nravelling the protective effects of the MeNZB™ vaccine against gonorrhoea.

Not Applicable

• Conditions: Meningococcal Disease; Gonorrhoea; Infection - Other infectious diseases; Infection - Sexually transmitted infections

• Registration Number: ACTRN12622001452785
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-14
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Persons born between 01 January 1984 and 01 January 2004.
•Persons over the age of 18 years, deemed competent and capable to consent and willing and able to participate throughout the whole study
•For females of reproductive potential: use of highly effective contraception during study participation
•Provision of signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study
•Have a NHI number and be willing to provide access to their NIR records
•If born or has received a vaccine overseas, be willing to give us access to their vaccination records from the country of vaccination.

Exclusion Criteria

•Have a previous history of vaccination for meningococcal B with 4CMenB.
•Those who have already received an NMB OMV vaccine, other than the MeNZB™ vaccine.
•Those who have received a dose of any NM OMV vaccine after the end of the MeNZB period (2008).
•Have contraindications to receiving the meningococcal B vaccine which include:
oPrevious anaphylactic reaction following a previous dose of any meningococcal vaccine.
oPrevious anaphylactic reaction following any vaccine component.
oImmunological condition preventing participant receiving vaccination.
oOther medical condition preventing participant receiving vaccination.
•Are participating in biomedical prevention strategies for bacterial STIs.
•Are taking complement inhibitors such as eculizumab or ravulizumab.
•Have an immunological disorder; such as those with severe autoimmune disorders, AIDS patients or those undergoing immunotherapy, including chemotherapy for blood or white blood cell cancers and organ transplant recipients.
•Have any major unstable medical condition or therapy that may cause immune compromise (e.g. chemotherapy, radiation, corticosteroids [prednisone >5mg/day] within 14 days prior to screening).
•Females who are pregnant or are planning to become pregnant during the course of the investigation.
•Persons unable or unwilling to comply with study requirements for participants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified