No objective responses were noted. Eighteen percent of patients had stable disease for >6 months with vaccine alone, and 30% had stable disease for >6 months with vaccine and cytokine. Median overall survival was 19.3 months for all patients and 22.4 months for patients receiving vaccine and cytokine. 22 Abbreviated Title: Phase I MVA -Brachyury -TRICOM Version Date: September 14, 2016 Confidential The TroVax v accine has also been evaluated in 4 small single -arm trials in patients with metastatic colorectal cancer. Antibody and T -cell responses, as well as stable disease, were noted along with some complete responses and partial responses in the various trials. In a trial involving the combination of TroVax with FOLFIRI chemotherapy, 11/17 patients were considered evaluable for immunologic evaluation. O f these, 6 had complete or partial responses as well as T -cell or antibody responses to vaccine. These immune responses correlated with clinical benefit. The TG4010 vaccine was also evaluated in prostate cancer patients (n = 40) with biochemical failure. Thirteen of 40 patients had a more than 2-fold improvement in PSA doubling time, and 10 patients had their PSA stabilized over 18 months. This vaccine has also been evaluated in patients (n = 65) with stage 3/4 non-small cell lung cancer. In this randomized phase II study, patie nts in arm 1 received vaccine in combination with chemotherapy; in arm 2 patients received vaccine monotherapy until disease progression, followed by vaccine plus the same chemotherapy. The median overall survival in arm 1 was 12.7 months versus 14.9 months for arm 2. One-year overall survival rate was 53% for arm 1 and 60% for arm 2. 1.2.14 Safety of Recombinant MVA V ectors Safety data from the first clinical trials of recombinant MVA recorded no serious or severe adverse events. 26 MVA- METRAP (fusion between the string of multiple defined T- cell epitopes originally developed for the VLPs (known as ME), and a complete P. falciparum liver stage antigen, thrombospondin relative adhesive protein (TRAP)) was administered to 26 healthy volunteers aged 18–55 by intradermal injection at a dose of 3 × 107 pfu, in some cases following priming with a DNA vaccine also expressing METRAP administered either intramuscularly or by gene gun. Most adverse events were mild: flu -like illness, nausea, lethargy, or lymphadenopathy.