This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.
The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV. The secondary objectives of this study are to: * Describe the safety and reactogenicity of high-dose and standard-dose TIV. * Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV. * Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Rate of Seroconversion After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Rate of Seroprotection After 1 Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Time frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
The immune response of Fluzone HD to Fluzone was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroprotection was defined as a post-vaccine HAI titer ≥40.
Time frame: 21 to 42 days after second dose
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.
Time frame: From initial vaccine administration through up to 8 months
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone HD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
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Time frame: at least 21 days after each dose of vaccine
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
The rate of seroconversion to the 3 antigens contained in the vaccine was determined by hemagglutination-inhibition test and was compared by disease. The immune response of 1 dose vs. 2 doses of Fluzone SD was determined using the hemagglutination-inhibition (HAI) assay to each of the 3 antigens contained in the vaccine: H1, H3 and B. Seroconversion was defined as a post-vaccine HAI titer ≥40 if baseline was \<10, or a 4-fold rise in HAI titer if the baseline ≥10.
Time frame: at least 21 days after each dose of vaccine
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
The relationship between baseline lymphocyte numbers/function and robustness of the immune response will be described through descriptive analysis of relationships between pre-defined variables.
Time frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine
Number of Local Reactogenicity Events After First Dose
Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
Time frame: First 14 days after vaccination
Number of Local Reactogenicity Events After Second Dose
Number of moderate or greater local reactogenicity events associated with the administration of Fluzone or FluzoneHD. Local reactions were defined as pain, redness, or induration.
Time frame: First 14 days after vaccination
Number of Systemic Reactogenicity Events After First Dose
Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
Time frame: First 14 days after vaccination
Number of Systemic Reactogenicity Events After Second Dose
Number of moderate or greater systemic reactogenicity event associated with the administration of Fluzone or FluzoneHD. Systemic reactions were defined as muscle ache, fatigue, or fever.
Time frame: First 14 days after vaccination
Comparison of Geometric Mean Titer (GMT) by HAI
Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.
Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination
Comparison of Geometric Mean Ratios (GMR) by HAI
GMTs compared to each other as a ratio of the pre- and post-vaccine titers and as the ratio post-last dose to 9 months later. GMRs were compared pre- to post-vaccination and post- vaccination to 9 months later.
Time frame: Pre-vaccination, post-vaccination and 9 months after vaccination