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


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Primary Outcome Measures:

  • HD-TIV compared with SD-QIV (Influenza A) – immunogenicity [ Time Frame: Up to 42 days ]

    We will measure ≥4-fold rise in HAI titers, ≥1:40 HAI titer, or higher GMT titers to influenza A antigens

Secondary Outcome Measures:

  • HD-TIV compared with SD-QIV (Influenza B) – immunogenicity [ Time Frame: Up to 42 days ]

    We will measure ≥4-fold rise in HAI titers, ≥1:40 HAI titer, or higher GMT titers to influenza B antigens

  • Solicited local injection site adverse events [ Time Frame: Up to 10 days following each vaccination ]

    We will measure solicited adverse event (.e.g. pain/tenderness, redness, and swelling at injection site).

  • Solicited systemic adverse events [ Time Frame: Up to 10 days following each vaccination. ]

    We will measure solicited adverse event ((e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting).

  • 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

  • Number of influenza-like illness in each group during the influenza season. [ Time Frame: Up to 10 days following each vaccination ]

    Will be compared between groups

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 followed up at 1-3 and 8-10 days after each vaccination visit.