THURSDAY, SEPTEMBER 29, 2016

Valneva's first Phase II trials on TB vaccine show promise

European biotechnology company Valneva SE said recently that its Statens Serum Institut’s (SSI) tuberculosis (TB) vaccine candidate H1/IC31, formulated with Valneva’s proprietary adjuvant IC31, showed positive results in Phase II trials.

The Phase II randomized, double-blind clinical trials were conducted using HIV-infected adults in South Africa and Tanzania between the ages of 18 and 55 as subjects.

The findings from the trials were published in a recent article in the journal PLOS ONE.

The goal of the trial was to evaluate the immunogenicity and safety of two doses of the TB vaccine, which was safely tolerated and safe in HIV-infected individuals with a CD4+ lymphocyte count greater than 350 cells per cubic millimeter. The study also showed that HIV-infected patients are more at risk than others to become infected with TB due to weakened immune systems.

“These first Phase II results are very encouraging and further validate the performances of our proprietary IC31 adjuvant,” Valneva President and CEO Thomas Lingelbach and Valneva President and Chief Business Officer Franck Grimaud said in a statement. “We are very proud that our technology is playing a key role in the development of a much-needed, novel, efficient TB vaccine.”

SSI will now proceed with a second Phase II clinical study to assess the safety and immunogenicity of the H1/IC31 vaccine candidate in 240 adolescents.

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