Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV - Full Text View

Sponsor:	University of British Columbia
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT01002040

Purpose

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.

Condition	Intervention	Phase
HIV Infections H1N1 Influenza	Biological: Arepanrix	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Group A: One dose of H1N1 vaccine	Biological: Arepanrix Group A receives one dose of Arepanrix
2 Group B: Two doses of H1N1 vaccine given 3-4 weeks apart	Biological: Arepanrix Group B receives 2 doses of Arepanrix 3 weeks apart

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:

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.

Eligibility

Ages Eligible for Study:	20 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002040

Contacts

Contact: Carol LaJeunesse

604 875-2860

clajeunesse@cw.bc.ca

Locations

Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Ontario
University of Ottawa / Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
Canada, Quebec
McGill University
Montreal, Quebec, Canada

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:	David Scheifele, MD	University of British Columbia
Study Director:	Curtis Cooper, MD	University of Ottawa / Ottawa Hospital Research Institute,
Study Director:	Marina Klein, MD	McGill University
Study Director:	Brian Ward, MD	McGill University
Study Director:	Sharon Walmsley, MD	University of Toronto
Study Director:	Allison McGeer, MD	University of Toronto
Study Director:	David Hasse, MD	Dalhousie University
Study Director:	Shelly McNeil, MD	Dalhousie University

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. David Scheifele )
Study ID Numbers:	H09-02820
Study First Received:	October 23, 2009
Last Updated:	November 6, 2009
ClinicalTrials.gov Identifier:	NCT01002040 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

HIV
vaccine,
H1N1
influenza
H1N1 Influenza vaccine

Arepanrix
Pandemic
HIV
H1N1 2009 Influenza
HIV preventive vaccine

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Orthomyxoviridae Infections
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Sexually Transmitted Diseases
Influenza, Human
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010