Asphalion and HIVACAR consortium members attended a scientific and technical advice type III meeting with the Belgian regulatory authorities AFMPS/FAGG. The aim of the meeting was to support the planned clinical trial application (CTA) for the proposed Phase I/II study, to present and discuss CMC, non-clinical and clinical issues, especially those related to the novel vaccine products and the combination strategy.
Given the complexity of the project and the novelty of some of the vaccine components, the scientific discussion was extremely rewarding for both sides and HIVACAR is very grateful for the detailed and insightful input from AFMPS/FAGG. The outcome of the meeting was very positive and paved the way for the imminent CTA which will be submitted in Q4 2017 with the trial due to start in Q2 2018. Asphalion will also be closely involved in the submission process and the preparation and review of the documentation.
HIVACAR is an EC funded consortium and project funded under the EC Framework Programme for Research, Innovation and Technology Horizon 2020 call H2020 SC1-PM-09-2016, New therapies for chronic diseases of which Asphalion is a partner.
If you are interested and wish to have further information about HIVACAR project or Horizon 2020 program please contact us at H2020@asphalion.com