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

NCT02583412 | Completed Phase 4 DMC

• 1 other identifier: CT11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningococcal Serogroup B

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of solicited general adverse events

  Day 0-6

• Number of unsolicited general adverse events

  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

  Day 0-6

Study Arms (2)

Group 1: Accelerated Schedule

ACTIVE COMPARATOR

Biological: Bexsero®; Biological: Havrix®

Group 2: Standard Schedule

ACTIVE COMPARATOR

Biological: Bexsero®; Biological: Havrix®

Interventions

Bexsero® BIOLOGICAL

Multicomponent meningococcal B vaccine

Group 1: Accelerated Schedule; Group 2: Standard Schedule

Havrix® BIOLOGICAL

Hepatitis A vaccine

Group 1: Accelerated Schedule; Group 2: Standard Schedule

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Immunization Research Network: lead
• University of British Columbia: collaborator
• University of Calgary: collaborator
• Université de Montréal: collaborator
• Dalhousie University: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31270173 DERIVED

MeSH Terms

Interventions

4CMenB vaccine; Hepatitis A Vaccines

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Joanne M Langley, MD, MSc, FRCPC

  IWK Health Centre, Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: October 22, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 30, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CA (1)