AzTrials
AzTrials

InfluenzaPhase 3NCT00764998

Influenza Vaccine in HIV

A Phase 3 study testing Fluviral in people with Influenza and HIV, run by Ottawa Hospital Research Institute at 13 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this research study are: 1. to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine 2. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Influenza, HIV
What is being tested?
Fluviral
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
13 sitesCanada
Study dates
Oct 2008to Aug 2009
Phase
Phase 3
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 - < 60 years
  • HIV positive
  • Able to provide signed, informed consent.

Who cannot join

  • Receipt or anticipated requirement of any blood product, vaccine, or immunoglobulin preparation within one month of study vaccine administration until completion of study.
  • Immunosuppressive therapy including prednisone, immune modulators, subjects undergoing dialysis, autoimmune dysfunction (including rheumatoid arthritis, lupus erythematosus, multiple sclerosis)
  • Alcohol consumption > 4 drinks per day (1 drink is equal to a 12-ounce can of beer, or a 5-ounce glass of wine or one cocktail with 1 1/2-ounces alcohol)
  • History of cancer, with the exception of cutaneous cancers including Kaposi Sarcoma, basal cell carcinoma and non-invasive HPV-related malignancy
  • Known or suspected hypersensitivity to any component of the study vaccines, including chicken eggs or egg products and thimerosol
  • History of immediate hypersensitivity reaction and/or reaction resulting in neurological symptoms to a previous dose of any influenza vaccine
  • Presentation with or any recent history (within 24 hours) of any febrile illness (> 38 C) or symptoms of significant local or systemic infection - such subjects will be deferred from enrollment at least until one week after the illness has resolved
  • Any other condition which in the opinion of the Investigator might interfere with evaluation of the study objectives.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites
  • Southern Alberta Clinic

    Calgary, Alberta, T2R 0X7

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • QEII HSC, Victoria General Hospital Site

    Halifax, Nova Scotia, B3H 1V7

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 4A6

  • Infectious Disease Care Program

    London, Ontario, N5Y 3H6

  • Immunodeficiency Service, Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario, K1H 8L6

  • University of Ottawa Health Services

    Toronto, Ontario, K1N 6N5

  • Sunnybrook Health Science Center

    Toronto, Ontario, M2N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2N2

  • BC Center for Excellence in HIV/Aids

    Vancouver, British Columbia, V6Z 1Y6

  • Downtown Immunodeficiency Clinic / UBC

    Vancouver, British Columbia, V6Z 2C7

  • HIV Care Program - Windsor Regional Hospital

    Windsor, Ontario, N8W 1E3

Other trials in Canada

About this study

Official title: A Controlled Trial to Assess the Immunogenicity and Efficacy of Three Vaccine Dosing Strategies in HIV Infected Adults

The purposes of this research study are:

  1. to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine
  2. to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce laboratory documented influenza in HIV Infected adults.
Read the detailed description

Immune compromised individuals are at risk for infection with influenza and more likely to manifest more severe symptoms of influenza disease. Furthermore, they are influenza vaccine hyporesponsive in comparison to healthy, adult immune competent individuals. One population of immune compromised Canadians at risk for severe influenza disease is those living with HIV infection. At least 56,000 Canadians are HIV infected [1]. This population is at risk for more severe influenza illness. Influenza viral replication and shedding is prolonged and the duration of influenza symptomatology is longer in those with HIV [2, 3]. Furthermore, influenza-related mortality rates in HIV infected individuals are increased [4]. The HIV population is known to be hyporesponsive to vaccinations, including influenza. The efficacy of influenza vaccines is compromised, in part, by reduced antibody responses observed in HIV infected individuals [5]. Nevertheless, influenza vaccination is recommended for HIV-infected individuals [6, 7]. The Centers of Disease Control guidelines state: "Influenza can result in serious illness and because vaccination with inactivated influenza vaccine might result in the production of protective antibody titers, vaccination might benefit HIV-infected persons. Therefore, influenza vaccination is recommended". As influenza vaccination is the cornerstone of public health interventions intended to protect the population against influenza, vaccine hyporesponsiveness in immune compromised populations represents a significant concern. Given the risk of influenza exposure in general as well as concerns related to poor vaccine efficacy and more severe influenza disease in immune compromised populations such as those living with HIV, strategies to improve vaccine efficacy are required.

Therefore a total of 5 conditions provide justification for a trial to be conducted at this time:

  1. current standard treatment with influenza vaccine is less efficacious when used in particular subgroups of immune compromised individuals, such as those diagnosed with HIV
  2. there exists a significant burden of influenza infection in HIV patients that must be addressed in terms of identifying an effective treatment strategy
  3. past randomized trials of influenza vaccination in HIV patients are of limited comparability to today's relevant base of patients, and alternative vaccination strategies require assessment
  4. efficacy of booster doses of influenza vaccine in HIV patients remains in question as a consequence of methodologic shortcomings in terms of both design aspects and outcomes measured of past studies
  5. there is a paucity of published evidence assessing the efficacy of an increased, double-dose of influenza vaccine in this patient population.

References

  1. Boulos, D., et al., Estimates of HIV prevalence and incidence in Canada, 2005. Can Commun Dis Rep, 2006. 32(15): p. 165-74.
  2. Safrin, S., J.D. Rush, and J. Mills, Influenza in patients with human immunodeficiency virus infection. Chest, 1990. 98(1): p. 33-7.
  3. Radwan, H.M., et al., Influenza in human immunodeficiency virus-infected patients during the 1997-1998 influenza season. Clin Infect Dis, 2000. 31(2): p. 604-6.
  4. Zanetti, A.R., et al., Safety and immunogenicity of influenza vaccination in individuals infected with HIV. Vaccine, 2002. 20 Suppl 5: p. B29-32.
  5. Malaspina, A., et al., Compromised B cell responses to influenza vaccination in HIV-infected individuals. J Infect Dis, 2005. 191(9): p. 1442-50.
  6. Health Canada Progress towards Canadian target coverage rates in Influenza and Pneumococcal Immunications., in Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/01vol27/dr2710eb.htlm. Accessed 8 December 2006. 2006.
  7. Prevention and Control of Influenza. Recommendations of the advisory committee on immunization practice, in Centers for Disease Control and Prevention. Morbidity and Morality Weekly Report. 2006. p. Vol 55/RR-10.
Conditions
Influenza, HIV
Being tested
Fluviral
Keywords
Influenza, HIV, Influenza Vaccine, Efficacy
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluviralBiological

    Also called non applicable

Study groups in NCT00764998
Study groupRoleWhat they receive
FluviralActive comparatorNot described
Receives: Biological: Fluviral
placeboPlacebo comparatorNot described
Receives: Biological: Fluviral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity measured by haemagglutination inhibition (HI)

    Measured: baseline, week 4, week 8 and week 20.

Secondary outcomes (1)
  1. Frequencies of laboratory confirmed influenza and Frequencies clinical/respiratory illness

    Measured: event driven

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2009
  4. Study completionAug 2009

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00764998
Sponsor's protocol ID
CTN237
Status last verified
Apr 2017
First submitted
1 Oct 2008
Last updated
28 Apr 2017
Results posted
No

Publications

  • Cooper C, Thorne A, Klein M, Conway B, Boivin G, Haase D, Shafran S, Zubyk W, Singer J, Halperin S, Walmsley S; CIHR Canadian HIV Trials Network Influenza Vaccine Research Group. Immunogenicity is not improved by increased antigen dose or booster dosing of seasonal influenza vaccine in a randomized trial of HIV infected adults. PLoS One. 2011 Mar 25;6(3):e17758. doi: 10.1371/journal.pone.0017758.

    PubMed 21512577
  • Nosyk B, Sharif B, Sun H, Cooper C, Anis AH; CIHR Canadian HIV Trials Network Influenza Vaccine Research Group. The cost-effectiveness and value of information of three influenza vaccination dosing strategies for individuals with human immunodeficiency virus. PLoS One. 2011;6(12):e27059. doi: 10.1371/journal.pone.0027059. Epub 2011 Dec 6.

    PubMed 22162988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluviral in people with Influenza and HIV, run by Ottawa Hospital Research Institute at 13 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Immunogenicity measured by haemagglutination inhibition (HI) (time frame: baseline, week 4, week 8 and week 20.). 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 NCT00764998, which also lists 2 linked publications.

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 28 Apr 2017.

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