Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01205581
First received: September 17, 2010
Last updated: September 5, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
HIV
Cancer
Biological: Fluzone High Dose Vaccine
Biological: Fluzone Standard Dose Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Rate of Seroconversion After 1 Dose of Vaccine [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ] [ Designated as safety issue: No ]
    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.

  • Rate of Seroprotection After 1 Dose of Vaccine [ Time Frame: at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose ] [ Designated as safety issue: No ]
    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.

  • Rate of Seroprotection After Last Dose of Vaccine [ Time Frame: 21 to 42 days after last dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Number of participants reporting grade 3 and grade 4 adverse events possibly, probably, or definitely attributable to Fluzone or Fluzone HD.

  • Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD [ Time Frame: at least 21 days after each dose of vaccine ] [ Designated as safety issue: No ]

    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.


  • Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD [ Time Frame: at least 21 days after each dose of vaccine ] [ Designated as safety issue: No ]

    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.


  • Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC) [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ] [ Designated as safety issue: No ]
    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.

  • Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC) [ Time Frame: ALC at baseline and vaccine response at least 21 days after last dose of vaccine ] [ Designated as safety issue: No ]
    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.

  • Number of Local Reactogenicity Events After First Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Number of Local Reactogenicity Events After Second Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Number of Systemic Reactogenicity Events After First Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Number of Systemic Reactogenicity Events After Second Dose [ Time Frame: First 14 days after vaccination ] [ Designated as safety issue: Yes ]
    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.

  • Comparison of Geometric Mean Titer (GMT) by HAI [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ] [ Designated as safety issue: No ]
    Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.

  • Comparison of Geometric Mean Ratios (GMR) by HAI [ Time Frame: Pre-vaccination, post-vaccination and 9 months after vaccination ] [ Designated as safety issue: No ]

    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.



Enrollment: 85
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Leukemia-HD
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-HD
Active Comparator: Leukemia-SD
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-SD
Active Comparator: Solid Tumor-HD
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-HD
Active Comparator: Solid Tumor-SD
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-SD
Active Comparator: HIV-HD
Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-HD
Active Comparator: HIV-SD
Subjects with a diagnosis of human immunodeficiency virus (HIV) will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Biological: Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Other Name: Fluzone-SD

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
  • Written informed consent (and assent, if applicable) obtained.
  • Participant has a diagnosis of cancer or HIV.
  • If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks

Exclusion Criteria

  • Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
  • History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
  • Not willing to agree to acceptable birth control for three months after study immunization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205581

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Jonathan A McCullers, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01205581     History of Changes
Other Study ID Numbers: FLUHD
Study First Received: September 17, 2010
Results First Received: July 24, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Fluzone
Trivalent Influenza Vaccine

ClinicalTrials.gov processed this record on October 01, 2014