VIRGo – Vaccine-induced Immune Responses against Gonorrhoea: A study to investigate immune response induced by the 4CMenB vaccine against gonorrhoea

Phase 2

Conditions: gonorrhoea
Infection - Sexually transmitted infections
Inflammatory and Immune System - Normal development and function of the immune system

Registration Number: ACTRN12623000738628

Lead Sponsor: Gold Coast University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

i.Are between 18 to 50 years of age
ii.Are able to understand spoken and written English
iii.Are able to participate in study procedures including attending for all study visits
iv.Agree to be contacted via phone/ email by the study team
v.Have sexual partners of the opposite sex only

Exclusion Criteria

i.Documented allergy to latex and/ or kanamycin
ii.Confirmed previous history of vaccination for Meningococcal B with 4CMenB vaccine)
iii.Contraindications to receiving the Meningococcal B vaccine which include:
a)Anaphylaxis following a previous dose of any meningococcal vaccine
b)Anaphylaxis following any vaccine component
iv.Pregnant or intending to become within the next 3 months
v.Currently breast-feeding
vi.Received a COVID vaccine within the last 7 days
vii.Patients who are currently recommended and funded to received 4CMenB vaccine including:
a)Sickle cell disease or other haemoglobinopathies
b)Congenital or acquired asplenia (e.g. Splenectomy or hyposplenia)
c)Defects in, or deficiency of, complement components including factor H, factor D or properdin deficiency
d)Current or future treatment with eculizumab (a monoclonal antibody directed against complement component C5)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody killing of N. gonorrhoeae measured by serum bactericidal activity (SBA) assays[ 3 and 6 months from baseline];Antibody function blocking activity measured as percentage inhibition of adherence to, and invasion of N. gonorrhoeae to epithelial cells, assessed as a composite outcome[ 3 and 6 months from baseline];Antibody killing of N. gonorrhoeae measured by serum opsonophagocytic (OPA) assays[ 3 and 6 months from baseline]

Secondary Outcome Measures

Name	Time	Method
Antibody levels (measured in titres) against whole cell N. gonorrhoeae, outer membrane vesicles (OMV), and Neisserial Heparin Binding Antigen (NHBA) measured by Enzyme Linked Immunosorbent Assays (ELISA) pre- and post- vaccination, assessed as a composite outcome[ 3 and 6 months from baseline (1 and 4 months from completion of vaccine course)];Antigen-specific memory B cells and T-cell responses measured by flow cytometry, ELISPOT and cytokine assays, assesssed as a composite outcome<br>[ 3 and 6 months from baseline]