Clinical trial NCT01002040: Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
H1N1 Influenza
Keywords: HIV
vaccine,
H1N1
influenza
H1N1 Influenza vaccine
Arepanrix
Pandemic
H1N1 2009 Influenza
HIV preventive vaccine
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: GlaxoSmithKline
First posted: 2009-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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:

1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults with HIV infection.
2. To compare immune responses of subjects randomized to receive either one or two doses of adjuvanted vaccine to identify the optimal regimen.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of adverse events (AEs) for days 0-6 after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
measure: Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination
timeFrame: Day 7 and Day 21 post vaccination
Secondary outcomes:
measure: Immunogenicity: Comparison of baseline and post-immunization antibody titres
timeFrame: Day 21 post vaccination
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Ottawa
country: Canada
facility: University of Ottawa / Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: University of British Columbia
name: David Scheifele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa / Ottawa Hospital Research Institute,
name: Curtis Cooper, MD
role: STUDY_DIRECTOR
affiliation: McGill University
name: Marina Klein, MD
role: STUDY_DIRECTOR
affiliation: McGill University
name: Brian Ward, MD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Sharon Walmsley, MD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Allison McGeer, MD
role: STUDY_DIRECTOR
affiliation: Dalhousie University
name: David Hasse, MD
role: STUDY_DIRECTOR
affiliation: Dalhousie University
name: Shelly McNeil, MD
role: STUDY_DIRECTOR
References:
citation: Cooper C, Klein M, Walmsley S, Haase D, MacKinnon-Cameron D, Marty K, Li Y, Smith B, Halperin S, Law B, Scheifele D; Phac Cihr Influenza Research Network. High-level immunogenicity is achieved vaccine with adjuvanted pandemic H1N1(2009) and improved with booster dosing in a randomized trial of HIV-infected adults. HIV Clin Trials. 2012 Jan-Feb;13(1):23-32. doi: 10.1310/hct1301-023.