Statens Serum Institut, Intercell, and Aeras announce the initiation of a clinical trial for a novel TB vaccine candidate

SSI's novel tuberculosis subunit vaccine HyVac4IC31 (AERAS404) enters phase I clinical trial in BCGvaccinated individuals

06-Dec-2007

Statens Serum Institut (SSI), Intercell, and Aeras announced that SSI's novel prophylactic vaccine HyVac4IC31 (AERAS404) against TB have entered phase I clinical trials in BCGvaccinated individuals. The clinical trial has been initiated at the Karolinska Institute (Stockholm).

The new TBvaccine HyVac4IC31 (AERAS404) supported by and codeveloped with AERAS is based on the H4antigen which in the preclinical phase has shown remarkable activity as a BCG booster.

"With the initiation of this clinical trial on the TB vaccine molecule HyVac4 we are intensifying our efforts to provide the best possible TB vaccine to control the global TB epidemic" says Professor Peter Andersen, Vice President for Vaccine R&D at the SSI "Our proprietary adjuvant IC31® has proven to be safe and to induce a strong and sustained immune response that has not yet been seen before in comparable preclinical and clinical vaccine settings. We are confident that this further vaccine candidate will fulfil the expectations in the clinical development to target this high unmet medical need", comments Intercell´s Chief Scientific Officer Alexander von Gabain.

HyVac4 is a recombinantly engineered TB vaccine antigen in which immunodominant antigens (Ag85B and TB10.4) secreted by Mycobacterium Tuberculosis are combined to provide highly efficient and immunogenic fusion molecules. HyVac4 is closely related to the Hybrid1 (H1) TB vaccine antigen which earlier this year successfully completed a phase I clinical trial in Leiden also in combination with IC31® and for which further clinical trials are in preparation.

https://www.bionity.com/en/news/75448/statens-serum-institut-intercell-and-aeras-announce-the-initiation-of-a-clinical-trial-for-a-novel-tb-vaccine-candidate.html