|
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
|
+
| | | | | | | | | | | | | | |
+
|
- 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.