OptiGon - Optimising Laboratory Assays for Immune Responses to Gonococcus

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.

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Key information

Conditions

Gonorrhea Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sample Collection

Other

Blood sample collection

Primary outcomes

Cellular immune response

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Optimising Laboratory Assays for Immune Responses to Gonococcus

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Nov 14, 2022
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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