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 Joanne.Langley@dal.ca 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