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Virus Therapy

Yellow Fever Vaccine Immune Response Study

Phase 4
Recruiting
Led By Sri Edupuganti, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-45 years
Be between 18 and 65 years old
Must not have
Pregnant women and nursing mothers or women who are planning to become pregnant for the duration of the study
Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (day of vaccination), day 3, day 7, day 14, day 21, day 28, day 90, day 180, day 360
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is looking at how well the yellow fever vaccine works in people of different ages, by testing their blood before and after they receive the vaccine.

Who is the study for?
This trial is for healthy adults aged 18-45 who haven't lived in yellow fever areas or had certain viral infections/vaccinations. Participants must not be pregnant, plan to become pregnant, or have immune system issues. They should avoid other vaccines and some medications before and after getting the yellow fever vaccine.
What is being tested?
The study tests how the human body responds to the YFV-17D (YF-VAX) yellow fever vaccine. It's a live attenuated virus used as a model for studying immune reactions to viruses over one month to one year.
What are the potential side effects?
Possible side effects of the YFV-17D vaccine may include mild pain at injection site, headache, muscle pain, low-grade fever, fatigue or allergic reactions in those sensitive to eggs, chicken proteins or gelatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I have a history of thymus gland issues or autoimmune disorders.
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I do not have an active Hepatitis B or C infection.
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I have a history of HIV infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (day of vaccination), day 3, day 7, day 14, day 21, day 28, day 90, day 180, day 360
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 (day of vaccination), day 3, day 7, day 14, day 21, day 28, day 90, day 180, day 360 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Magnitude of YFV-specific Antibody Secreting Cells
Change in Magnitude of YFV-specific Memory B Cells
Change in Magnitude of Yellow Fever Virus (YFV) specific T Cell Responses
+7 more
Secondary study objectives
Change in Characterization of Cytomegalovirus (CMV)
Change in Characterization of Epstein-Barr Virus (EBV)
Change in Characterization of YFV
+3 more

Side effects data

From 2012 Phase 3 trial • 552 Patients • NCT01466387
4%
Headache
2%
Injection site pain
2%
Influenza like illness
1%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MenACWY-CRM197 (Combined)
JE+Rabies+MenACWY-CRM197
TF+YF+MenACWY-CRM197
JE+Rabies
Rabies
TF+YF

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Experimental Treatment
Group I: HLA-A202-: Yellow Fever Vaccine and Post-vaccination Blood DrawsExperimental Treatment1 Intervention
HLA-A202- participants receiving Yellow Fever Vaccine plus post-vaccination blood draws.
Group II: HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and LeukapheresisExperimental Treatment1 Intervention
HLA-A202+ participants receiving Yellow Fever Vaccine plus post-vaccination blood draws and leukapheresis.
Group III: HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and Fine Needle AspirateExperimental Treatment1 Intervention
HLA-A202+ participants receiving Yellow Fever Vaccine plus post-vaccination blood draws and fine needle aspirate.
Group IV: HLA-A202+: Yellow Fever Vaccine and Post-vaccination Blood DrawsExperimental Treatment1 Intervention
HLA-A202+ participants receiving Yellow Fever Vaccine plus post-vaccination blood draws.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yellow Fever Vaccine
2016
Completed Phase 4
~1490

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,708 Previous Clinical Trials
2,607,248 Total Patients Enrolled
3 Trials studying Yellow Fever
388 Patients Enrolled for Yellow Fever
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,335 Previous Clinical Trials
5,382,554 Total Patients Enrolled
8 Trials studying Yellow Fever
600 Patients Enrolled for Yellow Fever
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,171,868 Total Patients Enrolled
1 Trials studying Yellow Fever
27 Patients Enrolled for Yellow Fever
Rafi Ahmed, PhDStudy ChairEmory University
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Yellow Fever
300 Patients Enrolled for Yellow Fever
Sri Edupuganti, MD, MPHPrincipal InvestigatorEmory University

Media Library

Yellow Fever Virus Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00694655 — Phase 4
Yellow Fever Research Study Groups: HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and Fine Needle Aspirate, HLA-A202-: Yellow Fever Vaccine and Post-vaccination Blood Draws, HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and Leukapheresis, HLA-A202+: Yellow Fever Vaccine and Post-vaccination Blood Draws
Yellow Fever Clinical Trial 2023: Yellow Fever Virus Vaccine Highlights & Side Effects. Trial Name: NCT00694655 — Phase 4
Yellow Fever Virus Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00694655 — Phase 4
~14 spots leftby Dec 2025
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