A Phase 1, Study of CoVaccine HT™ in Healthy Adult Volunteers

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT in Healthy Adult Volunteers

• IRAS ID

  36024

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Protherics Medicines Development Limited, a subsidiary of BTG PLC

• Eudract number

  2009-016063-11

• Research summary

  CoVaccine HT is an adjuvant (an agent that modifies the effect of other drugs) developed by Protherics which can be used in vaccines to improve their effectiveness. In a recent study sponsored by Protherics a vaccine to treat high blood pressure that contained CoVaccine HT was given to 20 patients with mild to moderate high blood pressure. Safety data from that study revealed that the adverse reactions to the vaccine injections were more severe and lasted longer than was considered acceptable in a vaccine for high blood pressure. The probable cause of these adverse events was the dose of CoVaccine HT (20 mg) administered. In the future Protherics would like to start another study in people with high blood pressure but with a different CoVaccine HT dose. The purpose of this study is to investigate the safety and tolerability of selected doses of CoVaccine HT between 2 and 20 mg to help identify an appropriate dose that can be used in another study in people with high blood pressure. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Up to 60 healthy volunteers in 5 groups of 10 will participate in the trial. Each volunteer will attend the unit for a series of three intramuscular injections, each separated by 21 days.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/95

• Date of REC Opinion

  3 Nov 2009

• REC opinion

  Favourable Opinion