Safety and effects of FP-02.2 - first doses in humans;v1

• Research type

  Research Study

• Full title

  A phase 1, randomised, double-blind, placebo-controlled, multi-centre, ascending-dose trial to evaluate the safety, tolerability and immunogenicity of Vaccine FP-02.2 in HBeAg-negative hepatitis B patients as an add-on treatment to entecavir or tenofovir. HMR code: 15-501

• IRAS ID

  179335

• Contact name

  Mark Thursz

• Contact email

  m.thursz@imperial.ac.uk

• Sponsor organisation

  Vaxin UK Ltd

• Eudract number

  2015-000880-15

• Duration of Study in the UK

  1 years, 8 months, 3 days

• Research summary

  FP-02.2 is an experimental vaccine for treating chronic hepatitis B (CHB). Hepatitis B is a viral infection that affects the liver. The white blood cells of patients with CHB don’t work very well in fighting the infection. There are existing medicines for treating CHB that stop the virus multiplying, but don’t rid the body of the virus. We hope that FP-02.2 will work by stimulating the white blood cells to rid the body of the virus after only a few doses.

  We’ll aim to find out whether FP-02.2 has any side effects, how it affects the immune system, and whether it can reduce hepatitis B virus levels. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose once we’ve checked the low dose is safe. We’ll either give FP-02.2 alone or with an adjuvant (a substance that helps the vaccine stimulate the white blood cells). We’ll also study how genes (pieces of DNA) affect the way the body responds to FP-02.2.

  We’ll recruit 72 patients with CHB, aged 18–65 years, who are taking an existing medicine that stops the hepatitis B virus multiplying. We’ll give the participants 3 doses of FP-02.2 or a control vaccine, about 1 month apart. Participants will take at least 10½ months to finish the study. They’ll make at least 17 outpatient visits:
  * 2 screening visits
  * at least 2 pre dosing visits, about 1 month apart
  * 3 dosing visits about 1 month apart, each followed by up to 3 post-dose visits
  * 2 follow-up visits up to 5½ months after the last dose.

  A pharmaceutical company (Vaxin UK Ltd) is funding the study.

  At least 6 NHS centres in the UK will conduct the study.

• REC name

  London - Central Research Ethics Committee

• REC reference

  15/LO/0743

• Date of REC Opinion

  19 May 2015

• REC opinion

  Further Information Favourable Opinion