Recruiting now for clinical trial to evaluate a new Hepatitis B Vaccine (CONSTANT Study)

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You are invited to take part in a study to investigate a new Hepatitis B vaccine. The study is being run by the Oxford Vaccine Group which is part of the University of Oxford.

What is this study about?

Hepatitis B is a serious infection of the liver caused by a virus (HBV) that is spread through blood and other body fluids. Hepatitis B affects millions of people worldwide. Long term (chronic) infection with HBV can lead to liver failure, cancer and death.

Treatment options for chronic HBV infection are limited therefore a better option is to reduce your risk of HBV infection by vaccination.

This study is comparing a new Hepatitis B vaccine, currently unlicensed in the UK, with a Hepatitis B vaccine that is currently available in the UK.

What is involved?

We aim to enrol up to 85 adults aged between 18 and 45 who have not previously been vaccinated against Hepatitis B.

We wish to recruit adults who:

  • are in good health
  • have NOT previously been vaccinated against HBV
  • are not pregnant, planning to become pregnant or breastfeeding during the study
  • (women only) willing to use effective birth control for the duration of the study

Confidentiality

All information about you and your involvement in the study which could be used to identify you would be kept strictly confidential.

Study duration

The study will last for approximately 1 year and will involve a screening visit, 5 study visits and 4 telephone check-ups. Participants will receive 3 doses of vaccine over the course of the study and will be asked to provide blood samples on 5 occasions. The vaccine you are given will be decided at random by a computer. The study is double blinded, meaning that neither study staff nor participants will know which vaccine has been received until the end of the study.

Reimbursement

You will receive £50 per completed visit to compensate you for your time and inconvenience. Reasonable travel expenses associated with taking part in this study, for example to attend visits, will be reimbursed.

(CONSTANT Participant Information Booklet V1.1 05-Feb-2018)

Organisation

Oxford Vaccine Group, Department of Paediatrics, University of Oxford

Contact

If you would like more information please click on the link below:

http://trials.ovg.ox.ac.uk/trials/constant

Alternatively, you can call us on 01865 611400 or email us at info@ovg.ox.ac.uk

Clinical Trial Registration Details

Study trial: A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot
Consistency of Sci-B-Vac™ in Adults
Study number: Sci-B-Vac–002
NCT number: NCT03408730
EudraCT Number: 2017-001820-22
IRAS Project ID: 233850
REC Reference: 18/NW/0015 (North West Greater Manchester)