Human Immune Responses to The Yellow Fever Virus Vaccine
This study is currently recruiting participants.
Verified March 2012 by Emory University
Sponsor:
Emory University
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
ClinicalTrials.gov Identifier:
NCT00694655
First received: May 19, 2008
Last updated: December 19, 2012
Last verified: March 2012
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Purpose
The objective of this study is to study immune memory generated against the yellow fever vaccine (YFV) in participants who recently received the YFV vaccine. Volunteers who are planning to travel to yellow fever endemic areas will be recruited into this study. Volunteers will receive the yellow fever vaccine at the Hope Clinic of Emory University or at their private health care provider's office. Blood tests will be drawn before the vaccination and at upto 8 visits following vaccination. A volunteers's study participation may will last as short as 1 month or as long as one year depending on the immune responses.
We plan to compare the immune responses in younger people (18 to 45 years) to that of older people (55 or above).
| Condition | Intervention |
|---|---|
|
Yellow Fever |
Biological: Yellow fever vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Human Immune Responses to Yellow Fever Vaccination |
Resource links provided by NLM:
Further study details as provided by Emory University:
Primary Outcome Measures:
- 1. Isolation and characterization of yellow fever vaccine (YFV-17D) specific adaptive immune responses: characterize the magnitude and quality of YFV specific T cell responses, antibody secreting cells and memory B cells. [ Time Frame: Upto 12 months after vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the signatures of innate immune responses: cytokines, chemokines, dendritic cells and microarray analyses on peripheral blood mononuclear cells [ Time Frame: Upto 12 months after vaccination ] [ Designated as safety issue: No ]Compare the magnitude and kinetics of T and B cell responses, antibody secreting cells and memory B cells in the younger and the older age group
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
vaccine
There are no arms for this study. All participants will receive the YFV vaccine if they meet the screening criteria.
|
Biological: Yellow fever vaccine
YFV will be given as injection
Other Name: YF-VAX
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Able to understand and give informed consent
- Age 18-45 years or greater than or equal to 55 years
- If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination
- Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.
Exclusion Criteria:
- Travel to or having lived in a country/area which is endemic for yellow fever
- History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection
- Any history of allergy to eggs, chicken or gelatin or to any previous vaccine
- A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
- History of HIV infection, Hepatitis B or Hepatitis C infection
- History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension). Use of systemic immunosuppressive medications (ex, prednisone) for 2 weeks or more in the past 3 months
- History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial
- Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder.
- Recipient of a blood products or immune globulin product within 42 days of the vaccination visit
- Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration
- Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694655
Contacts
| Contact: Shashi Nagar, MA | 404-712-1407 | shashi.nagar@emory.edu |
| Contact: Srilatha Edupuganti | 404-712-1370 | sedupug@emory.edu |
Locations
| United States, Georgia | |
| The Hope Clinic of the Emory Vaccine Center | Recruiting |
| Decatur, Georgia, United States, 30030 | |
| Contact: Eileen Oskinski 404-712-1371 gosinsk@emory.edu | |
| Contact: Vickie Grimes, RN 404-712-1404 vgrimes@emory.edu | |
| Sub-Investigator: Mark J Mulligan, MD | |
| Sub-Investigator: Rafi Ahmed, PhD | |
| Sub-Investigator: Rama Akondy, PhD | |
Sponsors and Collaborators
Emory University
Investigators
| Study Chair: | Rafi Ahmed, PhD | Emory University |
| Principal Investigator: | Sri Edupuganti, MD, MPH | Emory University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sri Edupuganti, MD MPH, Assistant Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00694655 History of Changes |
| Other Study ID Numbers: | YFV/Human Immune Responses |
| Study First Received: | May 19, 2008 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Yellow Fever Vaccine Immunity yellow fever vaccine CD8 T cell responses |
Additional relevant MeSH terms:
|
Fever Yellow Fever Body Temperature Changes Signs and Symptoms Arbovirus Infections |
Virus Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 16, 2013