Clinical Trials

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science

Infectious diseases

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.
THERAVECTYS HIV clinical trials

objectives

  • 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).

Milestones

Process Date
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
science

cancers

HUMAN T-CELL LEUKEMIA VIRUS TYPE I-INDUCED ADULT T-CELL LEUKEMIA: LYMPHOMA

Safety, tolerability & immunogenicity of a vaccination study
in Adult T-cell Lymphoma/Leukemia induced by HTLV-1

The design of this study is currently being discussed with the European & U.S. regulatory agencies.
Its primary objective will be to compare the safety, tolerability and immunogenicity of THV-02, our therapeutic vaccine candidate.
According to the ongoing positive interaction with the regulatory agencies as well as the promising results of our first vaccine candidate in HIV, we aim at launching a multi-center, Phase I/II trial in patients diagnosed with Acute-type or Lymphoma-type of Adult T-cell Lymphoma-Leukaemia (ATL) induced by Human T-Lymphotropic Virus Type I (HTLV-1) infection.