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

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

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.

ISSN: 1465-542X