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

St. Jude Children's Research Hospital

Status and phase: Completed; Phase 2

Conditions: HIV; Cancer

Treatments: Biological: Fluzone High Dose Vaccine; Biological: Fluzone Standard Dose Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01205581

FLUHD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 6 patient groups

Leukemia-HD

Active Comparator group

Description:

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

Treatment:

Biological: Fluzone High Dose Vaccine

Leukemia-SD

Active Comparator group

Description:

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

Treatment:

Biological: Fluzone Standard Dose Vaccine

Solid Tumor-HD

Active Comparator group

Description:

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

Treatment:

Biological: Fluzone High Dose Vaccine

Solid Tumor-SD

Active Comparator group

Description:

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

Treatment:

Biological: Fluzone Standard Dose Vaccine

HIV-HD

Active Comparator group

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.

Treatment:

Biological: Fluzone High Dose Vaccine

HIV-SD

Active Comparator group

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.

Treatment:

Biological: Fluzone Standard Dose Vaccine