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High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03179761
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:
This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.

Condition or disease Intervention/treatment Phase
Hematopoietic Cell Transplantation Biological: Quadrivalent Inactivated Influenza Vaccine Other: Laboratory Biomarker Analysis Biological: Trivalent Influenza Vaccine Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination inhibition assay (HAI) titer, >= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.

SECONDARY OBJECTIVES:

I. To determine whether HD-TIV compared with SD-QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in adult HSCT recipients.

II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/tenderness, redness, and swelling at injection site) with HD-TIV compared to SD-QIV in adult HSCT recipients.

III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to SD-QIV in adult HSCT recipients.

IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in adult HSCT recipients receiving either HD-TIV or SD-QIV.

V. To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.

VII. To compare influenza detection by polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.

GROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.

After completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.


Study Type : Interventional
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group I (HD-TIV)
Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.
Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Trivalent Influenza Vaccine
Given intramuscularly

Active Comparator: Group 1(SD-QIV)
Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.
Biological: Quadrivalent Inactivated Influenza Vaccine
Given intramuscularly

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. HD-TIV compared with SD-QIV (Influenza A) - immunogenicity [ Time Frame: Up to 42 days ]
    Investigators will measure ≥4-fold rise in HAI titers, ≥1:40 HAI titer, or higher GMT titers to influenza A antigens


Secondary Outcome Measures :
  1. HD-TIV compared with SD-QIV (Influenza B) - immunogenicity [ Time Frame: Up to 42 days ]
    Investigators will measure ≥4-fold rise in HAI titers, ≥1:40 HAI titer, or higher GMT titers to influenza B antigens

  2. Solicited local injection site adverse events [ Time Frame: Up to 10 days following each vaccination ]
    Investigators will measure solicited adverse event (.e.g. pain/tenderness, redness, and swelling at injection site).

  3. Solicited systemic adverse events [ Time Frame: Up to 10 days following each vaccination. ]
    Investigators will measure solicited adverse event ((e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting).

  4. Percentage of individuals in each group that test positive for influenza by PCR [ Time Frame: Up to 10 days following each vaccination ]
    Testing of individuals nose swabs from influenza will be done, and compared to each group

  5. Number of influenza-like illness in each group during the influenza season. [ Time Frame: Up to 10 days following each vaccination ]
    Investigators will compare the number of illnesses between groups


Other Outcome Measures:
  1. B Cell (B Lymphocytes; B Cell; B-Cell; B-Lymphocyte; B Lymphocyte; Bursa-Dependent Lymphocytes; B-Cells; Bursa-Equivalent Lymphocyte; B-Lymphocytes) [ Time Frame: Up to 180 days ]
    The total number of B cells will be measured prior to each vaccination and compared to each group.

  2. T Cell (T Lymphocyte; T-Cell; Thymus-Dependent Lymphocytes; Thymus Derived Lymphocyte; T-Lymphocyte) [ Time Frame: Up to 180 days ]
    The total number of T cells will be measured prior to each vaccination and compared to each group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Allogeneic HSCT recipients who are 3-23 months post-transplant
  • Available for duration of study
  • If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD), then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible
  • Can be reached by telephone or email
  • Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization; for subjects < 12 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 14 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization; for subjects 12-23 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 90 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization

Exclusion Criteria:

  • History of hypersensitivity to previous influenza vaccination or severe or moderate hypersensitivity to eggs/egg protein
  • History of Guillain-Barre syndrome
  • Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms are permitted)
  • History of receiving 2017-2018 influenza vaccine
  • Pregnant female
  • History of proven influenza disease after September 1, 2017
  • Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients
  • History of known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • History of known latex hypersensitivity
  • Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
  • Receipt of intravenous immunoglobulin therapy (IVIG) < 27 days prior to vaccination
  • CD34 selection or total cell depletion outside haploidentical transplants

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): NCT03179761


Contacts
Contact: Clinical Trials Reporting Program 800-811-8480 cip@vanderbilt.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Edgar Overton    205-934-5191      
Principal Investigator: Edgar Overton, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael Ison, MD    312-695-4186      
Principal Investigator: Michael Ison, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Reporting Program    800-811-8480      
Principal Investigator: Natasha Halasa, MD         
United States, Washington
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Steven Pegram, MD    206-667-7538      
Principal Investigator: Steven Pegram, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center

Responsible Party: Natasha Halasa, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03179761     History of Changes
Other Study ID Numbers: VICC BMT 1733
NCI-2017-00466 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs