Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Neoplasms

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: July 2002
See protocol details

Summary

Principal SponsorMasonic Cancer Center, University of Minnesota
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleVaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses
NCT00000105
Principal SponsorMasonic Cancer Center, University of Minnesota
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

112 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

5 inclusion criteria required to participate
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.
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7 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo

Minneapolis, United StatesOpen Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo in Google Maps
SuspendedOne Study Center