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

July 3, 2012 updated by: Gaston De Serres, PHAC/CIHR Influenza Research Network

Clinical Investigation of Anaphylaxis, Allergic-like Reactions and Oculo-Respiratory Syndrome (ORS) Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Greenfield-Park, Quebec, Canada, J4V2H1
        • Centre Hospitalier Charles Lemoyne
      • Montréal, Quebec, Canada, H2L4M1
        • Centre Hospitalier Universitaire de Montréal
      • Montréal, Quebec, Canada, h3g1a4
        • Montreal General Hospital
      • Montréal, Quebec, Canada, H3H1P3
        • Montreal Children's Hospital
      • Montréal, Quebec, Canada, H3T 1C5
        • Hôpitale Ste-Justine
      • Québec, Quebec, Canada, G1V 4V2
        • Centre Hospitalier Universitaire de Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Centre Hospitalier et Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 62 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of individuals with IgE mediated allergic reaction
Time Frame: one year
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).
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers that may allow differentiation between ORS and type I hypersensitivity
Time Frame: two year
We will try to identify biomarkers that may allow differentiation of patients with ORS and those with type I hypersensitivity to the vaccine.
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PHAC/CIHR Influenza Research Network

Collaborators

University of Manitoba
University of British Columbia
CHU de Quebec-Universite Laval
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Centre hospitalier de l'Université de Montréal (CHUM)
McMaster University
University of Toronto
University of Cincinnati
Laval University
IWK Health Centre
Stollery Children's Hospital
St. Justine's Hospital
Université de Montréal
Montreal Children's Hospital of the MUHC
Public Health Agency of Canada (PHAC)
Institut National en Santé Publique du Québec
Montreal General Hospital
British Columbia Centre for Disease Control
Hopital Charles Lemoyne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pcirn-clin-invest-aller-1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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