever or previous vaccination for yellow fever
- Known bleeding disorder
- Prior surgery complicated by clotting abnormality
- Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study
- History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein).
- Thymus disorder associated with abnormal immune function
- Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy.
- Pregnant or breastfeeding at the time of vaccination.
- Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269265
|Contact: Kevin Escandon, MD, MScemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Timothy Schacker, MD 612-626-6577 firstname.lastname@example.org|
|Joint Clinical Research Centre||Not yet recruiting|
|Kampala, Uganda, 10005|
|Principal Investigator:||Timothy Schacker, MD||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
U01AI141981 ( U.S. NIH Grant/Contract )
|First Posted:||February 13, 2020 Key Record Dates|
|Last Update Posted:||October 21, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Body Temperature Changes
Vector Borne Diseases
RNA Virus Infections
Hemorrhagic Fevers, Viral