HUMAN IMMUNODEFICIENCY VIRUS
Safety, tolerability & immunogenicity vaccination study
in HIV-1 positive patients
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of THV01, a therapeutic vaccine at 5.106, 5.107 and 5.108 Transducing Unit (TU) vs. placebo in HIV-1 clade B infected patients under highly active antiretroviral therapy (HAART). 38 patients have been enrolled in 12 sites in Belgium & France, and equally distributed into 3 groups. Each patient has been randomly vaccinated at one of the three doses or a matching placebo, in a 3 to 1 ratio for each dose group.
The completion of the first-ever lentiviral vector vaccination trial in humans, has demonstrated the absence of any serious adverse events and safety concerns. The interim results confirm the remarkable safety profile of THERAVECTYS lentiviral vector technology platform. Detailed results will be presented in peer-reviewed communications.
- The primary objective is to compare the safety and tolerability of THV01 by treatment group and versus placebo from Week 0 to Week 24.
- The secondary objective is to compare and characterize the cellular immune response by treatment group and versus placebo (biological endpoint).
- The exploratory objective is to evaluate and compare the duration of HAART treatment interruption by treatment group and versus placebo from Week 24 (HAART interruption) to Week 88 or early termination (clinical endpoint).
|First database lock after completion of the 2 injections||June 2014|
|Last patient visit (dose 2)||October 2014|
|Database lock||November 2014|
|Interim results||December 2014|
|Last patient visit (dose 3)||October 2015|
|Database lock||November 2015|