The primary objective of the ISS T-002 study is to evaluate the immune response induced on HIV-1 infected patients under successful HAART treatment and the secondary objective is to continue the assessment of the product safety by monitoring any possible side effects occurring during the trial. The therapeutic vaccine candidate is based on the use of a protein of the virus called Tat, which is essential for the viral replication and propagation (Tat protein allows the virus to reproduce and to spread in the infected organism, and for this reason it is called “regulatory protein”). Tat protein is endowed with a more preserved structure in the parts recognized by the immune system compared to the proteins of the viral envelope, called “structural proteins”, already used in other clinical trials. This means that the protein does not substantially modify during the infection and its structure is very similar in subjects coming from different geographical areas (i.e. Africa), which are characterized by the prevalence of different viral clades from those present in the Industrialized Countries.
The ISS T-002 study is open label, thus every participant will be informed on the characteristics of the product which is administered to him/her, which can vary in terms of dose and number of administrations, according to the randomization arm (casual assignment) to which every participant will be assigned. The study does not foresee any administration of placebo. The treatment regimens of the protocol are the following:
- Tat 7,5 µg, 3 intradermal injections
- Tat 30 µg, 3 intradermal injections
- Tat 7,5 µg, 5 intradermal injections
- Tat 30 µg, 5 intradermal injections
In view of the urgency to improve HIV treatment and based on the ongoing results showing that immunization with Tat can act in synergy with HAART and effectively reverts biomarkers of HIV disease that persist under HAART alone, with higher therapeutic effects in the more immune dysregulated subjects, a protocol amendment was approved by the Ethical Committees to increase the number of patients from 128 to 160 and to include more immune compromised individuals.
The requirements to participate in the trial are specified in the clinical protocol (click here for the clinical protocol synopsis). The satisfaction of such requirements (inclusion and exclusion criteria) makes it possible to participate in the trial. Such criteria have been determined by the researchers and doctors of the experimental team to the purpose of facilitating the interpretation of the experimentation results.
The ISS T-002 trial enjoys the support of three independent advisory boards (International Advisory Board, Data Safety Monitoring Board, Community Advisory Board).
For the final results about the effectiveness of the vaccine we will have to wait till the end of the Phase III clinical trial, which will be consequent to a positive result of the Phase II. It is key to remember that, as far as we know, the vaccination does not prevent the transmission of the virus, therefore the participants to the experimentation will have to continue avoiding any risky behavior (unprotected sexual intercourses and using contaminated needles).
For any information about the study you can refer to the Telefono Verde AIDS of the Istituto Superiore di Sanità (800 861 061, from 10:00 a.m. to 6:00 p.m. until December 10th 2010, and after this date, from 1:00 p.m. to 6:00 p.m.) and, if you are interested in joining the study, it is possible to get in contact with the participating Clinical Centers to program the preliminary interview and the evaluations needed to assess the suitability to trial participation.
Click here for information on how to contact participating Clinical Sites.