NCT04269265

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2020

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

February 11, 2020

Results QC Date

August 11, 2025

Last Update Submit

September 17, 2025

Conditions

Yellow Fever

Outcome Measures

Primary Outcomes (1)

  • Peak Neutralizing Antibody Titer

    Peak titer of neutralizing antibody to yellow fever vaccination. Outcome reported as Log YF Antibody titer.

    18 months

Study Arms (1)

All Participants

EXPERIMENTAL

In this single-arm study, all participants will receive the intervention

Biological: Yellow Fever Vaccine

Interventions

Yellow Fever VaccineBIOLOGICAL

YF-VAX®, Yellow Fever Vaccine, for subcutaneous use

Also known as: YF-VAX
All Participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Joint Clinical Research Centre

Kampala, 10005, Uganda

Location

MeSH Terms

Conditions

Yellow Fever

Interventions

Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Kevin Escandon, MD MS
Organization
University of Minnesota
escan012@umn.edu
612-626-9344

Study Officials

  • Timothy Schacker, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

July 1, 2020

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

October 7, 2025

Results First Posted

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)UG(1)