The Influence of Chronic CMV Infection on Influenza Vaccine Responses

NCT02134184 | Completed Phase 4 Results

• 2 other identifiers: SU-251991U19AI090019-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections; Influenza

Outcome Measures

Primary Outcomes (1)

• Number of Participants From Each Arm Who Received Influenza Vaccine

  Day 0 to Day 28

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to Day 28

Other Outcomes (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

  Day 0 to Day 28

Study Arms (3)

CMV negative group

EXPERIMENTAL

Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50

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

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

Biological: Fluzone® 2012-2013 Formula NDC No 498281-012-50

Interventions

Fluzone® 2012-2013 Formula NDC No 498281-012-50 BIOLOGICAL

This vaccine is given intramuscularly

Also known as: Trivalent inactivated influenza vaccine (TIV)

CMV negative group; CMV positive group; Recent CMV Converters

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Cornelia Dekker
• Organization: Stanford University School of Medicine, Dept. of Pediatrics

cdekker@stanford.edu

650-724-4437

Study Officials

• Cornelia L Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jorg J Goronzy, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 19, 2023
• Results First Posted: December 26, 2016

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)