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

Primary Purpose

Breast Cancer, Lung Cancer, Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

inactivated influenza vaccine and the 23- valent pneumococcal vaccine

inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast, Lung, Prostate, Vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

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).

Outcomes

Primary Outcome Measures

Determine Response Rate of Patients > or = to 65 Yrs Diagnosed

For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).

Secondary Outcome Measures

Full Information

NCT ID

NCT00741039

First Posted

August 22, 2008

Last Updated

October 19, 2015

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00741039

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lung Cancer, Prostate Cancer

Keywords

Breast, Lung, Prostate, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

inactivated influenza vaccine and the 23- valent pneumococcal vaccine

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.

Intervention Type

Biological

Intervention Name(s)

inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Determine Response Rate of Patients > or = to 65 Yrs Diagnosed

Description

Time Frame

8-16 weeks following vaccination.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Trudy Small, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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