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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Change in Characterization of Cytomegalovirus (CMV)
Change in Characterization of Epstein-Barr Virus (EBV)
Change in Characterization of YFV
+3 moreSide effects data
From 2012 Phase 3 trial • 552 Patients • NCT014663874%
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
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
1,638 Previous Clinical Trials
2,560,282 Total Patients Enrolled
3 Trials studying Yellow Fever
388 Patients Enrolled for Yellow Fever
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,219 Total Patients Enrolled
8 Trials studying Yellow Fever
875 Patients Enrolled for Yellow Fever
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,069 Total Patients Enrolled
1 Trials studying Yellow Fever
303 Patients Enrolled for Yellow Fever
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study and agree to participate.I agree not to take live vaccines around the time of my trial participation.I have not received blood products or immune globulin within the last 42 days.I am not pregnant, nursing, or planning to become pregnant during the study.I have a condition that weakens my immune system, but not skin cancer or cured non-lymphatic tumors.I have a chronic condition like diabetes or heart disease, or I've used immunosuppressive meds recently.I had COVID-19 recently but am now symptom-free.I have a history of thymus gland issues or autoimmune disorders.I am using birth control and can provide a negative pregnancy test, or I am not able to become pregnant due to surgery or menopause.I am between 18 and 45 years old.I do not have an active Hepatitis B or C infection.I have a history of HIV infection.
Research Study Groups:
This trial has the following groups:- Group 1: HLA-A202-: Yellow Fever Vaccine and Post-vaccination Blood Draws
- Group 2: HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and Fine Needle Aspirate
- Group 3: HLA-A202+: Yellow Fever Vaccine, Post-vaccination Blood Draws and Leukapheresis
- Group 4: HLA-A202+: Yellow Fever Vaccine and Post-vaccination Blood Draws
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participants in this research project?
"At present, this study is not currently accepting participants. Originally posted on May 1st 2008 and updated October 19th 2021, it has since been superseded by other medical trials. Those exploring alternate options should note that there are presently 110 studies recruiting for yellow fever and 7 clinical trials actively seeking patients to test the treatment in question."
Answered by AI
Is the eligibility criteria for this research only those over 18 years of age?
"This clinical trial requires its participants to fall in the 18 to 70 year old age bracket. 30 trials are designed for patients younger than 18, while those over 65 can choose from 76 distinct studies."
Answered by AI
Have any other clinical trials previously investigated this particular therapeutic approach?
"Presently, 7 studies are running regarding this form of treatment. None of these active trials have reached Phase 3 status yet. All the investigations for this drug originate from Madrid, Comunidad De and there are 59 total trial sites worldwide."
Answered by AI
What characteristics make a person an eligible participant for this research?
"To be considered for this medical trial, applicants must have contracted yellow fever and fit within the age range of 18 to 70 years old. The total number of participants required is 200 people."
Answered by AI
How many persons are receiving admission to this experiment?
"This research endeavour is no longer recruiting participants, as the last edit was performed in October 2021. Alternatives for interested persons are available; 110 studies on yellow fever and 7 trials involving this particular treatment are actively searching for enrollees."
Answered by AI
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