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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205581
• Other study ID #: FLUHD
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2010
• Last updated: September 20, 2016
• Start date: September 2010
• Est. completion date: August 2013

Study information

• Verified date: July 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• HIV
• Influenza, Human

Intervention

Biological:
• Fluzone High Dose Vaccine
Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
• Fluzone Standard Dose Vaccine
Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose	No
Primary	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.	at least 21 days after first dose, which is given at the time of baseline evaluation visit, and prior to second dose	No
Primary	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.	21 to 42 days after second dose	No
Secondary	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.	From initial vaccine administration through up to 8 months	Yes
Secondary	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.	at least 21 days after each dose of vaccine	No
Secondary	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.	at least 21 days after each dose of vaccine	No
Secondary	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.	ALC at baseline and vaccine response at least 21 days after last dose of vaccine	No
Secondary	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.	ALC at baseline and vaccine response at least 21 days after last dose of vaccine	No
Secondary	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.	First 14 days after vaccination	Yes
Secondary	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.	First 14 days after vaccination	Yes
Secondary	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.	First 14 days after vaccination	Yes
Secondary	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.	First 14 days after vaccination	Yes
Secondary	Comparison of Geometric Mean Titer (GMT) by HAI	Serum antibody levels expressed as the reciprocal of the dilution needed to inhibit hemagglutination in vitro.	Pre-vaccination, post-vaccination and 9 months after vaccination	No
Secondary	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.	Pre-vaccination, post-vaccination and 9 months after vaccination	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital