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Results Methods Randomized controlled observer-blind multicenter trial comparing an accelerated schedule (0, 21 days) to a standard schedule (0, 2 months) in students 17-25 years of age Conclusions • A rapid multicenter clinical trial was successfully conducted in the fall term of the academic year by the Clinical Trials Network of CIRN • Adverse events were highest and rated more severe following the first unblinded dose of vaccine (4CMenB): – Almost all participants complained of pain after dose 1; 10% of these AE were considered Grade 3 (interfering with normal activity) – >50% reported muscle aches; 38% reported drowsiness; 18% reported nausea – Solicited AE were more commonly assessed as Grade 1-2 after dose 1 • The most common adverse events were pain at the injection site, muscle aches, drowsiness and nausea after all doses • Next steps: hSBA titers to vaccine strains and Meningococcal B outbreak strains from 2015 in Nova Scotia are in progress; safety database lock and analysis in next month Background • Emergency vaccination programs are often needed when outbreaks of Meningococcal B (MenB) disease in adolescents/ young adults in educational settings occur • In Canada one MenB vaccine is authorized (4CMenB, Bexsero, GSK) for persons 2 months through 17 years of age • There are limited data on safety and immunogenicity of 4CMenB in persons >17 years or on various dosing schedules • A two-dose schedule with a shorter dosing interval could induce adequate immunogenicity to end an outbreak and be easier to deliver Acknowledgements Contact information [email protected] Canadian Center for Vaccinology centerforvaccinology.ca Canadian Immunization Research Network http://cirnetwork.ca/ Table 1. Study design Legend: * Phone contact by study staff to complete Day 0-6 safety data in diary card and bring to next visit; # = optional visit to receive second dose of HAV; HAV = Hepatitis A vaccine; 4CMenB = 4 component Meningococcal B vaccine • 121 participants; mean age 21.4 years; 69.4% (n=84) female • Enrolment in 4 weeks, fall 2015 at three Clinical Trials Network CIRN sites • 100% followup to Day 180 • One serious AE (fractured patella) • Fever reported in 2 participants (1.7%) after dose 2 • Adverse Event severity: most Grade 1 and less frequent with subsequent doses (Figure 3); all AE were temporary • Unsolicited Adverse Events: Dose 1 (38%), Dose 2 (28.1%), Dose 3 (19.8%) Outbreaknewstoday.com Figure 1. Local solicited AE days 0-6 Figure 3. Severity of AE by dose 1, 2,3 Figure 2. Systemic AE days 0-6 Grade 1 – noticeable, doesn’t interfere with activity Grade 2 – interferes with activity Grade 3 – prevents normal activity
