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Vaccination With Tetanus and KLH to Assess Immune Responses.

This study is currently recruiting participants.
Study NCT00000105.   Last updated on March 5, 2008.   Information provided by National Center for Research Resources (NCRR)

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Descriptive Information Fields
Brief Title  Vaccination With Tetanus and KLH to Assess Immune Responses.
Official Title 
Brief Summary

The purpose of this study is to learn how the immune system works in response to vaccines. We will give the vaccines to subjects who have cancer but have not had treatment, and to patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines while they are on treatments which boost the immune system (like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting drugs, we do not yet know if they improve the body's immune system to respond better to a vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control subjects to get a good measure of the normal immune response. We will compare the patients and the healthy volunteers to study how their immune systems respond to the vaccines.

There are several different types of white cells in the blood. We are interested in immune cells in the blood called T-cells. These T-cells detect foreign substances in the body (like viruses and cancer cells). We are trying to learn more about how the body fights these foreign substances. Our goal is to develop cancer vaccines which would teach T-cells to detect and kill cancer cells better. We know that in healthy people the immune system effectively protects against recurrent virus infection. For example, that is why people only get "mono" (mononucleosis) once under normal circumstances. When the body is infected with the "mono" virus, the immune system remembers and prevents further infection. We are trying to use the immune system to prevent cancer relapse. To test this, we will give two vaccines which have been used to measure these immune responses. Blood samples will be studied from cancer patients and will be compared to similar samples from normal subjects.

Detailed Description
Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cancer
Intervention  Biological: Tetanus and KLH
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Patients must have a diagnosis of cancer of any histologic type.
  • Patients must have a Karnofsky performance status great or equal to 70%.
  • Patients must have an expected survival for at least four months.
  • Normal healthy volunteers to serve as control for this study.
  • All patients must sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
Gender Both
Ages 18 Years to 55 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Dr. Jeffrey Miller     1-612-625-3636        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000105
Organization ID NCRR-M01RR00400-0626
Secondary IDs †† M01RR00400
Study Sponsor  National Center for Research Resources (NCRR)
Collaborators ††
Investigators 
Information Provided By National Center for Research Resources (NCRR)
Verification Date March 2008
First Received Date  November 3, 1999
Last Updated Date March 5, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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