Trial Outcomes & Findings for The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination (NCT NCT04269265)

Last Updated: 2025-10-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

43 participants

Primary outcome timeframe

18 months

Results posted on

2025-10-07

Participant milestones
Measure	All Participants In this single-arm study, all participants will receive the intervention Yellow Fever Vaccine: YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Overall Study STARTED	43
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	All Participants In this single-arm study, all participants will receive the intervention Yellow Fever Vaccine: YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Overenrolled (sample size reached)	4

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

Baseline characteristics by cohort
Measure	All Participants n=37 Participants In this single-arm study, all participants will receive the intervention Yellow Fever Vaccine: YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Age, Continuous	36.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: 18 months

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

Outcome measures
Measure	All Participants n=37 Participants In this single-arm study, all participants will receive the intervention Yellow Fever Vaccine: YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Peak Neutralizing Antibody Titer	1.37 Log YF antibody titer Interval 1.06 to 1.69

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	All Participants n=37 participants at risk In this single-arm study, all participants will receive the intervention Yellow Fever Vaccine: YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
Nervous system disorders Pain at Incision Site	21.6% 8/37 • Number of events 8 • Through study completion (up to 18 months).
Infections and infestations Infection at Incision Site	18.9% 7/37 • Number of events 8 • Through study completion (up to 18 months).
Infections and infestations Upper Respiratory Tract Infection	10.8% 4/37 • Number of events 5 • Through study completion (up to 18 months).
Blood and lymphatic system disorders Bruising at Incision Site	8.1% 3/37 • Number of events 3 • Through study completion (up to 18 months).
Blood and lymphatic system disorders Bruising at Venipuncture Site	5.4% 2/37 • Number of events 3 • Through study completion (up to 18 months).

University of Minnesota

Phone: 612-626-9344