Date: 2014-12-10
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in PLOS ONE
Company: Intercell (Austria), now Valneva - Statens Serum Institut (Denmark)
Product: H1/IC31® (H1IC vaccine candidate from SSI is a recombinant subunit vaccine based on two important TB antigens resulting from SSI’s research pipeline combined with Intercell’s proprietary adjuvant IC31® and ultimately targeted against adults and adolescents.)
Action
mechanism: H1/IC31® is a recombinant subunit vaccine based on two important TB antigens (Ag85B and ESAT-6) developed by SSI and formulated with Valneva’s proprietary adjuvant IC31® ultimately targeted toward adults and adolescents. SSI is conducting a second Phase II clinical study to assess the safety and immunogenicity of the H1/IC31® vaccine candidate in 240 adolescents. Further Phase I or I/II trials are also being conducted by SSI and their partners, including Sanofi Pasteur and AERAS, with two other vaccine candidates formulated with Valneva’s IC31® adjuvant.
Disease: tuberculosis
Therapeutic area: Infectious diseases
Country: South Africa, Tanzania
Trial
details: The randomised, double-blind, clinical trial evaluating the immunogenicity and safety of two doses of an adjuvanted TB subunit vaccine candidate, H1IC (a combination of SSI’s Ag85B-ESAT-6 + Intercell’s IC31®), in HIV-positive individuals, will be conducted in South Africa and Tanzania.
Latest
news: * On December 10, 2014, Valneva announced that the Statens Serum Institut’s (SSI) novel Tuberculosis (TB) vaccine candidate H1/IC31® formulated with Valneva’s proprietary adjuvant IC31® showed good safety and immunogenicity in Phase II clinical trial in HIV-infected adults. The results of the randomized, double-blind, clinical phase II trial initiated and led by Prof Churchyard from the Aurum Institute NPC, South Africa, were published in an article written by Dr. Reither of the Swiss Tropical and Public Health Institute (TPH) in the scientific online publication PLOS ONE*. The aim of the trial, which was conducted in South Africa and Tanzania, was to evaluate the immunogenicity and safety of two doses of the TB vaccine candidate H1/IC31® in 48 HIV-positive adults (between 18 and 55 years of age). According to the article, the vaccine candidate H1/IC31® was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm3. It did not affect HIV viral load and induced a specific and durable immune response against TB. Valneva is entitled to receive a share of the profits coming from SSI’s revenues related to the use of IC31® * On January 11, 2012, Intercell AG and Statens Serum Institut (SSI) announced the start of the first Phase II study within their collaboration to develop vaccines against Tuberculosis (TB). The study is funded by EDCTP (European and Developing Countries Clinical Trials Partnership) and conducted in collaboration with Aurum Institute, Ifakara Health Institute, Swiss Tropical and Public Health Institute, London School of Hygiene and Tropical Medicine and the South African TB Vaccine Initiative. First results are expected in 2013. A second Phase II clinical study is being planned to assess the safety and immunogenicity of the vaccine candidate in healthy adolescents. Previous Phase I clinical trials in Europe and Africa have demonstrated that SSI and Intercell’s collaborative novel investigational TB vaccine is safe and very immunogenic in different populations. The collaboration between SSI and Intercell in the field of Tuberculosis currently includes three clinical vaccine candidates, all formulated with Intercell’s IC31® adjuvant: H1IC, now entering Phase II, H4IC, currently in Phase I (partnered with Sanofi and AERAS, “AERAS 404”), and H56IC, currently in a Bill and Melinda Gates Foundation-funded Phase I in partnership with AERAS and the South African Tuberculosis Vaccine Initiative.
