The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination

Completed · Phase 1/Phase 2

Conditions studied: Yellow Fever

In brief

Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response.

Key facts

Study ID

NCT04269265

Run by

University of Minnesota

People needed

43

Starts

2020-07-01

Expected to finish

2023-10-23

Last updated by the study team

2025-10-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States
• Joint Clinical Research Centre — Kampala, Uganda

Full record on ClinicalTrials.gov

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