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Vaccination With Tetanus and KLH to Assess Immune Responses.

This study has been terminated.
(Replaced by another study.)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00000105
First received: November 3, 1999
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Cancer
Biological: Intracel KLH Vaccine
Biological: Biosyn KLH
Drug: Montanide ISA51
Biological: Tetanus toxoid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • To assess whether patients can mediate an appropriate immune response KLH [ Time Frame: Week 4 post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tetanus Response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

analysis of blood samples before and 4 weeks postvaccination


Enrollment: 112
Study Start Date: July 2002
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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: Biosyn KLH
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
Other Names:
  • Immunocyanin
  • IMMUCOTHEL®
  • VACMUNE®
Biological: Tetanus toxoid
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Other Name: PUROGENATED®
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: 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 Name: Montanide ISA 51 VG
Biological: Tetanus toxoid
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Other Name: PUROGENATED®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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

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.
  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: NCT00000105

Locations
United States, Minnesota
Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Jeffrey Miller, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00000105     History of Changes
Other Study ID Numbers: 2002LS032, MT1999-06
Study First Received: November 3, 1999
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Freund's Adjuvant
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014