None listed
Conditions
Brief summary
We will explore the immunogenic nature of the MeNZB™ vaccine through conducting a two armed exploratory trial, comparing the immune response of primed participants (whom have received the MeNZB vaccine in the past) with that of naïve participants (those whom have not received the MeNZB vaccine previously). Participants will receive 2 doses of Bexsero (a new generation meningococcal group B vaccine that includes the MeNZB antigen) administered intramuscularly, with a minimum of 30 days between doses to allow for complete adaptive immune response to the meningococcal antigen. Blood and mucosal samples will be collected throughout the course of the trial and analysed in specified laboratory assessments in batch runs. Through examining blood and mucosal samples from study participants we aim to identify the mechanisms responsible for cross-protection against gonorrhoea seen with the MeNZB vaccine, as well as evaluating meningococcal group B immunity after a single boost a decade after priming. We hypothesise that vaccination with the meningococcal group B OMV vaccine, MeNZB™, alters the cellular immune response to both meningococcal and gonococcal antigens; and that these responses will be significantly enhanced in individuals who received this vaccine in childhood.
Interventions
The intervention group in this study are immunologically primed individuals (those who meet the inclusion criteria and have received two doses of MeNZB in the past). Both intervention and control groups will receive the same intervention.
The intervention administered is a primary course of Bexsero® (Multicomponent Meningococcal group B Vaccine), administered as two doses.
The dose administered is 0.5 mL of vaccine.
The duration of administration is a minimum of 30 days and maximum of 37 da
The intervention group in this study are immunologically primed individuals (those who meet the inclusion criteria and have received two doses of MeNZB in the past). Both intervention and control groups will receive the same intervention. The intervention administered is a primary course of Bexsero® (Multicomponent Meningococcal group B Vaccine), administered as two doses. The dose administered is 0.5 mL of vaccine. The duration of administration is a minimum of 30 days and maximum of 37 days between doses. The mode of administration is via intramuscular injection, performed by a licensed vaccinator. Intervention adherence will be monitored through REDCap, research data capture software utilised in this study for participant enrolment and scheduling. The intervention will be administered within the clinical trial space at the University of Auckland.
Sponsors
The University of Auckland
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 40 Years
Healthy volunteers
Yes
Inclusion criteria
• Persons born between 01 January 1984 and 01 January 2006. • Persons over the age of 18 years at the time of enrolment into the study, 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: o Previous anaphylactic reaction following a previous dose of any meningococcal vaccine. o Previous anaphylactic reaction following any vaccine component. o Immunological condition preventing participant receiving vaccination. o Other 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.
Outcome results
None listed