Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in HIV-infected adults. The study will enroll 150 adults (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 days.

Detailed Description
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During the first wave of the H1N12009 pandemic in Canada, adults with immune deficiency were more likely to die with severe infections than were other Canadians. Of 76 deaths attributed to date to this new virus, 37% occurred in persons with immune system compromise. Adults with human immunodeficiency virus (HIV) infection constitute a significant proportion of the at-risk population with over 56,000 affected individuals. Most such individuals retain some capacity to respond to influenza vaccination. The dosing regimen for the pandemic vaccine will be based on limited studies in the general population, leaving open the question of whether HIV-infected persons can respond satisfactorily to the recommended dosing. Availability of an adjuvanted formulation of the pandemic vaccine may improve responsiveness but two doses may be required for the best possible response. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest HIV-infected persons to receive it, to inform the subsequent vaccination of others. The objectives of this study are three-fold: To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults with HIV infection. To compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen. To complete this evaluation soon after the pandemic vaccine becomes available so as to inform the subsequent use of the vaccine in HIV-infected persons.

Official Title
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PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection

Conditions
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HIV Infections, H1N1 Influenza

Intervention / Treatment
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* Biological: Arepanrix
* Biological: Arepanrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laboratory-confirmed HIV Written informed consent Adults 20-59 years of age Exclusion Criteria: Allergies to eggs, thimerosal or gentamicin sulphate Life-threatening reaction to previous Flu vaccine Bleeding disorder Pregnancy Receipt of blood or blood products in past 3 months Chronic illness Previous lab-confirmed H1N12009 infection Receipt of any non-study H1N12009 or Seasonal Influenza vaccine for 2009/10

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One Dose Influenza vaccine<br>Arepanrix H1N1 Influenza vaccine (one dose) | Biological: Arepanrix<br>* Group A receives one dose of Arepanrix<br>|
| Active Comparator: Two Doses Influenza vaccine<br>Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart) | Biological: Arepanrix<br>* Group B receives 2 doses of Arepanrix 3 weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) for days 0-6 after each vaccination |  | Day 7 and Day 21 post vaccination | 
| Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination |  | Day 7 and Day 21 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: Comparison of baseline and post-immunization antibody titres |  | Day 21 post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, vaccine,, H1N1, influenza, H1N1 Influenza vaccine, Arepanrix, Pandemic, H1N1 2009 Influenza, HIV preventive vaccine