OptiGon
Research type
Research Study
Full title
Optimising Laboratory Assays for Immune Responses to Gonococcus
IRAS ID
317813
Contact name
Calman MacLennan
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Gonorrhoea is a sexually transmitted disease caused by the bacteria Neisseria Gonorrhoeae. Individuals commonly present with urethritis and cervicitis which can progress to ascending infection with pelvic inflammatory disease, ectopic pregnancy and infertility, disproportionally affecting women in low and middle income countries. There are more than 80 million cases annually worldwide and gonorrhoea is one of three most urgent global threats identified by the O'Neill report on Antimicrobial Resistance1. There is therefore an overwhelming need to develop a vaccine against gonococcus as an urgent global public health priority. Vaccine development to date has been hampered by our limited understanding of the human immune response to gonorrhoea.
We seek to set up a programme of work examining the human immune response to primary and secondary gonococcal infection using (i) the established controlled human infection model14 and (ii) samples from a proposed large, prospective clinical cohort study. Both of these avenues of work will include analysis of human serum and peripheral blood mononuclear cells (PBMCs) from patients with gonococcal infection. To facilitate successful funding applications for this work, we need to optimise proposed antibody and cellular assays assessing the human immune response and provide preliminary data showing that urogenital infection with N. gonorrhoea does result in detectable cellular responses. In this study we aim to collect samples from healthy patients presenting with urogenital N. gonorrhoea infection, prior to treatment, in order to (i) optimise serum and cellular assays and (ii) demonstrate that cellular responses can be detected.
REC name
London - Surrey Research Ethics Committee
REC reference
22/PR/1233
Date of REC Opinion
18 Oct 2022
REC opinion
Further Information Favourable Opinion