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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    46
  • sponsor
    University of Minnesota
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Updated on 19 February 2024
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vaccination
immunosuppressive
yellow fever

Summary

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.

Description

The primary aim of this study is to determine the difference between antibody titers in the two study groups and study the relationship between endemic infections, IA, the FRCn, and CD4 and CD8 T cell subsets and the magnitude and durability of neutralizing antibody response to YFV in a cohort shown to have elevated IA, a damaged FRCn, and pan T cell depletion and a cohort that does not. This is a single arm, open-label, two cohort study of healthy adults in Kampala, Uganda and in Minnesota, USA. The cohort in Uganda will be 30 adults (15 men and 15 women) and the cohort in Minnesota will be 16 adults (8 men and 8 women). Everyone will be screened to ensure there are no contraindications to receiving YFV (e.g., immunosuppression) or the planned procedures. The inclusion and exclusion criteria are discussed in detail in the protocol that is included in the appendix. Participants will have an inguinal LN biopsy, leukapheresis, and GALT biopsies prior to YFV and again 3 weeks after the vaccine administration. The vaccine will be given in the contralateral thigh from the first LN biopsy so that the second biopsy will be from a draining LN. PBMC and plasma will be collected at regular intervals over the 18-month follow-up period and leukapheresis will be done again at the month 18 visit.

Details
Condition Yellow Fever Vaccine, Yellow Fever
Age 18years - 60years
Treatment Yellow Fever Vaccine
Clinical Study IdentifierNCT04269265
SponsorUniversity of Minnesota
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 the 2 months prior to vaccination and the month following

Exclusion Criteria

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 antidies targeting immune cells), previous radiation therapy
Pregnant or breastfeeding at the time of vaccination
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