OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Completed

• Conditions: Gonorrhea

• Registration Number: NCT05613725
• Lead Sponsor: University of Oxford

Brief 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Study Start: 2022-12-02
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Adults (18-50 years) attending Oxford University Hospitals NHS Foundation Trust with untreated confirmed N. gonorrhoea infection confirmed by either:

  • Nucleic acid test
  • Microscopy of urethral discharge

Exclusion Criteria

• Have already received antimicrobial therapy to treat the N. gonorrhoea infection
• Have not provided written, informed consent.
• Presence of any known medical condition which, in the opinion of the local investigator, makes the donation of 26 mls of blood unsafe.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular immune response	Blood sampling at enrolment	Cellular immune response detected by ELISpot +/- Flow cytometry from PBMCs collected from the blood of patients presenting with confirmed N.gonorrhoea infection.

Trial Locations

Locations (1)

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom