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

A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy

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.

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)