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

18 Years
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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To assess whether patients can mediate an appropriate immune response KLH

Outcome Time Frame:

Week 4 post vaccination

Safety Issue:


Principal Investigator

Jeffrey Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

March 2012

Related Keywords:

  • Cancer
  • Tetanus



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