All volunteers have now received three doses of 2AP01 (AAVLP-HPV), our very broad spectrum HPV vaccine formulated without adjuvant. The vaccine is well tolerated and no serious adverse events (SAEs) have been observed to date.
The first-in-human, phase 1, randomised, placebo-controlled, double-blind study is designed to assess the safety and tolerability and to explore the immunological effects of intramuscularly administered 2AP01 vaccine in healthy adult male and female volunteers between the ages of 18 and 45. The trial is being conducted by Celerion in Belfast, Northern Ireland under a Clinical Trial Authorisation issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
About 2A Pharma’s HPV vaccine candidate (2AP01)
2AP01 is a human papillomavirus (HPV) vaccine based on 2A Pharma’s proprietary adeno-associated virus-like particle (AAVLP) platform and targets the HPV L2 protein.
The HPV genome is packaged inside a capsid consisting of the L1 major protein and the L2 minor protein. All existing approved vaccines target the L1 protein which varies significantly between HPV types. In existing HPV L1 vaccines, different particles must be produced for each HPV type and then mixed in the final product, increasing production complexity and cost.
The L2 capsid protein, targeted by 2A Pharma’s HPV vaccine, is well conserved across HPV types which means our vaccine candidate provides protection for a wide range of HPV types with just one AAVLP particle type. The result is a potentially superior product with broader protection and lower production cost.