None listed
Conditions
Brief summary
This study is a prospective observational cohort study in males and females, investigating the immune response in people vaccinated with the Neisseria meningitidis serogroup B (MenB) vaccine 4CMenB. Participants will receive 2 doses of 4CMenB vaccine 2 months apart by intramuscular injection. Gonorrhoea-specific immune responses will be measured to characterise possible mechanisms of vaccine-induced protection against gonorrhoea and to identify immunodominant antigens in 4CMenB and potential future gonorrhoea vaccine-candidates.
Interventions
Administration of 0.5mL 4CMenB vaccine intramuscularly at baseline and 2 months. A pre-vaccination checklist will be used to ensure safe administration of vaccine. Administration of vaccine including batch and expiry dates and recording immediate adverse events will be recorded in the participant's clinical electronic record and in the electronic case report form. Optional consent will be sought to record administration of vaccine in the Australian Immunisation Register.
Sponsors
Griffith University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Outcome results
None listed