Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
Condition: Breast Cancer; Lung Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: inactivated influenza vaccine and the 23- valent pneumococcal vaccine; inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)
Intervention description: Patients >65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23-valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured, as will serum IgG levels and IgG subtypes. At 8-16 weeks after vaccination, post vaccine titers, CBC, lymphoid phenotype and function will be assessed.; MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly)and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured. At approximately 8-16 weeks after vaccination, post vaccine titers will be measured again.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Breast; Lung; Prostate; Vaccine

Summary:

      Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can
      get these infections. However, some people are at greater risk from the disease, including
      people 65 and older, the very young, and people with special health problems such as people
      with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can
      cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart
      attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the
      blood (bacteremia), and the covering of the brain (meningitis). People with the special
      health problems mentioned above are even more likely to die from the disease. Although there
      are drugs to treat these infections, they are not always effective. This makes prevention of
      the disease through vaccination even more important.

      This study will look at the body's response to influenza and pneumococcal vaccination. We
      want to see how well they it will protect. Immunization is the same as vaccination. Our goal
      is to protect as much as we can. We are doing the study because more information is needed to
      see how well older patients with cancer respond to these vaccines and how well they protect
      against disease caused by influenza and pneumococcus.
    

Eligibility criteria:

        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