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Proportion of IgE-Mediated Allergic Reactions to the 2009-2010 pH1N1 Vaccine
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Proportion of IgE-Mediated Allergic Reactions to the 2009-2010 pH1N1 Vaccine

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  • 1. Proportion of IgE-mediated allergic reactions to the 2009-2010 pH1N1 vaccine Isabelle Rouleau, PhD(c) Faculté de médecine, Université Laval
  • 2. Research Team
    • Authors: Rouleau I (1), Drolet JP (1), Benoit M (1), Lemire C (2), Moore A (3), Banerjee D (4), Paradis L (5), Alizadehfar R (4), Des Roches (6), Chan ES (7) Stark D (7), Warrington R (8), Skowronski DM (9) and De Serres G (1).
    • Affiliation: (1) Centre hospitalier universitaire de Québec, Université Laval (2) Université de Sherbrooke (3) Centre affilié universitaire Hôpital Charles Lemoyne, Université de Sherbrooke (4) McGill University Health Centre, McGill University (5) Centre hospitalier de l’Université de Montréal, Université de Montréal (6) Centre hospitalier Universitaire Sainte-Justine, Université de Montréal (7) University of British Columbia (8) University of Manitoba (9) British Columbia Centre for Disease Control.
  • 3. Allergy to pH1N1 vaccine
    • After 2009-2010 vaccination:
      •  number of cases of anaphylaxis
      •  number of cases of allergic reactions
      • No increase in frequency of ORS
    • ORS is not an IgE dependent reaction
    • True« Vaccine allergy » (IgE-mediated)
      • Probably rare, but too few studies
  • 4. Important distiction
    • Allergy and ORS may look alike:
      • Presentation is fairly similar
      • Delay to onset is similar
      • One is IgE mediated, the other is not
    • IgE-mediation dictates recommendations
      • Dangerous to revaccinate if IgE mediated
      • Not contraindicated for most cases of ORS
        • Recurrences are of similar or milder severity
  • 5. Allergy diagnostic testing
    • Skin testing as a two step process:
      • Prick test (drop of allergen)
      • Intradermal injection
    • A positive response is evaluated by
      • Wheal (papule - effect of histamine)
      • Flare (erythema – axonal reflex)
    • False positives can occur
      • More often with intradermal test (irritant effect)
  • 6. Wheal and flare
  • 7. Study design and participants
    • Objective
      • Estimate the % of patients with IgE mediated reactions to pH1N1 vaccine
    • Case control study:
      • Cases of anaphylaxis, allergy and ORS with onset < 24 hours after vaccination
      • Controls vaccinated w/o any allergic-like reaction < 24 hours after vaccination
  • 8. Participating Centres
    • Hospitals (Quebec)
      • Centre hospitalier universitaire de Québec
      • Centre hospitalier de l’Université de Sherbrooke
      • Centre hospitalier Charles Lemoyne
      • McGill University Health Centre (General / Children’s)
      • Centre hospitalier de l’Université de Montréal
      • Centre hospitalier universitaire Sainte-Justine
    • Hospitals (British Columbia)
      • Children’s and Women’s Health Centre
    • Collaborating Centres
      • University of British Columbia
      • BC Centre for Disease Control
      • University of Manitoba
  • 9. Testing conditions
    • Following conditions were tested:
      • Pos. (Histamine)/Neg. control (Saline)
      • pH1N1 antigen
      • AS03 adjuvant
      • Reconstituted vaccine (same day)
      • Reconstituted vaccine (day old)
      • 2010-2011 seasonal vaccine (subsample)
      • Egg protein (if indicated)
    • 2009-10 Antigens were supplied by GSK
      • Lot under monitoring to ensure stability
  • 10. Study outcomes
    • Prick test was positive if:
      • Wheal ≥ 3 mm over saline, AND
      • Visible flare (erythema)
    • Intradermal test was positive if:
      • Wheal ≥ 5 mm over saline, AND
      • Visible flare (erythema)
    • Proportion of positive is a composite of
      • Positive prick or intradermal test
  • 11. Results
    • From January 18 to March 31st
    • 94 cases and 37 controls (N=131)
      • 65% reported cases of allergy
      • 25% reported cases of ORS
      • 7% reported cases of anaphylaxis
      • 3% clinic referrals
    • 3 cases and 1 controls were excluded
      • No response to histamine
  • 12. Surveillance reports vs. allergists N=91 22 (24.2) 59 (64.8) 7 (7.7) TOTAL 42 (46.2) 13 (59.1) 26 (44.1) 2 (4.8) Other 10 (11.0) 7 (70.0) 2 (3.4) 1 (14.3) ORS 14 (15.4) 0 (0.0) 13 (22.0) 0 (0.0) Allergy 22 (24.2) 2 (9.1) 15 (25.4) 4 (57.1) Anaphylaxis TOTAL N (col. %) ORS N (col. %) Allergy N (col. %) Anaphylaxis N (col. %) Reports   Allergists
  • 13. Proportion of positive skin tests 2 (5.6) 14 (15.4) 2 (5.6) 17 (18.7) To any vaccine component 1 (2.9) 7 (9.7) 2 (5.7) 7 (9.7) Reconstituted vaccine (day old) 2 (5.6) 9 (9.9) 2 (5.6) 10 (11.0) Reconstituted vaccine (same day) 1 (2.8) 6 (6.6) 1 (2.8) 11 (12.1) AS03 adjuvant 0 (0.0) 4 (4.4) 1 (2.8) 6 (6.6) pH1N1 antigen N (%) N (%) N (%) N (%) Controls Cases Controls Cases N (%) Positive (ID 5 mm) N (%) Positive (ID 3 mm)
  • 14. Proportion of positive to prick tests among positives None 0/7 1 (2.9) 7 (9.7) Reconstituted vaccine (day old) None 2/9 (22%) 2 (5.6) 9 (9.9) Reconstituted vaccine (same day) None 2/6 (33%) 1 (2.8) 6 (6.6) AS03 adjuvant None 3/4 (75%) None 4 (4.4) pH1N1 antigen N (%) N (%) N (%) N (%) Controls Cases Controls Cases Positive to Prick test N (%) Positive (ID 5 mm)
  • 15. Positive skin tests (prick or ID of 5 mm) by type of case 7(15.6) 1 (10.0) 1 (7.1) 5 (22.7) 2 (5.6) To any vaccine component 3 (7.7) 1 (12.5) 0 (0.0) 3 (15.8) 2 (5.7) Reconstituted vaccine (day old) 6 (13.3) 0 (0.0) 0 (0.0) 3 (13.6) 2 (5.6) Reconstituted vaccine (same day) 2 (4.4) 1 (10.0) 1 (7.1) 2 (9.1) 1 (2.8) AS03 adjuvant 2 (4.4) 0 (0.0) 1 (7.1) 1 (4.6) 0 (0.0) pH1N1 antigen N (%) N (%) N (%) N (%) N (%) Other ORS Allergy Anaphyl. Controls
  • 16. Positive skin tests (ID 5mm), by component and type of reaction
  • 17. Positives to reconstituted vaccine
    • Our primary outcome is being positive to reconstituted vaccine
      • Skin tests may have false positives
    • Among 9 cases positive to reconstituted vaccine
      • 1 positive to antigen in vaccine
      • 2 positive to adjuvant in vaccine
      • 1 positive to both antigen and adjuvant
      • 5 are negative to both antigen and adjuvant
    • Only 4 are probably « true positives »
      • Proportion of IgE mediated reactions = 4%
      • Reported Anaphylaxis (1); Allergy (2) ; ORS (1)
  • 18. Revaccination of positive cases
    • 4 cases with positive skin tests
      • None had immediate symptoms (< 60 min)
      • 1 reported symptoms (1-24 hours)
        • « Bumpy » rash on neck/face, palpitations, dyspnea (attributed to anxiety) and exacerbated cough 6 hours post vaccination. (Case 161)
  • 19. Revaccination of negative cases
    • 21 cases with positive skin tests
      • 2 had immediate symptoms (< 60 min)
        • Pruritus on neck, hoarse voice, nausea and headache (Allergy, Case 080)
        • Sensation of sublingual edema and pruriginous rash at injection site (Allergy/Anaphylaxis, Case 086)
      • 4 had reported reaction (1-24 hours)
        • Bilateral conjunctivitis with ocular pruritus, sore throat and cough at 20 hours (Case 086)
        • Urticaria with hoarse voice at 8 hours.(Allergy/Anaphylaxis Case 110)
        • Angioedema around, but not at the injection site. (Allergy/Anaphylaxis Case 227)
        • Bilateral conjunctivitis with ocular pruritus, eyelid edema at 24 hours. (ORS, Case 249)
        • Urticaria at the injection site. (Allergy, Case 255)
  • 20. Conclusions
    • Few cases have IgE mediated reactions
      • Similar to basophil activation tests
      • 10% of cases positive to the vaccine
      • Only 4% are allergic to a component
    • Cases classified as anaphylaxis by allergist have more positive skin tests than others
    • Most reactions are not Ig-E mediated Similar to basophil activation tests
  • 21. Conclusions
    • When revaccinated 25-30% of cases experienced an adverse event
      • Similar to basophil activation tests
      • 25% of test positive cases
      • 20-30% of test negative cases
    • If not IgE mediated, what mechanism?
      • Coincidental – postviral immune response
      • Non-specific immune activation (most often)
      • Complement, kinins
      • Late T-cell responses (seems unlikely)
      • Other?
  • 22. PHAC-sponsored components
    • Review of medical consultation by non-participating allergists
      • Obtain allergist and patient consent
      • Copy of medical records of patients tested outside our study protocol
    • In vitro studies
      • Activation of the contact system (kinins)
        • Pandemic vaccine activates contact system
      • Complement pathway
        • In the next few months
  • 23. Any questions or comments?