Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

NCT ID: NCT01002040

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-08-31

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.

Conditions

HIV Infections; H1N1 Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

One Dose Influenza vaccine

Arepanrix H1N1 Influenza vaccine (one dose)

Group Type: ACTIVE_COMPARATOR

Arepanrix

Intervention Type: BIOLOGICAL

Group A receives one dose of Arepanrix

Two Doses Influenza vaccine

Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart)

Group Type: ACTIVE_COMPARATOR

Arepanrix

Intervention Type: BIOLOGICAL

Group B receives 2 doses of Arepanrix 3 weeks apart

Interventions

Arepanrix

Group A receives one dose of Arepanrix

Intervention Type: BIOLOGICAL

Arepanrix

Group B receives 2 doses of Arepanrix 3 weeks apart

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Scheifele, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Curtis Cooper, MD

Role: STUDY_DIRECTOR

University of Ottawa / Ottawa Hospital Research Institute,

Marina Klein, MD

Role: STUDY_DIRECTOR

McGill University

Brian Ward, MD

Role: STUDY_DIRECTOR

McGill University

Sharon Walmsley, MD

Role: STUDY_DIRECTOR

University of Toronto

Allison McGeer, MD

Role: STUDY_DIRECTOR

University of Toronto

David Hasse, MD

Role: STUDY_DIRECTOR

Dalhousie University

Shelly McNeil, MD

Role: STUDY_DIRECTOR

Dalhousie University

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

University of Ottawa / Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

McGill University

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 22306585 (View on PubMed)

Other Identifiers

H09-02820

Identifier Type: -

Identifier Source: org_study_id