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OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

Optimising Laboratory Assays for Immune Responses to Gonococcus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05613725
Enrollment
18
Registered
2022-11-14
Start date
2022-12-02
Completion date
2024-04-30
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonorrhea

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.

Interventions

OTHERBlood sample collection

Blood sample collection

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cellular immune responseBlood sampling at enrolmentCellular immune response detected by ELISpot +/- Flow cytometry from PBMCs collected from the blood of patients presenting with confirmed N.gonorrhoea infection.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026