UAB 9405 
March 16, 1994 
PAGE - 17 
8.2 Evaluation During Study 
Following vaccination, patients will be observed for local reaction at the injection 
sites as well as examination of the regional lymph nodes (Days 1, 2, 8, and 15). 
During each clinical toxicity evaluation (days 1,2, 15, 29, 43, and 57) the NCI 
Common Toxicity Criteria form provided as Appendix A (Attachment 3) will be 
used as a checklist to identify and grade toxicity. Serial serum samples will be 
drawn to evaluate for an antibody response to CEA as well as CEA antigen. 
Blood for cellular immune studies will be obtained at Day 29 and 57 (four and 
eight weeks) and assayed for T cell mediated immune response to CEA. If any 
assay for cellular immunity is positive, a repeat study will be carried out within 4 
weeks of the positive assay date. 
8.3 Antibody Response to CEA 
The Humoral Immunity Laboratory will carry out separate assays for antibody 
response to CEA. Each assay will be run with the pre-therapy and post-therapy 
serum samples on each patient on the same day to avoid inter-assay variability. 
The assays are; 
• solid phase ELISA using anti-IgG and anti-IgM detectors 
• double antigen radiometric assay utilizing solid phase and I-CEA 
detector 
Sera with positive antibody assay results to CEA will be tested for ability to 
mediate ADCC and complement mediated lysis of CEA positive target cells. 
These assays are described in Appendix E. 
8.4 Cellular Immune Response to CEA 
The Cellular Immunology Laboratory will carry out assays for cellular immunity 
to CEA. The assays are: 
• lymphoblastic transformation 
• lymphokine release assay (IL-2) 
• lymphokine release assay (IL-6) 
8.5 Circulating Antigen Levels 
Serum samples will be assayed for levels of CEA as indicated in section 8.1 using 
a Hybritech commercial radiometric assay kit. 
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