NCT01002040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4 hiv-infections

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

October 23, 2009

Last Update Submit

April 14, 2015

Conditions

HIV InfectionsH1N1 Influenza

Keywords

HIVvaccine,H1N1influenzaH1N1 Influenza vaccineArepanrixPandemicH1N1 2009 InfluenzaHIV preventive vaccine

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Immunogenicity: Comparison of baseline and post-immunization antibody titres

    Day 21 post vaccination

Study Arms (2)

One Dose Influenza vaccine

ACTIVE COMPARATOR

Arepanrix H1N1 Influenza vaccine (one dose)

Biological: Arepanrix

Two Doses Influenza vaccine

ACTIVE COMPARATOR

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

Biological: Arepanrix

Interventions

ArepanrixBIOLOGICAL

Group A receives one dose of Arepanrix

One Dose Influenza vaccine

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Laboratory-confirmed HIV
  • Written informed consent
  • Adults 20-59 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dalhousie University

Halifax, Nova Scotia, Canada

Location

University of Ottawa / Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

University of Toronto

Toronto, Ontario, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22306585DERIVED

MeSH Terms

Conditions

HIV InfectionsOrthomyxoviridae InfectionsInfluenza, Human

Interventions

arepanrix

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • David Scheifele, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 27, 2009

Study Start

February 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

CA(4)