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.
Observational Model: Case Control, Time Perspective: Prospective
To assess whether patients can mediate an appropriate immune response KLH
Week 4 post vaccination
Jeffrey Miller, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo||Minneapolis, Minnesota 55455|