Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Safety and tolerability of the vaccine candidate CIGB-247, for which the record the following parameters: a) Clinical adverse events (Event Number, Type and Frequency: Yes, No, intensity: mild, moderate, severe). Measuring time: a week after each of the first 8 immunizations and at weeks 12 (re-immunization), 13 and 16 (one week and one month after vaccination booster), but also at other times it is presented some adverse event. b) Laboratory tests (valores numéricos de pruebas hematology and biochemistry). Measuring time: at weeks 1, 7, 12, 13 and 16.
Key secondary outcomes:
Immune response to the vaccine (determination of serum titers of anti-VEGF; percent of inhibition - binding VEGF and its receptor; ELISPOT for interferon gamma: average number of points). Measuring time: in weeks 1, 5, 7, 9, 12, 13 and 16. Quality of life of patients by applying the questionnaire EORTC QLQ-C30 (worse, unchanged, slightly improved, moderately improved, much improved). Measuring time: in weeks 9 and 16. Tumor Response Assessment, if applicable (tumor diameter). Measuring time: at week 16. Ophthalmologic evaluation, if applicable (visual acuity, contrast sensitivity, fundus, retinal sensitivity, optical coherence tomography). Measuring time: at week 13.