Investigational product |
Biotechnological Vaccine
|
| Patients |
128 in Italy |
| Duration |
Project duration: at least 2 years
Duration for each patient: 1 year
|
| Dedicated Personnel |
About 100 persons, with at least 50 individuals distributed between ISS and cooperating companies (CNAIDS, Core Lab, TVA, Opera, Diatheva, Injectalia), and at least 50 (5/site) at the 10 Clinical Centres
|
| Visits |
At least 1280 clinical visits |
Clinical Centres |
10 (RM, FI, MI 2, BS, BA, LT, TO, MO, FE) |
| Laboratory |
Centralized (Core Lab IFO S. Gallicano, Rome)
A total of 14.000 person-hours per year are foreseen
|
Biological samples delivery from Clinical Centres to the Core Laboratory at Rome |
Dedicated Courier to the release within 8 hours
About 600 deliveries/year at RT and 140 deliveries/year at CT (- 80 °C)
|
| Laboratory tests |
Immunological testing (about 17000 tests)
|
| Production |
Diatheva, Università degli Studi di Urbino |
| Formulation and packaging |
Injectalia Biopharma, (Pomezia, Rome)
(About 700 vaccine vials will be used for the trial)
|
| Vaccine delivery to Clinical Centres |
Specialized Courier for delivery at - 80 °C
(About 650 deliveries / year)
|
| Monitoring and Data Managment Activities |
Contract Research Organization Opera Srl (Genova)
(A total of 18000 person-hours per year are foreseen)
|
| Clinical Data |
Electronic Case Report Forms (Oracle Remote Data Capture). The study will imply the storage and the management for about 10 billions of data |
| Insurance |
HDI-Gerling |
| Psychological support to the patients |
Psychological Evaluation Protocol coordinated by “Università Vita-Salute” (San Raffaele, Milan) |
