Characterization of Human Memory Immune Responses to Prio... | NCT01244802

Studies
Characterization of Human Memory Immune Responses to Prior Yellow Fever Vaccination

NCT01244802

Sponsor

Emory University

Status

Enrolling by invitation

Last Update Posted

Nov 4, 2024Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Yellow Fever Vaccine

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U19AI057266	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Oct 2029Estimated

Completion Date

Oct 2029Estimated

First Submitted Date

Nov 18, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2024

Last Update Posted Date

Nov 4, 2024Actual

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Immune responses will be measured from at least 30 days after yellow fever vaccination.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy adults between the ages of 18 to 45 years or 55 or above who previously received the yellow fever vaccine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rafi Ahmed, PhD	Emory University	Study Chair
Srilatha Edupuganti, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hope clinic of Emory Vaccine Center		Decatur	Georgia	30030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided