search
Back to results

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

Primary Purpose

HIV, Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluzone High Dose Vaccine
Fluzone Standard Dose Vaccine
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Fluzone, Trivalent Influenza Vaccine

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Leukemia-HD

Leukemia-SD

Solid Tumor-HD

Solid Tumor-SD

HIV-HD

HIV-SD

Arm Description

Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.

Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.

Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.

Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Comparison of Geometric Mean Titer (GMT) by HAI
Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.
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.

Full Information

First Posted
September 17, 2010
Last Updated
September 20, 2016
Sponsor
St. Jude Children's Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01205581
Brief Title
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Official Title
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Cancer
Keywords
Fluzone, Trivalent Influenza Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Leukemia-HD
Arm Type
Active Comparator
Arm Description
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Arm Title
Leukemia-SD
Arm Type
Active Comparator
Arm Description
Subjects with a diagnosis of leukemia will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Arm Title
Solid Tumor-HD
Arm Type
Active Comparator
Arm Description
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone High Dose Vaccine and evaluated for development of immune responses.
Arm Title
Solid Tumor-SD
Arm Type
Active Comparator
Arm Description
Subjects with a diagnosis of solid tumor will be vaccinated twice with Fluzone Standard Dose Vaccine and evaluated for development of immune responses.
Arm Title
HIV-HD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIV-SD
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Fluzone High Dose Vaccine
Other Intervention Name(s)
Fluzone-HD
Intervention Description
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
Intervention Type
Biological
Intervention Name(s)
Fluzone Standard Dose Vaccine
Other Intervention Name(s)
Fluzone-SD
Intervention Description
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Primary Outcome Measure Information:
Title
Rate of Seroconversion After 1 Dose of Vaccine
Description
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
Title
Rate of Seroprotection After 1 Dose of Vaccine
Description
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
Title
Number of Participants Achieving Seroprotection After Second Dose of Vaccine
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Reporting Grade 3 and Grade 4 Adverse Events Possibly, Probably, or Definitely Attributable to Fluzone or Fluzone HD
Description
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
Title
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone HD
Description
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.
Time Frame
at least 21 days after each dose of vaccine
Title
Rate of Sero-conversion for 1 Dose vs. 2 Doses of Fluzone SD
Description
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
Title
Rate of Vaccine Response by Seroconversion Compared by Absolute Lymphocyte Count (ALC)
Description
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
Title
Rate of Vaccine Response by Seroprotection Compared by Absolute Lymphocyte Count (ALC)
Description
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
Title
Number of Local Reactogenicity Events After First Dose
Description
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
Title
Number of Local Reactogenicity Events After Second Dose
Description
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
Title
Number of Systemic Reactogenicity Events After First Dose
Description
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
Title
Number of Systemic Reactogenicity Events After Second Dose
Description
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
Title
Comparison of Geometric Mean Titer (GMT) by HAI
Description
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
Title
Comparison of Geometric Mean Ratios (GMR) by HAI
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A McCullers, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

Learn more about this trial

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

We'll reach out to this number within 24 hrs