Immune responses to KLH, Tetanus toxoid, Shingrix and Zostavax
Research type
Research Study
Full title
An exploratory study to characterise the immune responses to keyhole limpet hemocyanin, tetanus toxoid, and varicella zoster vaccine in healthy subjects
IRAS ID
258065
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Kiniksa Pharmaceuticals Ltd c/o Kiniksa Pharmaceuticals Corp.
Eudract number
2000-123456-78
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is an exploratory study to measure the immune response of healthy people to test substances (‘antigens’) and to compare the responses to each of these 4 different test antigens in different groups of people:
1. keyhole limpet haemocyanin (KLH) – a purified protein from shellfish;
2. tetanus toxoid (TT) vaccine – an inactivated form of the toxin that causes tetanus;
3. Shingrix, the vaccine against varicella-zoster virus – the virus that causes chickenpox;
4. Zostavax, another vaccine against varicella-zoster virus.We’ll also investigate how the immune response to each antigen varies between people. We’ll use the results to better understand how the immune system works, how it varies between people and how to design new ways of measuring it. That will help with the design of future studies of new medicines.
40 healthy volunteers, aged 18–50 years, will receive a single dose of 1 of these 4 antigens, given by injection in the arm, at each of two separate visits, 4 weeks apart. Volunteers will be split into 5 groups of up to 8 volunteers and receive antigen injections as follows:
• 1 group will receive KLH
• 2 groups will receive TT
• 1 group will receive Shingrix and
• 1 group will receive Zostavax
Participants will take up to 12 weeks to finish the study and will have outpatient visits every week. Participants will make up to 10 outpatient visits, including at least 1 screening visit, and 1 follow-up visit.A pharmaceutical company (Kiniksa, Ltd.) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
19/NI/0008
Date of REC Opinion
5 Feb 2019
REC opinion
Favourable Opinion