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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AI090019-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMV negative group | Experimental | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
|
| CMV positive group | Experimental | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
|
| Recent CMV Converters | Experimental | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® 2012-2013 Formula NDC No 498281-012-50 | Biological | This vaccine is given intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | Day 0 to Day 28 |
| Measure | Description | 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 |
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L Dekker, MD | Stanford University | Principal Investigator |
| Jorg J Goronzy, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.
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| ID | Title | Description |
|---|---|---|
| FG000 | CMV Negative Group | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly |
| FG001 | CMV Positive Group | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly |
| FG002 | Recent CMV Converters | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly Recent CMV Conversion is defined as: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CMV Negative Group | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly |
| BG001 | CMV Positive Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants From Each Arm Who Received Influenza Vaccine | Posted | Count of Participants | Participants | Day 0 to Day 28 |
|
Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CMV Negative Group | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Community Acquired Pneumonia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cornelia Dekker | Stanford University School of Medicine, Dept. of Pediatrics | 650-724-4437 | cdekker@stanford.edu |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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|
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly
| BG002 | Recent CMV Converters | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
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| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to Day 28 |
|
|
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| 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 | Not Posted | Day 0 to Day 28 | Participants |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | CMV Positive Group | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly | 0 | 37 | 0 | 37 |
| EG002 | Recent CMV Converters | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 This vaccine is given intramuscularly | 0 | 8 | 0 | 8 |
|
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| D012141 |
| Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |