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Oxford University Hospitals NHS Foundation Trust

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Clinical trial to evaluate a new Hepatitis B vaccine

Trial categories: Blood; Cancer; Immunity; Infection; Vaccines

Sponsoring organisation: Oxford Vaccine Group and VBI Vaccines

A Double-blind Randomized Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)

Aged 18-45? You could join our hepatitis vaccine study and help us beat Hepatitis B together.

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
  • 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.

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

All participants will be reimbursed for their time, travel and the inconvenience of taking part.

Confidentiality

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

If you are interested in taking part please clink 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

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