Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by PHAC/CIHR Influenza Research Network.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Institut National en Santé Publique du Québec
Laval University
University of British Columbia
Stollery Children's Hospital
University of Manitoba
University of Toronto
Centre Hospitalier Universitaire de Québec, CHU de Québec
Hospital St. Justine
Centre Hospitalier Universitaire de Sherbrooke
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal Children's Hospital of the MUHC
Montreal General Hospital
Hopital Charles Lemoyne
IWK Health Centre
Université de Montréal
University of Cincinnati
McMaster University
Public Health Agency of Canada (PHAC)
British Columbia Centre for Disease Control
Information provided by (Responsible Party):
Gaston De Serres, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier:
NCT01247415
First received: November 22, 2010
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

During the 2009-2010 immunization campaign against pandemic H1N1, some people reported having allergic-like reactions (anaphylaxis(a shock-like reaction), hives, swelling, etc.). A vaccine allergy may be more or less severe or intense. Patients may have skin reactions (rash with or without itching), respiratory problems (cough, spasm of the airways), angioedema (swelling) of various body parts (face, eyelids, throat etc.) and circulatory problems (low blood pressure or shock). Anaphylaxis is a severe allergic reaction that can sometimes be fatal. Other people vaccinated against pandemic H1N1 had an oculo-respiratory syndrome. Oculo-respiratory syndrome (ORS) is also a reaction to the influenza vaccine, which includes symptoms such as bilateral conjunctivitis (red eyes) with swelling of the face or respiratory symptoms (chest tightness, coughing, a sensation of throat closure, difficulty swallowing, hoarseness, wheezing or difficulty breathing). The investigators know that ORS is not a true allergic reaction. Because many signs and symptoms of ORS are similar to those observed during an allergic reaction, it is often difficult to distinguish ORS from an allergic reaction.

This study will compare three groups of patients: those who had allergic-like reactions, those who had ORS and vaccinated individuals who had no such adverse events. Pregnant women cannot participate in this study. The study has three goals. First, the investigators want to determine, among those who had allergic-like reactions after influenza vaccination, what proportion (percentage) of these people are actually allergic to the vaccine or its components. Second, among those who are not allergic to the vaccine, which other processes may have caused these symptoms. Finally, the investigators will try to identify whether there are features that distinguish patients who have a true allergic reaction from those affected by ORS, and those that had no adverse events.


Condition
Anaphylaxis
Allergy
Oculorespiratory Syndrome
Allergic-like Reactions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical Investigation of Anaphylaxis, Allergic-like Reactions and Oculo-Respiratory Syndrome (ORS) Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza

Resource links provided by NLM:


Further study details as provided by PHAC/CIHR Influenza Research Network:

Primary Outcome Measures:
  • proportion of individuals with IgE mediated allergic reaction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The overall objective of this clinical investigation is to estimate the proportion of individuals with IgE mediated allergic reaction to Arepanrix or its components among patients with anaphylaxis/allergic reaction after pH1N1 vaccination, and the proportion that are allergic to the 2010-2011 trivalent inactivated seasonal influenza vaccine (TIV).


Secondary Outcome Measures:
  • Biomarkers that may allow differentiation between ORS and type I hypersensitivity [ Time Frame: two year ] [ Designated as safety issue: Yes ]
    We will try to identify biomarkers that may allow differentiation of patients with ORS and those with type I hypersensitivity to the vaccine.


Biospecimen Retention:   Samples With DNA

whole blood,PBMC and serum


Enrollment: 138
Study Start Date: January 2011
Estimated Study Completion Date: November 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Anaphylaxis
Anaphylaxis: these patients will have to meet at least level 3 of diagnostic certainty according to the Brighton Collaboration criteria for anaphylaxis
Allergic-like reactions
Allergic-like reactions: These patients will have to have displayed at least one sign or symptom of an allergic reaction (any of the minor or major criteria of anaphylaxis) but will exclude patients with conjunctivitis who will belong to the ORS group
ORS cases
ORS cases: According to the Public Health Agency case definition, these patients should have presented a bilateral conjunctivitis plus ≥1 of the seven respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that started within 24 hrs of vaccination, with or without facial oedema (no restriction for duration) (ref: Public Health Agency of Canada: User Guide: Report of Adverse Events Following Immunization (AEFI) Appendix III National Case Definitions of AEFIs of Special Interest: oculo-respiratory Syndrome. http://www.phac-pc.gc.ca/im/aefi_guide/ann3-eng.php
Controls
Controls will be individuals who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine.

  Eligibility

Ages Eligible for Study:   10 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

During the 2009-2010 immunization campaign against pandemic H1N1, the Canada has immunized most of its population with a dose-sparing adjuvanted vaccine produced by GlaxoSmithKline (GSK). Following the vaccination, some people reported having allergic-like reactions (anaphylaxis, oculo-respiratory syndrome and allergy). This study will compare three groups of patients (cases): those who had allergic-like reactions, those who had anaphylaxis and those who had ORS post vaccination to vaccinated individuals who had no such adverse events (controls).

Criteria

case:

Inclusion Criteria:

  • There will be three groups of cases. For all groups of cases, patients will be included if the time of onset of their first symptoms has been within 24 hours after vaccination and if they are between 10 and 64 years of age.
  • Anaphylaxis: these patients will have to meet at least level 3 of diagnostic certainty according to the Brighton Collaboration criteria for anaphylaxis
  • Allergic-like reactions: These patients will have to have displayed at least one sign or symptom of an allergic reaction (any of the minor or major criteria of anaphylaxis) but will exclude patients with conjunctivitis who will belong to the ORS group (see below).
  • ORS cases: According to the Public Health Agency case definition, these patients should have presented a bilateral conjunctivitis plus ≥1 of the seven respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that started within 24 hrs of vaccination, with or without facial oedema (no restriction for duration)
  • Controls will be individuals between 10 and 64 years of age who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine (anaphylaxis, allergic like reactions and SOR).

Exclusion Criteria:

-Pregnant women cannot participate in this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247415

Locations
Canada, Quebec
Centre Hospitalier Charles Lemoyne
Greenfield-Park, Quebec, Canada, J4V2H1
Centre Hospitalier Universitaire de Montréal
Montréal, Quebec, Canada, H2L4M1
Hôpitale Ste-Justine
Montréal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital
Montréal, Quebec, Canada, H3H1P3
Montreal General Hospital
Montréal, Quebec, Canada, H3G1A4
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1V 4V2
Centre Hospitalier et Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
PHAC/CIHR Influenza Research Network
Institut National en Santé Publique du Québec
Laval University
University of British Columbia
Stollery Children's Hospital
University of Manitoba
University of Toronto
Centre Hospitalier Universitaire de Québec, CHU de Québec
Hospital St. Justine
Centre Hospitalier Universitaire de Sherbrooke
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal Children's Hospital of the MUHC
Montreal General Hospital
Hopital Charles Lemoyne
IWK Health Centre
Université de Montréal
University of Cincinnati
McMaster University
Public Health Agency of Canada (PHAC)
British Columbia Centre for Disease Control
  More Information

No publications provided

Responsible Party: Gaston De Serres, Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier: NCT01247415     History of Changes
Other Study ID Numbers: pcirn-clin-invest-aller-1011
Study First Received: November 22, 2010
Last Updated: July 3, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by PHAC/CIHR Influenza Research Network:
anaphylaxis
allergy
IgE mediated
ORS
oculorespiratory syndrome
Allergic-like reactions
H1N1
Arepanrix

Additional relevant MeSH terms:
Hypersensitivity
Anaphylaxis
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 29, 2014