2A Pharma has received approval from the UK Medicines and Healthcare products Regulatory Authority and from the local Ethics Committee to proceed with a first-in-human study of 2AP01, which is being developed as broad coverage prophylactic HPV vaccine formulated without adjuvants. 2A Pharma expects that screening of volunteers will commence in January 2019 with first dosing in March 2019 and completion of the study in March 2020.
The study is a first-in-human, phase 1, randomised, placebo-controlled, double-blind study to assess the safety and tolerability, and to explore immunological effects of intramuscularly administered AAVLP-HPV vaccine in healthy adult male and female volunteers.