Pilot Study of the Immunogenicity, Reactogenicity and Tolerability of Two Schedules of a 4CmenB Vaccine in Adolescents and Young Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Serogroup B
• Intervention / Treatment: Biological: Bexsero®; Biological: Havrix®

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • IWK Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Accelerated Schedule	Biological: Bexsero®; Multicomponent meningococcal B vaccine; Biological: Havrix®; Hepatitis A vaccine
Active Comparator: Group 2: Standard Schedule	Biological: Bexsero®; Multicomponent meningococcal B vaccine; Biological: Havrix®; Hepatitis A vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA	Immune responses will be measured: Prior to 4CMenB vaccine (baseline); To a single dose of 4CMenB vaccine 21 days post-immunization; 21 days after the second dose of an accelerated compared to a standard 4CMenB schedule; Six months after an accelerated 4CMenB vaccine schedule and a standard schedule	Baseline to day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of solicited general adverse events	The number of participants in each vaccine group with each symptom day 0 to 6 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.) The following general AEs will be solicited: Drowsiness; Fever; Nausea; Diarrhea; Vomiting; Generalized muscle aches	Day 0-6
Number of unsolicited general adverse events	The number of participants in each vaccine group with each symptom day 0 to 21 after vaccine will be summarized. Each vaccine participant will record if they had any symptoms (yes/no) and the severity (mild, moderate, or severe.)	Day 0-21
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		From injection to Day 180
Number of solicited local and systemic injections site reactions	The following local (injection-site) AEs will be solicited: Pain at injection site; Redness at injection site; Swelling at injection site	Day 0-6

Collaborators and Investigators

• Sponsor: Canadian Immunization Research Network
• Collaborators: University of British Columbia; University of Calgary; Dalhousie University; Université de Montréal
• Investigators: Principal Investigator: Joanne M Langley, MD, MSc, FRCPC, IWK Health Centre, Dalhousie University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CT11