Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy

Saad Jamshed MD105 enrolled

Overview

The safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

105

Conditions

Cancer Influenza Viral Infections

Interventions

Standard Trivalent Influenza VaccineBIOLOGICAL

Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.

High-Dose Influenza VaccineBIOLOGICAL

Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years old to less than 65 years old 2. Subjects with malignancy must be receiving chemotherapy 3. Medically stable 4. Able to understand and willingness to sign a written informed consent 5. Able to comply with study procedures 6. Life expectancy of more than 3 months 7. Adequate organ function: * ANC \>1000/mm3 * Platelet \>100,000/uL * Creatinine \<2 mg/dL * AST and ALT \<3 times the ULN Exclusion Criteria: 1. Allergy to eggs 2. Prior allergy to Influenza Vaccine 3. History of Guillain-Barre Syndrome 4. Current febrile illness 5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV) 6. Autologous or Allogenic Stem Cell Transplant with in a year 7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)

Locations (2)

Rochester General Hospital

Rochester, New York, United States

Lipson Cancer Center Linden Oaks Medical Campus

Rochester, New York, United States

Outcomes

Primary Outcomes

The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.

Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.

Time frame: Baseline and 28 days

Secondary Outcomes

The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.

Time frame: 28 days

The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.

Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.

Time frame: Baseline and 28 days

Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.

Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Time frame: 7 days

Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.

Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine

Time frame: 7 days

Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.

Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine

Data from ClinicalTrials.gov

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