Vaccination With Tetanus and KLH to Assess Immune Responses.

November 27, 2017 updated by: Masonic Cancer Center, University of Minnesota

Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will receive each vaccine once only consisting of:

Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).

Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).

Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG) source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml intramuscularly (this arm open 3/18/03).

Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus when it becomes available if there has been no significant change in treatment interventions or overall health status and it is within 3 months of the KLH vaccine.

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Normal volunteers
  • Patients with Cancer (breast, melanoma, hematologic)
  • Transplant patients (umbilical cord blood transplant, autologous transplant)
  • Patients receiving other cancer vaccines

Description

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

Exclusion Criteria:

  • Pregnant or lactating women. Females of child-bearing potential will be asked to take a pregnancy test before receiving vaccines.
  • Serious intercurrent medical illnesses which would interfere with the ability of the patient to carry out the follow-up monitoring program.
  • Immunization should not be administered during the course of any febrile illness or acute infection.
  • Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative.
  • The occurrence of any type of neurologic symptoms to tetanus vaccine in th past.
  • Patients with a history of seafood allergy are excluded from receiving KLH.
  • Subjects who have had tetanus toxoid within the last 7 years are not eligible for tetanus vaccine component of this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm A: Intracel KLH
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).
Biological: Intracel KLH Vaccine
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
Other Names:
  • KLH BCI-ImmuneActivator(TM)
  • IntraCel
Biological: Tetanus toxoid
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Other Names:
  • PUROGENATED®
Arm B: Biosyn KLH
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).
Biological: Tetanus toxoid
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Other Names:
  • PUROGENATED®
Biological: Biosyn KLH
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
Other Names:
  • Immunocyanin
  • IMMUCOTHEL®
  • VACMUNE®
Arm C: Biosyn KLH with Montanide ISA51
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.
Biological: Tetanus toxoid
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Other Names:
  • PUROGENATED®
Biological: Biosyn KLH
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
Other Names:
  • Immunocyanin
  • IMMUCOTHEL®
  • VACMUNE®
Drug: Montanide ISA51
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.
Other Names:
  • Montanide ISA 51 VG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess whether patients can mediate an appropriate immune response KLH
Time Frame: Week 4 post vaccination
Week 4 post vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Tetanus Response
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002LS032
  • MT1999-06 (Other Identifier: Blood and Marrow Transplantation Program)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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