Clinical trial NCT02583412: Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults
Official title: Preparedness for and Response to Meningococcal Outbreaks: a Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Serogroup B
Lead sponsor: Canadian Immunization Research Network
Sponsor class: NETWORK
Collaborators: name: University of British Columbia
name: University of Calgary
name: Université de Montréal
name: Dalhousie University
First posted: 2015-10-22
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall aim of this study is to determine if an accelerated "Bexsero® (Multicomponent meningococcal B vaccine)" schedule compared to a standard schedule is immunogenic, safe, and tolerable, in order to increase capacity for rapid outbreak control. In this pilot study no formal hypothesis is tested.

Detailed description: A pilot study to evaluate the feasibility of a rapid clinical trial at the time of a meningococcal B outbreak, comparing an accelerated schedule of 4CMen B (0, 3 weeks) to the 0, 2 months schedule, to determine if the more compressed schedule is immunogenic, safe and tolerable. A shorter schedule offers the potential benefit of more rapid direct and indirect protection, and use of fewer public health resources for implementation.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 17 to 25 years.
* Current or intended student at an educational setting in the 2015-2016 year.
* Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

* Significant renal or hepatic impairment.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
* Previous bacteriologically confirmed N. meningitidis disease.
* Prior receipt of a meningococcal B vaccine
* Hypersensitivity to any vaccine component of products used in this study (see product monographs)
* Immunodeficiency or autoimmune disease

Primary outcomes:
measure: Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA
timeFrame: Baseline to day 180
Secondary outcomes:
measure: Number of solicited general adverse events
timeFrame: Day 0-6
measure: Number of unsolicited general adverse events
timeFrame: Day 0-21
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 reported in the accelerated vaccine schedule compared to a standard schedule
timeFrame: From injection to Day 180
measure: Number of solicited local and systemic injections site reactions
timeFrame: Day 0-6
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre, Dalhousie University
name: Joanne M Langley, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharkey K, Beernink PT, Langley JM, Gantt S, Quach C, Dold C, Liu Q, Galvan M, Granoff DM. Anti-Factor H Antibody Reactivity in Young Adults Vaccinated with a Meningococcal Serogroup B Vaccine Containing Factor H Binding Protein. mSphere. 2019 Jul 3;4(4):e00393-19. doi: 10.1128/mSphere.00393-19.