Clinical trial of chlamydia vaccine CTH522 in healthy women; v1
Research type
Research Study
Full title
A phase I first in human, double-blind, parallel, randomised and placebo controlled clinical trial of the safety of SSI’s adjuvanted chlamydia vaccine CTH522 in healthy women aged 18 to 45 years
IRAS ID
195242
Contact name
Tom Cole
Contact email
Sponsor organisation
Statens Serum Institut
Eudract number
2015-004330-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
In spite of the availability of effective antimicrobial Chlamydia therapy, infection with Chlamydia trachomatis (C. trachomatis) is a public health concern because of its prevalence and potentially devastating reproductive consequences. \nStatens Serum Institut has developed a molecular designed novel multivalent vaccine antigen (CTH522). It is a recombinant version of the major outer membrane molecule (MOMP) from C. trachomatis, designed to induce broadly neutralizing antibodies.\nThe present trial is a phase I first in human, double blind, parallel, randomised, and placebo controlled trial of SSI’s adjuvanted chlamydia vaccine CTH522 (CTH522-CAF01 and CTH522-Al(OH)3). The trial will be conducted at NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, London, UK.\nSubjects are randomly assigned to one of the following three treatment groups in a ratio of 3:3:1:\n•\tCTH522-CAF01 \n•\tCTH522-Al(OH)3\n•\tPlacebo\nWe don’t know yet whether it 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 35 healthy women will participate.\n
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/0717
Date of REC Opinion
19 May 2016
REC opinion
Favourable Opinion