italian HIV AIDS vaccine English HIV AIDS vaccine
HIV AIDS TAT Vaccines logo image
 
  HOME
 
  HIV and AIDS
    What is "AIDS"
    Routes of infection
    First symptoms
    Having AIDS
    Can AIDS be cured?
   
  The Need for Vaccines
    AIDS in the World
    AIDS in Africa
   
  HIV-1 Tat:
  A NOVEL APPROACH TO VACCINATION
    Scientific Background & Rationale
    HIV-1 Tat Protein
    Pre-clinical Studies
    Clinical Studies
    International Collaborations
 
  TAT VACCINE CANDIDATES
 
    1st. Gen.: Tat alone
    2nd Gen.: Tat+Microparticles
    2nd Gen.: Tat+Env
    Discovery Phase Leads
  MANUFACTURING
  CLINICAL TRIAL PLANS
  INTELLECTUAL PROPERTY
  NEWS
 
 
 
  T-002: Protocol synopsis
ISS T-002: SECTION INDEX
PROTOCOL T-002
Investigational product
Biotechnological Vaccine
Country
Italy
Patients
160
Duration
Project duration: at least 4 years
Duration for each patient: 3 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 2720 clinical visits
Clinical Centres
11 (RM, FI, MI 2, MB,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 for shipment delivery within 8 hours
About 720 deliveries/year at RT and 175 deliveries/year at CT (- 80 °C)
Laboratory tests

Immunological, virological and safety testing (about 20.000 tests)

Production Diatheva, Università degli Studi di Urbino
Formulation and packaging

Injectalia Biopharma, (Pomezia, Rome)
(About 900 vaccine vials will be used for the trial)

Vaccine delivery to Clinical Centres

Specialized Courier for delivery at - 80 °C
(About 810 deliveries / year)

Monitoring and Data Managment Activities

Contract Research Organization Opera Srl (Genova)
(A total of 42.500 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)
 

 

ITALIAN SUPPORTING
INSTITUTIONS
 
   
  NATIONAL AIDS CENTER  
       
  NATIONAL INSTITUTE OF HEALTH  
       
  MINISTRY OF HEALTH  
       
  MINISTRY OF FOREIGN AFFAIRS  
       
  SAN GALLICANO HOSPITAL  
       
  UNIVERSITY OF URBINO  
       
       
   
 
   
      Government agencies  
       
      Patients  
       
      Scientists  
       
      Professionals  
       
      Industry  
       
      Basic scientific dictionary  
       
      Faqs  
       
  SCIENTIFIC PUBLICATIONS  
       
  USEFUL LINKS  
       
  CONTACT US