Influenza Vaccine in HIV

This study has been completed.
Sponsor:
Collaborators:
Ontario HIV Treatment Network
Public Health Agency of Canada (PHAC)
CIHR Canadian HIV Trials Network
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00764998
First received: October 1, 2008
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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.

Condition Intervention Phase
Influenza
HIV
Biological: Fluviral
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Controlled Trial to Assess the Immunogenicity and Efficacy of Three Vaccine Dosing Strategies in HIV Infected Adults

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Immunogenicity measured by haemagglutination inhibition (HI) [ Time Frame: baseline, week 4, week 8 and week 20. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequencies of laboratory confirmed influenza and Frequencies clinical/respiratory illness [ Time Frame: event driven ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluviral Biological: Fluviral
Other Name: non applicable
Placebo Comparator: placebo Biological: Fluviral
Other Name: non applicable

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764998

Locations
Canada, Alberta
Southern Alberta Clinic
Calgary, Alberta, Canada, T2R 0X7
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Downtown Immunodeficiency Clinic / UBC
Vancouver, British Columbia, Canada, V6Z 2C7
BC Center for Excellence in HIV/Aids
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
QEII HSC, Victoria General Hospital Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 4A6
Infectious Disease Care Program
London, Ontario, Canada, N5Y 3H6
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
University of Ottawa Health Services
Toronto, Ontario, Canada, K1N 6N5
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sunnybrook Health Science Center
Toronto, Ontario, Canada, M2N 3M5
HIV Care Program - Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 1E3
Canada, Quebec
Immunodeficiency Service, Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario HIV Treatment Network
Public Health Agency of Canada (PHAC)
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Curtis Cooper, MD OHRI
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Curtis Cooper, OHRI
ClinicalTrials.gov Identifier: NCT00764998     History of Changes
Other Study ID Numbers: CTN237
Study First Received: October 1, 2008
Last Updated: August 19, 2010
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Influenza
HIV
Influenza Vaccine
Efficacy

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014