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

Phase 4

Completed

• Conditions: Meningococcal Serogroup B
• Interventions: Biological: Bexsero®; Biological: Havrix®

• Registration Number: NCT02583412
• Lead Sponsor: Canadian Immunization Research Network

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2016-09
• Study Completion: 2017-06-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Standard Schedule	Havrix®	-
Group 1: Accelerated Schedule	Havrix®	-
Group 2: Standard Schedule	Bexsero®	-
Group 1: Accelerated Schedule	Bexsero®	-

Primary Outcome Measures

Name	Time	Method
Immune responses to 4CMenB vaccine, as measured by human Serum Bactericidal Assay (hSBA	Baseline to day 180	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

Secondary Outcome Measures

Name	Time	Method
Number of solicited general adverse events	Day 0-6	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
Number of unsolicited general adverse events	Day 0-21	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.)
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	Day 0-6	The following local (injection-site) AEs will be solicited: * Pain at injection site; * Redness at injection site; * Swelling at injection site

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada