SIS4V study
Research type
Research Study
Full title
Safety and Immunogenicity of a Shigella tetravalent bioconjugate vaccine in adults
IRAS ID
1007321
Contact name
Maheshi Ramasamy
Contact email
Sponsor organisation
LimmaTech Biologics AG
Eudract number
2023-000129-10
Research summary
Shigella is a group of bacteria that causes food poisoning throughout the world. Shigella bacteria are transmitted through contaminated food or water supplies or from person to person through direct contact via unclean hands or surfaces. Shigella bacteria cause around 200,000 deaths per year.
In this study we are investigating a new vaccine against Shigella called the Shigella4V vaccine. This vaccine has been developed by a Swiss pharmaceutical company LimmaTech Biologics AG, with which the Oxford Vaccine Group is collaborating on this study.
The vaccine does not contain Shigella bacteria and therefore cannot cause infection or disease.
The study is being conducted to evaluate the safety of the vaccine and how well it stimulates the immune system against Shigella bacteria, and to establish an International Standard for anti-Shigella serum. The study will be conducted at OVG and is funded by the Bill & Melinda Gates Foundation.
The study will recruit healthy adults aged 18 to 55 years old who will first have a screening visit to confirm suitability for the trial. On enrolment, participants will be enrolled into 1 of 2 groups to receive either the half dose or full dose of the vaccine.
Each participant would receive 1 vaccination with the Shigella4V vaccine. In addition, each participant would require blood tests immediately before each vaccination and at specific intervals after each vaccination. The study will require a total of 4 visits over a 6-month period (vaccination visit, 1 week, 1 month and 6 months after vaccination). The larger blood sample (400ml) will be taken at the 1 month visit. This blood sample will be used to to create a reference standard to develop laboratory tests and compare how well this vaccine or future vaccines are working.
Participants will record any symptoms or side effects and daily temperatures for the next 7 days following vaccination. The results of the research will be published and will appear on the OVG website.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0130
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion