Cytomegalovirus InfectionsPhase 4SLVP025NCT02134184
The Influence of Chronic CMV Infection on Influenza Vaccine Responses
A Phase 4 study testing Fluzone® 2012-2013 Formula NDC No 498281-012-50 in people with Cytomegalovirus Infections and Influenza, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cytomegalovirus Infections, Influenza
- What is being tested?
- Fluzone® 2012-2013 Formula NDC No 498281-012-50
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups)
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg aspirin per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Receipt of blood or blood products within the past 6 months or planned receipt of blood products prior to completion of study visits.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Live, attenuated vaccine within 60 days of vaccination or planned non-study vaccination prior to completion of Visit 03 (~Day 28 after the study vaccination)
- Need an allergy immunization (that cannot be postponed) during the study period V01 to V03 (~Day 28)
- History of Guillain-Barré Syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use of investigational agents prior to completion of study visits
- Donation of the equivalent of a unit of whole blood within 6 weeks or a unit of platelets within 2 weeks prior to enrollment or planned blood donation prior to completion of study visits.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Influence of Chronic Cytomegalovirus Infection on Influenza Vaccine Responses
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.
Read the 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.
- Conditions
- Cytomegalovirus Infections, Influenza
- Being tested
- Fluzone® 2012-2013 Formula NDC No 498281-012-50
- Medical subject headings
- Cytomegalovirus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone® 2012-2013 Formula NDC No 498281-012-50Biological
Also called Trivalent inactivated influenza vaccine (TIV)
This vaccine is given intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| CMV negative group | Experimental | Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants From Each Arm Who Received Influenza Vaccine
Measured: Day 0 to Day 28
Secondary outcomes (1)
Number of Participants With Related Adverse Events
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Grant, Stanford University
- Investigators
- Cornelia L Dekker, MD, Principal investigator, Stanford UniversityJorg J Goronzy, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134184
- Sponsor's protocol ID
- SU-25199
- Other IDs
- 1U19AI090019-01
- Acronym
- SLVP025
- Status last verified
- Apr 2023
- First submitted
- 7 May 2014
- Last updated
- 19 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Chronic Cytomegalovirus Infection on Influenza Vaccine Responses
- ClinicalTrials.gov ID
- NCT02134184
- Acronym / sponsor ID
- SLVP025 / SU-25199
- Conditions
- Cytomegalovirus Infections, Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CMV negative group | Experimental | Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
| CMV positive group | Experimental | Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
| Recent CMV Converters | Experimental | Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluzone® 2012-2013 Formula NDC No 498281-012-50Also: Trivalent inactivated influenza vaccine (TIV)This vaccine is given intramuscularly | Biological | CMV negative group, CMV positive group, Recent CMV Converters |
Primary outcome
Number of Participants From Each Arm Who Received Influenza Vaccine
Time frame: Day 0 to Day 28
1 secondary outcome
Number of Participants With Related Adverse Events
Time frame: Day 0 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Cytomegalovirus Infections
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The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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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.
Cornelia L Dekker, MD principal investigator
Stanford University
Jorg J Goronzy, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluzone® 2012-2013 Formula NDC No 498281-012-50 in people with Cytomegalovirus Infections and Influenza, run by Stanford 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 8 inclusion and 24 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 19 Apr 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Participants From Each Arm Who Received Influenza Vaccine (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.
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 19 Apr 2023.