UAB 9405 
March 16, 1994 
PAGE - 12 
6.2.2 Treatment Schedule 
Group #1 0.05 mg CEA polynucleotide vaccine into each deltoid 
muscle X 1 (Day 1 ) 
#2 0.15 mg CEA polynucleotide vaccine into each deltoid 
muscle X 1 (Day 1) 
#3 0.5 mg CEA polynucleotide vaccine into each deltoid 
muscle X 1 (Day 1) 
#4 0.15 mg CEA polynucleotide vaccine into each deltoid 
muscle on Days 1 , 22 and 43 
#5 0.5 mg CEA polynucleotide vaccine into each deltoid 
muscle on Days 1, 22 and 43 
6.3 Specific Therapeutic Plan 
6.3.1 All vaccinations will be carried out in the out-patient department of the 
Clinical Research Center of the University of Alabama at Birmingham. 
6.3.2 Each patient will receive bilateral intramuscular (deltoid muscle) 
injections of the CEA polynucleotide vaccine. The use of bilateral 
injections for each immunization is to reduce the likelihood that a 
technical failure of delivery into the body of the muscle will occur since 
such a delivery would preclude gene expression and immune response. 
Secondly, gene expression has been reported to be greater if more than one 
site is used (27). 
The intramuscular injection technique will utilize standard aseptic 
technique utilizing a 1 ml syringe, 25 g needle and a volume of <0.5 ml for 
each injection. The patient will be monitored (vital signs Q 15 minutes 
times 4 and Q hour times 3) for four hours for local pain, discomfort or 
signs of inflammation and be re-examined 24 hours later to monitor for 
any local or systemic signs of inflammation or toxicity. The patient will 
be monitored by phone conversations at 48 and 72 hours and return for 
visits/exams weekly times 2 for evaluation for toxicity and blood samples 
as detailed later. Reporting of adverse reaction to the FDA and IRB will 
be strictly followed. 
6.4 Order of Patient Entry 
Three patients will enter the initial dose level treatment group and all 
patients will be monitored for at least two weeks before accrual to the next 
dose level can begin. The follow-up requirement for the multidose groups 
(Groups IV and V) will be eight weeks before moving to the next dose 
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