High-Dose Trivalent Influenza Vaccine or Standard-Dose Quadrivalent Inactivated Influenza Vaccine in Treating 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.
Inclusion Criteria
- Allogeneic HSCT recipients who are 3-23 months post-transplant
- Available for duration of study
- Patients with stable graft versus host disease (GVHD) for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable)
- Can be reached by telephone and/or electronic communication
- 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, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-23 months post-transplant
- FOR REPEATERS: Available for duration of study
- FOR REPEATERS: Can be reached by telephone and/or electronic communication
- FOR REPEATERS: Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable)
- FOR REPEATERS: 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, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-23 months post-transplant.
Exclusion Criteria
- History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein
- History of Guillain-Barre syndrome
- Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted)
- History of receiving current seasonal influenza vaccine post-transplant
- Pregnant female
- History of proven influenza disease after September 1, 2018 prior to enrollment
- Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients
- History of known active infection with human immunodeficiency virus (HIV)
- History of cirrhosis
- 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)/subcutaneous immunoglobulin therapy (SCIG) < 28 days prior to vaccination
- FOR REPEATERS: Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted)
- FOR REPEATERS: History of receiving current seasonal influenza vaccine post-transplant
- FOR REPEATERS: Pregnant female
- FOR REPEATERS: History of proven influenza disease after September 1, 2019 prior to enrollment
- FOR REPEATERS: History of known active infection with HIV
- FOR REPEATERS: History of cirrhosis
- FOR REPEATERS: Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
- FOR REPEATERS: Receipt of IVIG/SCIG < 28 days prior to calendar day of vaccination
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03179761.
PRIMARY OBJECTIVE:
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 higher geometric mean titer (GMT) titers 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 (MN) responses.
VI. To compare the persistent HAI and 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 SD-QIV.
VIII. To assess HAI and MN response in patients (e.g. repeaters) undergoing two-consecutive years revaccination using the same antigen dose.
IX. To correlate HAI responses to neuraminidase inhibition titers (NAI).
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 followed up at 1-3 and 8-10 days after each vaccination visit.
Trial PhasePhase II
Trial Typeprevention
Lead OrganizationVanderbilt University/Ingram Cancer Center
Principal InvestigatorNatasha Halasa
- Primary IDVICC BMT 1733
- Secondary IDsNCI-2017-00466
- ClinicalTrials.gov IDNCT03179761