Human Immune Responses to The Yellow Fever Virus Vaccine
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| ClinicalTrials.gov Identifier: NCT00694655 |
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Recruitment Status :
Active, not recruiting
First Posted : June 10, 2008
Last Update Posted : October 20, 2021
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Sponsor:
Emory University
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sri Edupuganti, MD MPH, Emory University
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Yellow Fever | Biological: Yellow fever vaccine | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Human Immune Responses to Yellow Fever Vaccination |
| Study Start Date : | May 2008 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Yellow Fever Vaccine
| Arm | Intervention/treatment |
|---|---|
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vaccine
There are no arms for this study. All participants will receive the YFV vaccine if they meet the screening criteria.
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Biological: Yellow fever vaccine
YFV will be given as injection
Other Name: YF-VAX |
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 ]Compare the magnitude and quality of YFV-specific immune responses in the younger and older age groups.
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 ]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 groups.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694655
Locations
| United States, Georgia | |
| The Hope Clinic of the Emory Vaccine Center | |
| Decatur, Georgia, United States, 30030 | |
Sponsors and Collaborators
Emory University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
| Study Chair: | Rafi Ahmed, PhD | Emory University | |
| Principal Investigator: | Sri Edupuganti, MD, MPH | Emory University |
Additional Information:
| Responsible Party: | Sri Edupuganti, MD MPH, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00694655 |
| Other Study ID Numbers: |
IRB00009560 YFV/Human Immune Responses ( Other Identifier: Other ) 5U19AI057266 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 10, 2008 Key Record Dates |
| Last Update Posted: | October 20, 2021 |
| Last Verified: | October 2021 |
Keywords provided by Sri Edupuganti, MD MPH, Emory University:
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Yellow Fever Vaccine Immunity yellow fever vaccine CD8 T cell responses |
Additional relevant MeSH terms:
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Yellow Fever Fever Hyperthermia Body Temperature Changes Heat Stress Disorders Wounds and Injuries Arbovirus Infections |
Vector Borne Diseases Infections Virus Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections Hemorrhagic Fevers, Viral |