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Table 2 Vaccination (with M-FP or placebo), testing and follow up

From: Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835]

  Day Weeks Months Every 3 Months 1 year Every year
  1 2 4 6 8 10 12 4 5 6 7 8 9    
Staging of the disease +                
Vaccine + + + + + + +    +    +    
T cell test +a    +b    +c    +d    +e   +f +g, h
Antibody test +a    +b    +c    +d    +e   +f +g, h
Clinical examination +       +    +    + +   +
Follow-up tests +          +      + +
Bone scan and mammography +                +
  1. For T cell tests and antibody tests sample numbers are highlighted within the box as superscript, indicating time points at which immunological tests were carried out: afirst injection; bweek 6 (2 weeks after the third injection); cweek 12 (2 weeks after the sixth injection); d6 months (3 months after the seventh injection); e9 months (3 months after the eighth) injection; f1 year (3 months after the final [ninth] injection); g2 years (1 year and 3 months after the final injection); h3 years (2 years and 3 months after the final injection). Day 1 is the day of first vaccination. Follow up was every 3 months for 5 years. Antibody test = blood for testing antibody levels; Follow-up tests = laboratory tests, chest X-ray, upper and lower abdominal ultrasound; M-FP, oxidized mannan conjugated to MUC1 fusion protein; T cell test = PBMC for testing IFN-γ; Vaccine = M-FP or placebo administered subcutaneously.