NCT05613725

OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Optimising Laboratory Assays for Immune Responses to Gonococcus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study. Blood from otherwise healthy patients presenting with confirmed N.gonorrhoea infection, prior to treatment, will be collected to (i) allow the optimisation of assays assessing the immune response to gonococcus and (ii) assess whether N. gonorrhea specific responses can be detected on ELIspot +/- flow cytometry. The investigators plan to recruit up to 30 adults (men and women, aged 18-50 years) who have been diagnosed with confirmed N.gonorrhoea infection at the Sexual Health Clinic at the Oxford University Hospitals NHS Foundation Trust. The investigators will collect blood samples from consenting participants prior to them receiving curative antibiotic treatment.

Detailed description

On the day the patient attends the Sexual Health Clinic, they will be given the PIS to consider participation to the study following a confirmed positive result for N. gonorrhoea infection. Following written informed consent, a venous blood sample will be collected (up to 26 ml) on the same day. This will conclude that participant's involvement to the study. The blood sample will be transported to the laboratory at the Jenner Institute, University of Oxford for further analysis.

Conditions

• Gonorrhea

Interventions

Type	Name	Description
OTHER	Blood sample collection	Blood sample collection

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-11-14
• Last updated: 2024-05-21

Locations

1 site across 1 country: United Kingdom