Cytomegalovirus Infections, Influenza
Conditions
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.
Interventions
BIOLOGICALFluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Related Adverse Events | Day 0 to Day 28 |
Other
| Measure | Time frame |
|---|---|
| To Compare the T- and B-cell Response to Licensed IM 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 | Day 0 to Day 28 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CMV Negative Group Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly | 33 |
| CMV Positive Group Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly | 37 |
| Recent CMV Converters Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly | 8 |
| Total | 78 |
Baseline characteristics
| Characteristic | CMV Negative Group | CMV Positive Group | Recent CMV Converters | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 21 Participants | 7 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 16 Participants | 1 Participants | 29 Participants |
| Age, Continuous | 66.96 years STANDARD_DEVIATION 4.52 | 67.46 years STANDARD_DEVIATION 5.26 | 66.75 years STANDARD_DEVIATION 3.53 | 67.21 years STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 36 Participants | 8 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 31 Participants | 36 Participants | 8 Participants | 75 Participants |
| Region of Enrollment United States | 33 Participants | 37 Participants | 8 Participants | 78 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 7 Participants | 37 Participants |
| Sex: Female, Male Male | 23 Participants | 17 Participants | 1 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 33 | 0 / 37 | 0 / 8 |
| serious Total, serious adverse events | 0 / 33 | 0 / 37 | 0 / 8 |
Outcome results
Primary
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CMV Negative Group | Number of Participants From Each Arm Who Received Influenza Vaccine | 33 Participants |
| CMV Positive Group | Number of Participants From Each Arm Who Received Influenza Vaccine | 37 Participants |
| Recent CMV Converters | Number of Participants From Each Arm Who Received Influenza Vaccine | 8 Participants |
Secondary
Number of Participants With Related Adverse Events
Time frame: Day 0 to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CMV Negative Group | Number of Participants With Related Adverse Events | 0 Participants |
| CMV Positive Group | Number of Participants With Related Adverse Events | 0 Participants |
| Recent CMV Converters | Number of Participants With Related Adverse Events | 0 Participants |
Other Pre-specified
To Compare the T- and B-cell Response to Licensed IM 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
Time frame: Day 0 to Day 28