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Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses
Sponsor study identifier
Secondary identifiers
OTHER · Blood and Marrow Transplantation Program
observational
112
1 country
1
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 3, 1999
Actual (reported)November 4, 1999
Actual (reported)July 2002
Date type not reportedThis date has not been verified as actual or estimated.
March 2012
Actual (reported)March 2012
Actual (reported)To assess whether patients can mediate an appropriate immune response KLH
Week 4 post vaccination
Tetanus Response
Throughout study
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).
Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
* Normal volunteers * Patients with Cancer (breast, melanoma, hematologic) * Transplant patients (umbilical cord blood transplant, autologous transplant) * Patients receiving other cancer vaccines
Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo
Minneapolis, Minnesota, 55455, United States
analysis of blood samples before and 4 weeks postvaccination
Jeffrey Miller, MD
Masonic Cancer Center, University of Minnesota
112 participants (actual enrollment reported by the registry).
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
July 2002
Date type not reportedThis date has not been verified as actual or estimated.
Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
November 29, 2017
Record last verified: 2017-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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