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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
124
Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Correlative studies
High Dose Trivalent Influenza Vaccine given intramuscularly
University of Alabama
Birmingham, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
Time frame: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza B antigens.
Time frame: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Solicited Local Injection Site Adverse Events
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."
Time frame: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Solicited Systemic Adverse Events
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol. Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.
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Time frame: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Percentage of Individuals in Each Group That Test Positive for Influenza by PCR
The percentage of breakthrough flu in vaccinated participants, separated by treatment group.
Time frame: Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.