High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
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.
- Hematopoietic Cell Transplantation
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
Group I (HD-TIV)
|Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.||
|Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.||
- NCT ID
- Vanderbilt-Ingram Cancer Center
Study ContactClinical Trials Reporting Program
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.
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.