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The Influence of Chronic CMV Infection on Influenza Vaccine Responses (SLVP025)

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ClinicalTrials.gov Identifier: NCT02134184
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : December 26, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cornelia L. Dekker, Stanford University

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Influenza Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Influence of Chronic Cytomegalovirus Infection on Influenza Vaccine Responses
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: CMV negative group
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
Other Name: Trivalent inactivated influenza vaccine (TIV)

Experimental: CMV positive group
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
Other Name: Trivalent inactivated influenza vaccine (TIV)

Experimental: Recent CMV Converters
Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50
Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50
This vaccine is given intramuscularly
Other Name: Trivalent inactivated influenza vaccine (TIV)




Primary Outcome Measures :
  1. Number of Participants From Each Arm Who Received Influenza Vaccine [ Time Frame: Day 0 to Day 28 ]

Secondary Outcome Measures :
  1. Number of Participants With Related Adverse Events [ Time Frame: Day 0 to Day 28 ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134184


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Cornelia L Dekker, MD Stanford University
Principal Investigator: Jorg J Goronzy, MD, PhD Stanford University
Additional Information:
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Responsible Party: Cornelia L. Dekker, Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT02134184    
Other Study ID Numbers: SU-25199
1U19AI090019-01 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2014    Key Record Dates
Results First Posted: December 26, 2016
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Influenza, Human
Cytomegalovirus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Herpesviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs