1346. Preparedness for and Response to Meningococcal Outbreaks:Safety Results of a Randomized Controlled Trial of Two Schedules of 4CMenB Vaccine in Adolescents and Young Adults
Session: Poster Abstract Session: Clinical Trials
Friday, October 28, 2016
Room: Poster Hall
Posters
  • ihd IDWeek 4CMenBSafety poster v17Oct 2016 V2.pdf (3.0 MB)
  • Background:

    Emergency vaccination programs are often needed when outbreaks of Meningococcal B (MenB) disease in young adults attending university occur. The four component MenB vaccine (4CMenB, Bexsero, Novartis, GlaxoSmithKline) is authorized for persons 2 months through 17 years in Canada, but there is limited data on safety and immunogenicity in persons >17 years or on various dosing schedules.

    Methods:

    A randomized, controlled, observer-blinded trial comparing an accelerated 4CMenB schedule (0, 21 days) compared to a standard schedule (0, 60 days) was conducted during the academic year (Sept 2015-April 2016) in persons 17-25 years of age, in stable health and attending school, at three sites. The first dose in both groups was 4CMenB vaccine. Solicited local and systemic adverse events (AE) days 0-6 post vaccine and unsolicited events days 0-21 were collected on memory aides. Analysis of immune responses on Days 0, 21, 42, 81 and 180 is underway.

    Results:

    Among 121 participants the mean age was 21.4 years (range 17.0, 26.0); 69.4% (n=84) were female. Any solicited AE occurred in 100%, 73.7 and 78.0% post doses 1, 2 and 3 respectively. One serious AE (fractured patella) occurred. The most common solicited AE Day 0-6 was local: pain at the injection site in 99.2%, 64.4% and 71.2% after doses 1, 2 and 3 respectively, followed by systemic muscles aches in 52.9%, 33.1%, and 35.6% respectively. Drowsiness Day 0-6 occurred in in 38%, 27.1%, and 29.7% and nausea in 18.2%, 17.8% and 16.9% of participants after doses 1, 2 and 3 respectively. Fever was only reported in 2 participants (1.7%), after dose 2. Overall, a Grade 1 AE occurred in 33.9%, 32.2% and 30.5%, any Grade 2 AE in 30.6%, 11.9% and 13.6%, and a Grade 3 AE in 5.8%, 5.9% and 6.8% of participants after doses 1, 2 and 3.

    Conclusion:

    A multicenter rapid clinical trial of a 4CMenB vaccine, was conducted by the Clinical Trials Network of CIRN. Pain at the injection site and muscles aches were highest after the first (unblinded) dose. Systemic muscle aches, drowsiness and nausea were common after all doses. Fever was not common and AEs did not interfere with study completion (120/121 participants received three doses). The safety profile in this age group and using this schedule is similar to that observed in younger adolescents.

    Joanne M. Langley, MD, FRCPC, FSHEA1, Soren Gantt, MD, PhD2, Caroline Quach, MD, MSc, FRCPC, FSHEA3, Joenel Alcantara, PhD4, Julie a. Bettinger, PhD5, Scott Halperin, MD6, Brian J. Ward, MD7, Shelly Mcneil, MD, FRCPC, FIDSA8, Jill Mutch, BScN9, Donna Mackinnon-Cameron, MMath8, Kim Marty, BSc10 and David Scheifele, MD11, (1)Pediatrics, Canadian Center for Vaccinology (Dalhousie University, IWK Health Centre and Nova Scotia Health Authority), Halifax, NS, Canada, (2)University of British Columbia, Vancouver, BC, Canada, (3)Quebec Institute of Public Health, Montreal, QC, Canada, (4)Department of Microbiology, Immunology & Infectious Diseases, University of Calgary, Calgary, AB, Canada, (5)Pediatrics, Vaccine Evaluation Center, University British Columbia, Vancouver, BC, Canada, (6)Dalhousie University, Canadian Center for Vaccinology, IWK Health Centre, Halifax, NS, Canada, (7)Research Institute of the McGill University Health Center, Montreal, QC, Canada, (8)Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Halifax, NS, Canada, (9)Canadian Center for Vaccinology., Halifax, NS, Canada, (10)Pediatrics, Vaccine Evaluation Center, University of British Columbia, Vancouver, BC, Canada, (11)British Columbia Children's Hospital, Vancouver, BC, Canada

    Disclosures:

    J. M. Langley, Pfizer, GSK: Investigator , Research grant

    S. Gantt, None

    C. Quach, None

    J. Alcantara, None

    J. A. Bettinger, None

    S. Halperin, None

    B. J. Ward, Pfizer: Investigator , Grant recipient

    S. Mcneil, Sanofi pasteur, GSK, Merck, Novartis: Investigator , Grant recipient

    J. Mutch, None

    D. Mackinnon-Cameron, None

    K. Marty, None

    D. Scheifele, None

    See more of: Clinical Trials
    See more of: Poster Abstract Session

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.