795. Adverse Events Following Mandatory Vaccination with rLP2086 at College X: An Observational, Longitudinal Study.
Session: Poster Abstract Session: Vaccines: Safety and Adverse Events
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • MENINGBPOSTER.png (146.4 kB)
  • Background:

    In February 2015, two unlinked culture-confirmed cases of Neisseria meningitidis B (MenB) occurred within 3 days at a college in Rhode Island (College X). As this represented a 489-fold increase in MenB disease, an outbreak was declared. Mass vaccination with rLP2086 (Trumenba) was coordinated on campus, the first time rLP2086 was ever used as a mandatory intervention. Given the limited use of rLP2086 outside clinical trials, this outbreak provided a  unique opportunity to collect safety data in a college-age population in a real-world setting.

    Methods:

    Data on side effects were collected using in-person surveys during vaccination clinics, and electronic surveys two months after the final dose. Survey methodology was based on the Dillman method. Student responses were matched over time. Side effect estimates and 95% confidence intervals were generated using generalized mixed modeling where observations are nested within students over time. Side effect estimates from clinical trials are presented for comparison.

    Results:

    1737 subjects were surveyed about dose 1, 1396 about dose 2, and 614 about dose 3. Reported side effects from this population are generally lower than those reported in the larger clinical trials. (See Table 1)

    Conclusion:

    The ACIP recommends MenB vaccination for college-aged individuals, yet safety data for this population is limited. This study is the first to examine side effects of rLP2086 in a real-world setting where 94.1% of a college-age population was vaccinated.

    Table 1.

     

     

    OUR STUDY

    Australian study (Marshall et al.)

    FDA package insert

     

    Age (in years)

    18-26

    18-40

    11-17

     

    n (1st dose)

    1737

    60

    985

     

    n (2nd dose)

    1396

    57

    907

     

    n (3rd dose)

    614

    55

    846

     

    Dose

    Mean (%)

    95% CI

     

     

    Injection site pain

     

    1

    78.1

    [76.1, 80.0]

    91.7

    92.0

     

    2

    64.2

    [61.5, 66.7]

    91.2

    86.7

     

    3

    70.7

    [66.9, 74.2]

    92.7

    85.1

     

    Fatigue

     

     

     

     

    1

    34.8

    [32.5, 37.1]

    60.0

    62.4

     

    2

    30.4

    [28.0, 33.0]

    50.9

    44.8

     

    3

    38.0

    [34.2, 42.0]

    41.8

    42.9

     

    Headaches

     

     

     

     

    1

    15.5

    [13.9, 17.2]

    61.6

    54.8

     

    2

    10.5

    [9.1, 12.2]

    47.4

    40.8

     

    3

    14.5

    [12.0, 17.5]

    49.0

    34.8

     

    Chills

     

     

     

     

    1

    14.6

    [13.0, 16.3]

    11.7

    29.0

     

    2

    13.1

    [11.4, 14.9]

    5.3

    17.4

     

    3

    14.0

    [11.6, 16.9]

    11.0

    15.6

     

    Fevers1

     

     

     

     

    1

    5.6

    [4.6, 6.7]

    23.4

    6.4

     

    2

    5.8

    [4.7, 7.2]

    14.0

    1.3

     

    3

    4.1

    [2.8, 5.9]

    7.2

    1.1

     

    Myalgia

     

     

     

     

     

     

     

    1

    47.2

    [44.8, 49.6]

    40.0

    42.4

     

     

    2

    36.9

    [34.3, 39.5]

    24.5

    30.5

     

     

    3

    15.4

    [12.8, 18.5]

    36.3

    30.9

     

    1Thermometer-confirmed (temperature taken, ≥100.4F reported) fevers

     

    Theresa Fiorito, MD1, Grayson Baird, PhD2, Suzanne Bornschein, MD3, Nan Du, MS44, Catherine Kelleher, RN3, Nicole E. Alexander, MD, MPH5 and Penelope H. Dennehy, MD, FIDSA, FPIDS6, (1)Pediatric Infectious Diseases, Brown University/Hasbro ChildrenĀ“s Hospital, Providence, RI, (2)Lifespan Biostatistics Core, Rhode Island Hosptial/The Warren Alpert Medical School at Brown University, Providence, RI, (3)Providence College, Providence, RI, (4)The Warren Alpert Medical School at Brown University, Providence, RI, (5)Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, RI, (6)Pediatrics, The Alpert Medical School of Brown University, Providence, RI

    Disclosures:

    T. Fiorito, None

    G. Baird, None

    S. Bornschein, None

    N. Du, None

    C. Kelleher, None

    N. E. Alexander, None

    P. H. Dennehy, None

    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.