Vaccination With Tetanus and KLH to Assess Immune Responses.

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Nov 3, 1999

Keywords

ClinConnect Summary

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 t...

Gender

ALL

Eligibility 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.

Trial Officials