Yellow Fever VaccineNCT01244802
Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination
An observational study of Yellow Fever Vaccine, run by Emory University at 1 site in United States.
Trial summary
The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever Vaccine
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine
Who may be able to join
- Able to understand and give informed consent
- Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination
- Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.
Who cannot join
- Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)
- History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)
- Required use of immunosuppressive medications
- Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form
- Recipient of a blood product or immune globulin product within 42 days of study visit
- Reporting pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Hope clinic of Emory Vaccine Center
Decatur, Georgia, 30030
About this study
The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.
Read the detailed description
The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.
The specific aims of the study are to:
- Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination
- Determine neutralizing antibody titer after yellow fever vaccination
- Conditions
- Yellow Fever Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 18 to 45 years of age | Between the ages of 18 and 45 at the time of yellow fever vaccination | |
| Group 2: 55 years of age and above | Aged 55 or greater at the time of yellow fever vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination
This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.
Measured: Immune responses will be measured from at least 30 days after yellow fever vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow Fever VaccineStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sri Edupuganti, Emory University
- Investigators
- Rafi Ahmed, PhD, Study chair, Emory UniversitySrilatha Edupuganti, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244802
- Sponsor's protocol ID
- IRB00002834
- Other IDs
- U19AI057266
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2010
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination
- ClinicalTrials.gov ID
- NCT01244802
- Acronym / sponsor ID
- IRB00002834
- Conditions
- Yellow Fever Vaccine
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2010
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to study immune memory generated against the yellow fever (YFV) vaccine in participants who have previously received the vaccine. Volunteers will not receive vaccine shots; only immune responses to previous yellow fever vaccination will be studied. The study involves one or multiple blood draws.
Detailed description
The goal of this study is to characterize immune memory in humans who have previously received yellow fever vaccine. The project is designed to study the magnitude and persistence of both humoral, and cell-mediated immune memory generated post-vaccination. Since aging has an effect on the immune system (eg. decreased thymic output, replacement of hematopoietic cells in the bone marrow with adipocytes), the researchers will analyze the young adults (aged 18-45 years) and the older vaccinees (55 years or older) in separate groups.
The specific aims of the study are to:
- Determine the phenotypic and functional characterization of memory T cell responses to yellow fever vaccination
- Determine neutralizing antibody titer after yellow fever vaccination
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 18 to 45 years of age | – | –Between the ages of 18 and 45 at the time of yellow fever vaccination |
| Group 2: 55 years of age and above | – | –Aged 55 or greater at the time of yellow fever vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine
Key inclusion criteria (3 listed)
- Able to understand and give informed consent
- Age 18-45 years (Group 1) or 55 years and above (Group 2) at the time of yellow fever vaccination
- Documentation (international certificate of vaccination (yellow card) or medical record) indicating receipt of yellow fever vaccine.
Key exclusion criteria (6 listed)
- Recipient of any vaccines within 30 days before the study visit (not applicable to older adults)
- History of a progressive and severe chronic medical condition resulting in impaired immunity (such as diabetes, kidney or liver dysfunction)
- Required use of immunosuppressive medications
- Reporting HIV, Hepatitis B (surface antigen positive) or Hepatitis C infections (antibody positive) on the medical/health history form
- Recipient of a blood product or immune globulin product within 42 days of study visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination
Time frame: Immune responses will be measured from at least 30 days after yellow fever vaccination.
This is an exploratory analysis of variation in immune response with time since last yellow fever virus vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafi Ahmed, PhD study chair
Emory University
Srilatha Edupuganti, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Yellow Fever Vaccine, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the phenotypic and functional characterization of memory T cell responses to YF vaccination (time frame: Immune responses will be measured from at least 30 days after yellow fever vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.