Clinical trial of chlamydia vaccine CTH522 in healthy men and women
Research type
Research Study
Full title
A phase I, double-blind, parallel, randomised and placebo-controlled trial investigating the safety and immunogenicity of a chlamydia vaccine, CTH522, in healthy adults
IRAS ID
266508
Contact name
Peter Bang
Contact email
Sponsor organisation
Statens Serum Institute
Eudract number
2019-001090-88
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 20 days
Research summary
Chlamydia is an infection caused by bacteria passed from one person to another through unprotected sex, and is particularly common in teenagers and young adults. If left untreated the infection can cause long-term health problems, such as women not being able to have babies. Worldwide there are about 131 million new chlamydia infections each year.
The same chlamydia bacteria cause eye infection ('trachoma') in some of the poorest parts of the world. The infection
is transmitted by transfer of eye discharges and snot of infected people, particularly young children. It can be spread by
some types of flies. Trachoma causes problems with eyesight, including blindness, in about 1.9 million people.A vaccine is a medicine that prevents infection. There is currently no vaccine against chlamydia. Vaccines are usually given as an injection into the upper arm.
We are testing a new chlamydia vaccine, referred to as 'CTH522', in healthy men and women. CTH522 is a copy of the surface of chlamydia bacteria. When we give CTH522 to people, we hope their body's immune system will use it to make defences which will prevent chlamydia infection.
The CTH522 will be mixed with substances, called 'adjuvants', which are there to further stimulate the immune system.
We will give the vaccine as an injection into the upper arm, and as eye drops.
We don’t know yet whether CTH522 will work, or what its side effects will be. The main aim of the study is to assess the safety of the vaccine, but we'll also assess its effects on the immune system.
The study will be quite small – only 66 healthy men and women, who will attend 12 visits at the Hammersmith Hospital in London, over a period of about 40 weeks. They will be paid for their time and to cover travel expenses.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0353
Date of REC Opinion
19 Jul 2019
REC opinion
Favourable Opinion