Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
Inclusion Criteria:
- Patient must be > or = to 65 years of age.
- Patient may be an in patient or an out-patient.
- Patient must have a diagnosis of prostate, lung, or breast cancer.
- Patient must have a life expectancy of > or = to 6 months.
- Patient must have a Karnofsky score of >40%
- Patient must be willing to return to the hospital in 8-12 weeks following
immunization for blood work.
- Patients must have a platelet count of >75,000 for intramuscular injection.
- Patient may be of either gender and of any ethnic background.
- Patients must be able to understand the nature and risk of the proposed study and be
able to sign consent.
Volunteer eligibility:
- MSKCC employee
- Age > or = to 65 years of age
- No previous diagnosis of cancer except basal cell carcinoma, resected Stage I
melanoma or in situ cervical carcinoma. Volunteers may have had a prior history of
other cancers > 3 years which required only local resection, local radiation and/or
hormonal therapy such as androgen blockade.
- Patients must be able to understand the nature and risk of the proposed study and be
able to sign consent.
Exclusion Criteria:
- Karnofsky score <40%:
- Patients who have received an autologous or allogeneic HCT
- Active uncontrolled bacterial or fungal infection
- Hypersensitivity to egg protein (eggs or egg products), chicken proteins, or any
component in the influenza vaccine
- Prior history of any life-threatening reaction after previous administration of any
influenza vaccine or any component such as thimerosal (inclusion of thimerosal varies
among packaging)
- Latex allergy if going to receive the influenza vaccine
- On-going neurologic disorder (mental status change, uncontrolled seizures,
encephalopathy)
- Treatment or planned treatment with cyclophosphamide, ifosphamide, or > or = to 1
mg/kg prednisone or its equivalent 12 weeks within 12 weeks of vaccination.
- HIV-1,2 seropositive patients.
- Patients not signing informed consent.
- Patients receiving the seasonal influenza vaccine may not have had it within 6 months
of enrollment
Healthy controls exclusion:
- Volunteers ineligible to receive either vaccine
- Volunteers unwilling or unable to sign consent
- Hypersensitivity to egg protein (eggs or egg products), chicken proteins, or any
component in the influenza vaccine
- Latex allergy