Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00741039
First received: August 22, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Prostate Cancer
Biological: inactivated influenza vaccine and the 23- valent pneumococcal vaccine
Biological: inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Determine resp rate of pts > or = to 65 yrs diag with common adult tumors to the killed influenza including the killed H1N1 & or the 23-valent pure polysaccharide vaccine, Pneumovax, c/w to healthy controls > or = to 65 yrs w/o cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether a relationship exists between in vitro parameter(s) of immune reconstitution and vaccine response. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: August 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1,
Patients > or = to 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).
Biological: inactivated influenza vaccine and the 23- valent pneumococcal vaccine
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.
Experimental: 2
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).
Biological: inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741039

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Trudy Small, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00741039     History of Changes
Other Study ID Numbers: 08-005
Study First Received: August 22, 2008
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Lung
Prostate
Vaccine

Additional relevant MeSH terms:
Prostatic Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014