HIV InfectionsPhase 4NCT01002040
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV
A Phase 4 study testing Arepanrix in people with HIV Infections and H1N1 Influenza, run by University of British Columbia at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- HIV Infections, H1N1 Influenza
- What is being tested?
- Arepanrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesCanada
- Study dates
- Feb 2010to Aug 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Laboratory-confirmed HIV
- Written informed consent
- Adults 20-59 years of age
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Dalhousie University
Halifax, Nova Scotia
McGill University
Montreal, Quebec
University of Ottawa / Ottawa Hospital Research Institute
Ottawa, Ontario
University of Toronto
Toronto, Ontario
About this study
Official title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection
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.
Read the 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.
- Conditions
- HIV Infections, H1N1 Influenza
- Being tested
- Arepanrix
- Keywords
- HIV, vaccine,, H1N1, influenza, H1N1 Influenza vaccine, Arepanrix, Pandemic, H1N1 2009 Influenza, HIV preventive vaccine
- Medical subject headings
- HIV Infections, Orthomyxoviridae Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArepanrixBiological
Group A receives one dose of Arepanrix
ArepanrixBiological
Group B receives 2 doses of Arepanrix 3 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| One Dose Influenza vaccine | Active comparator | Arepanrix H1N1 Influenza vaccine (one dose) Receives: Biological: Arepanrix |
| Two Doses Influenza vaccine | Active comparator | Arepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart) Receives: Biological: Arepanrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Measured: 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
Measured: Day 7 and Day 21 post vaccination
Secondary outcomes (1)
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Measured: Day 21 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- David Scheifele, MD, Principal investigator, University of British ColumbiaCurtis Cooper, MD, Study director, University of Ottawa / Ottawa Hospital Research Institute,Marina Klein, MD, Study director, McGill UniversityBrian Ward, MD, Study director, McGill UniversitySharon Walmsley, MD, Study director, University of TorontoAllison McGeer, MD, Study director, University of TorontoDavid Hasse, MD, Study director, Dalhousie UniversityShelly McNeil, MD, Study director, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002040
- Sponsor's protocol ID
- H09-02820
- Status last verified
- Apr 2015
- First submitted
- 23 Oct 2009
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22306585
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults With Human Immunodeficiency Virus Infection
- ClinicalTrials.gov ID
- NCT01002040
- Acronym / sponsor ID
- H09-02820
- Conditions
- HIV Infections, H1N1 Influenza
- Keywords
- HIV, vaccine,, H1N1, influenza, H1N1 Influenza vaccine, Arepanrix, Pandemic, H1N1 2009 Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Dose Influenza vaccine | Active comparator | Biological: ArepanrixArepanrix H1N1 Influenza vaccine (one dose) |
| Two Doses Influenza vaccine | Active comparator | Biological: ArepanrixArepanrix H1N1 Influenza vaccine (2 doses, 3 weeks apart) |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Laboratory-confirmed HIV
- Written informed consent
- Adults 20-59 years of age
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArepanrixGroup A receives one dose of Arepanrix | Biological | One Dose Influenza vaccine |
| ArepanrixGroup B receives 2 doses of Arepanrix 3 weeks apart | Biological | Two Doses Influenza vaccine |
Primary outcome
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Time frame: 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
Time frame: Day 7 and Day 21 post vaccination
1 secondary outcome
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Time frame: Day 21 post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Derived from this study: PubMed 22306585Cooper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Scheifele, MD principal investigator
University of British Columbia
Curtis Cooper, MD study director
University of Ottawa / Ottawa Hospital Research Institute,
Marina Klein, MD study director
McGill University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arepanrix in people with HIV Infections and H1N1 Influenza, run by University of British Columbia at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AEs) for days 0-6 after each vaccination (time frame: Day 7 and Day 21 post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.