Yellow FeverNCT00616356
Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults
An observational study of Yellow Fever, run by Rockefeller University at 1 site in United States.
Trial summary
The investigators at Rockefeller University are doing this research to study how the immune system responds to viruses and other infectious agents by using the yellow fever 17D vaccine as a model. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Rockefeller University Personnel
Who may be able to join
- Able to give informed consent.
- Age 18-45 years.
- Agrees not to take any vaccines within 30 days before or 30 days after YFV vaccination.
Who cannot join
- Previously vaccinated with yellow fever vaccine.
- A history of a medical condition resulting in impaired immunity.
- Use of immunosuppressive medications.
- Thymus gland dysfunction.
- Recipient of a blood product or immune globulin product within 42 days of the screening visit or 30 days after the YFV vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators at Rockefeller University are doing this research to study how the immune system responds to viruses and other infectious agents by using the yellow fever 17D vaccine as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s. By studying how the human immune system responds to the YFV vaccine we hope to learn more about the normal functioning of the immune system so that it might be possible to design new, more effective types of vaccines to prevent important infectious diseases.
The reason for doing this research is:
Read more
Currently there is very little information about which factors determine the effectiveness of the initial (primary) immune response to a foreign substance (antigen), such as a virus, that person may be exposed to. There is also very little known about what determines how effectively and for how long a person's immune system can react to the same antigen to prevent another infection. Studies in animals have given us important information about how the immune systems of other animals behave upon initial or repeated exposure to antigens,but these topics have not been studied in detail in humans.
The following hypotheses will be tested:
- The magnitude of the initial expansion of T lymphocytes (the "clonal burst") specific for the infecting virus determines the level at which memory T cell responses are generated against the specific viral antigen and the duration of the memory T cell response generated in the body.
- The majority of CD8 T cells generated after immunization are yellow fever specific and not "bystander activation" of non-specific cells.
- Conditions
- Yellow Fever
- Keywords
- Yellow Fever
- Medical subject headings
- Yellow Fever
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Charles Rice, Rockefeller University
- Investigators
- Charles M Rice, PhD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616356
- Sponsor's protocol ID
- RUH IRB # CRI-0618
- Status last verified
- Nov 2011
- First submitted
- 23 Jan 2008
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults
- ClinicalTrials.gov ID
- NCT00616356
- Acronym / sponsor ID
- RUH IRB # CRI-0618
- Conditions
- Yellow Fever
- Keywords
- Yellow Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Feb 2008 (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 investigators at Rockefeller University are doing this research to study how the immune system responds to viruses and other infectious agents by using the yellow fever 17D vaccine as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s. By studying how the human immune system responds to the YFV vaccine we hope to learn more about the normal functioning of the immune system so that it might be possible to design new, more effective types of vaccines to prevent important infectious diseases.
The reason for doing this research is:
Currently there is very little information about which factors determine the effectiveness of the initial (primary) immune response to a foreign substance (antigen), such as a virus, that person may be exposed to. There is also very little known about what determines how effectively and for how long a person's immune system can react to the same antigen to prevent another infection. Studies in animals have given us important information about how the immune systems of other animals behave upon initial or repeated exposure to antigens,but these topics have not been studied in detail in humans.
The following hypotheses will be tested:
- The magnitude of the initial expansion of T lymphocytes (the "clonal burst") specific for the infecting virus determines the level at which memory T cell responses are generated against the specific viral antigen and the duration of the memory T cell response generated in the body.
- The majority of CD8 T cells generated after immunization are yellow fever specific and not "bystander activation" of non-specific cells.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Rockefeller University Personnel
Key inclusion criteria (3 listed)
- Able to give informed consent.
- Age 18-45 years.
- Agrees not to take any vaccines within 30 days before or 30 days after YFV vaccination.
Key exclusion criteria (5 listed)
- Previously vaccinated with yellow fever vaccine.
- A history of a medical condition resulting in impaired immunity.
- Use of immunosuppressive medications.
- Thymus gland dysfunction.
- Recipient of a blood product or immune globulin product within 42 days of the screening visit or 30 days after the YFV vaccination.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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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. This study is not recruiting at the moment.
Charles M Rice, PhD principal investigator
Rockefeller 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, run by Rockefeller 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 5 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: finished, as of the sponsor's last update on 8 Nov 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 8 Nov 2011.