The Influence of Chronic Cytomegalovirus Infection on Influenza Vaccine Responses
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Number of Participants From Each Arm Who Received Influenza Vaccine
Overview
Brief Summary
In this study we are trying to understand whether previous infection with a particular virus, namely cytomegalovirus (CMV), influences the ability of the immune system to respond to new infections or vaccinations with age.
Detailed Description
The investigators want to compare the T- and B-cell response to conventional intramuscular trivalent influenza vaccine (TIV) in elderly individuals dependent on the presence and duration of CMV infection by analyses of vaccine-induced plasmablasts, antibodies and antigen-specific T cells. Healthy volunteers, > 60 years of age, will be identified by the Stanford Blood Center based on their history of positive or negative CMV serologies. Baseline blood samples will be drawn from all study participants prior to immunization. All participants will receive a single dose of 2012-2013 licensed TIV. Volunteers will complete 3 study visits at Day 0, Day 7 and Day 28.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Otherwise healthy, ambulatory adult 60 years of age or above.
- •Self-identified by a participant after notification by Stanford Blood Center (SBC) of their group assignment based review of SBC CMV data:
- •CMV-negative: Donor has donated at least twice during the last 3 years AND donor's most recent two donations tested CMV antibody negative.
- •CMV positive longstanding infection: Donor has donated at least once within the "recent" timeframe (past three years) AND donor's most recent donation tested CMV antibody positive AND donor had at least one donation prior to 2000 that tested CMV antibody positive.
- •Recent CMV converters: Donor has donated at least once within the "recent" timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past.
- •Willing to complete the informed consent process.
- •Availability for follow-up for the planned duration of the study at least 28 days after immunization.
- •Acceptable medical history by review of inclusion/exclusion criteria and vital signs.
Exclusion Criteria
- •Prior off-study vaccination with the current 2012-2013 seasonal influenza vaccine
- •Allergy to egg or egg products, or to vaccine components or thimerosal (TIV multidose vials only)
- •Life-threatening reactions to previous influenza vaccinations.
- •Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- •Weight less than 110 lbs
- •History of immunodeficiency (including HIV infection)
- •Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- •Blood pressure \>150 systolic or \>95 diastolic at first study visit
- •Hospitalization in the past year for congestive heart failure or emphysema.
- •History of chronic Hepatitis B or C.
Outcomes
Primary Outcomes
Number of Participants From Each Arm Who Received Influenza Vaccine
Time Frame: Day 0 to Day 28
Secondary Outcomes
- Number of Participants With Related Adverse Events(Day 0 to Day 28)
Investigators
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
Stanford University