InnaVirVax: Phase I/IIa clinical study of its VAC-3S immunotherapeutic vaccine for treatment of HIV infection achieved primary endpoint

05-Dec-2012 - France

InnaVirVax has just announced successful completion of the first clinical development phase for VAC-3S immunotherapy in the treatment of HIV infections.
A phase I/IIa dose escalation study was performed in 24 patients living with HIV whose CD4 T-lymphocyte levels were higher than 200/mm3 and who were under antiretroviral therapy [ART].

The treatment was administered in 3 injections at 4-week intervals. The primary endpoint of this study was to assess the safety and tolerability of VAC-3S, four weeks after the third injection. Secondary endpoints included an evaluation of the immune response, the long-term safety of the treatment and the monitoring of different biological markers of infection (including viral load and the CD4 T-lymphocyte count). The study was carried out under double-blinded conditions in two AP-HP (Paris Public Hospitals System) academic reference clinical centers at Hôpital de la Pitié Salpêtrière and Hôpital Cochin.

The results showed that VAC-3S was well tolerated, thus meeting the primary endpoint of the study.

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