Influenza Vaccine in HIV
The purposes of this research study are:
- to see if there is a difference in the quantity of protective influenza antibodies produced by different doses of the Fluviral vaccine
- to see if these different vaccine dosing schedules reduce flu-like illness and/or reduce laboratory documented influenza in HIV Infected adults.
|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|
- Immunogenicity measured by haemagglutination inhibition (HI) [ Time Frame: baseline, week 4, week 8 and week 20. ] [ Designated as safety issue: No ]
- Frequencies of laboratory confirmed influenza and Frequencies clinical/respiratory illness [ Time Frame: event driven ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: Fluviral||
Other Name: non applicable
|Placebo Comparator: placebo||
Other Name: non applicable
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 . 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 . 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 . 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:
- current standard treatment with influenza vaccine is less efficacious when used in particular subgroups of immune compromised individuals, such as those diagnosed with HIV
- there exists a significant burden of influenza infection in HIV patients that must be addressed in terms of identifying an effective treatment strategy
- 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
- 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
- there is a paucity of published evidence assessing the efficacy of an increased, double-dose of influenza vaccine in this patient population.
- Boulos, D., et al., Estimates of HIV prevalence and incidence in Canada, 2005. Can Commun Dis Rep, 2006. 32(15): p. 165-74.
- Safrin, S., J.D. Rush, and J. Mills, Influenza in patients with human immunodeficiency virus infection. Chest, 1990. 98(1): p. 33-7.
- 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.
- Zanetti, A.R., et al., Safety and immunogenicity of influenza vaccination in individuals infected with HIV. Vaccine, 2002. 20 Suppl 5: p. B29-32.
- Malaspina, A., et al., Compromised B cell responses to influenza vaccination in HIV-infected individuals. J Infect Dis, 2005. 191(9): p. 1442-50.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764998
|Southern Alberta Clinic|
|Calgary, Alberta, Canada, T2R 0X7|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Canada, British Columbia|
|BC Center for Excellence in HIV/Aids|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Downtown Immunodeficiency Clinic / UBC|
|Vancouver, British Columbia, Canada, V6Z 2C7|
|Canada, Nova Scotia|
|QEII HSC, Victoria General Hospital Site|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|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|
|Sunnybrook Health Science Center|
|Toronto, Ontario, Canada, M2N 3M5|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2N2|
|HIV Care Program - Windsor Regional Hospital|
|Windsor, Ontario, Canada, N8W 1E3|
|Immunodeficiency Service, Montreal Chest Institute|
|Montreal, Quebec, Canada, H2X 2P4|
|Principal Investigator:||Curtis Cooper, MD||OHRI|