Clinical trial to evaluate a new Hepatitis B vaccine (CONSTANT study)
Research type
Research Study
Full title
A Double-blind Randomised Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults (CONSTANT)
IRAS ID
233850
Contact name
Mira-Bianca Stanescu
Contact email
Sponsor organisation
VBI Vaccines INC.
Eudract number
2017-001820-22
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Hepatitis B is a serious disease caused by a virus known as HBV. When exposed to HBV, it can “infect”, or get into people’s blood where it travels to the liver and enters the cells. Once inside, the virus multiplies and attacks the liver cells causing hepatitis B. The liver can be severely damaged by hepatitis B. People with this disease often develop other liver diseases such as cirrhosis or liver cancer. Hepatitis B can also lead to liver failure and death.
There are limited effective treatments for hepatitis B. A way to protect people from getting this disease is by a vaccine that targets HBV to make it unable to enter the liver. Vaccines are designed to defend against a particular virus by boosting the ability of the body’s immune system defences against that virus.
In this study, the immune system response to the study vaccine will be compared between three lots of the vaccine and with the immune response after a standard vaccine (Engerix B®), which is approved for use in the US, Canada, and the EU. Any side effects reported after administration of the study vaccine will also be compared with those reported after Engerix B®.
The study vaccine is an “investigational” vaccine, the regulatory authorities, does not yet approve for use in the UK, US, Canada, and the EU. It has been approved for use in other countries, including Israel.
When injected in the muscle, the vaccine will teach the immune system how to recognise the HBV and destroy it. The injection must be repeated 1 month and 6 months later for better results. If the vaccination is successful, the level of special proteins in the blood (antibodies) that are created by the immune system to recognise HBV will increase in the blood. The person will then likely be protected against HBV. Protection is thought to be long lasting.
Approximately 3200 participants at up to 40 study hospitals throughout the United States, Canada, and the EU will be included.
This study is being funded by VBI Vaccines Inc.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0015
Date of REC Opinion
20 Feb 2018
REC opinion
Further Information Favourable Opinion