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      Zanamivir versus trivalent split virus influenza vaccine: a pilot randomized trial

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          Abstract

          Background

          Healthcare workers may be exposed to people with respiratory viral infections more often than other working adults. Understanding the risk and the effectiveness of different preventive measures is of great importance.

          Objectives

          To estimate adherence to prophylactic antiviral medication for a full influenza season, to the compare efficacy of antiviral prophylaxis to that of the seasonal influenza vaccine and to identify exposures that increase risk of acute respiratory illnesses (ARI) in healthy adults.

          Methods

          Participants were randomized 1:2 to receive the 2008–2009 influenza vaccine or daily prophylaxis with 10 mg of zanamivir during the season. Web-based questionnaires collected information on demographics, symptoms, exposures, medication use and side effects.

          Results

          Sixty-four healthy adults were recruited in November 2008. Three of 40 active participants discontinued zanamivir due to side effects; the remaining 37 took >85% of scheduled doses for a median of 121 days. Symptomatic, laboratory-confirmed influenza was detected in one person randomized to zanamivir (2·5%) and 2/20 (10%) who received the vaccine ( P = 0·25). Forty-seven participants reported 109 episodes of ARI. Factors associated with an ARI were exposure to a spouse (OR 7·2), child (OR 2·4) or patient (OR 2·0) with symptoms of an ARI in the previous 7 days.

          Conclusions

          Breakthrough influenza infection occurred in both vaccinated participants and those receiving antiviral prophylaxis. Most adults were willing and able to comply with season-long prophylaxis. Report of recent exposure to family members and patients with an ARI increased the risk of developing an ARI in healthy adults.

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          Most cited references18

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          Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza.

          Safe and effective antiviral agents are needed to prevent infection with influenza A and B virus. Oseltamivir (GS4104), which can be administered orally, is the prodrug of GS4071, a potent and selective inhibitor of influenzavirus neuraminidases. We studied the use of oseltamivir for long-term prophylaxis against influenza in two placebo-controlled, double-blind trials at different U.S. sites during the winter of 1997-1998. We randomly assigned 1559 healthy, nonimmunized adults 18 to 65 years old to receive either oral oseltamivir (75 mg given once or twice daily, for a total daily dose of 75 or 150 mg) or placebo for six weeks during a peak period of local influenzavirus activity. The primary end point with respect to efficacy was laboratory-confirmed influenza-like illness (defined as a temperature of at least 37.2 degrees C accompanied by at least one respiratory and at least one systemic symptom). In the two studies combined, the risk of influenza among subjects assigned to either once-daily or twice-daily oseltamivir (1.2 percent and 1.3 percent, respectively) was lower than that among subjects assigned to placebo (4.8 percent; P<0.001 and P=0.001 for the comparison with once-daily and twice-daily oseltamivir, respectively). The protective efficacy of oseltamivir in the two active-treatment groups combined was 74 percent (95 percent confidence interval, 53 to 88 percent) at all the sites combined and 82 percent (95 percent confidence interval, 60 to 93 percent) at sites in Virginia, where the rate of influenza infection was higher than the overall rate. For culture-proved influenza, the rate of protective efficacy in the two oseltamivir groups combined was 87 percent (95 percent confidence interval, 65 to 96 percent). The rate of laboratory-confirmed influenza infection was lower with oseltamivir than with placebo (5.3 percent vs. 10.6 percent, P<0.001). Oseltamivir was well tolerated but was associated with a greater frequency of nausea (12.1 percent and 14.6 percent in the once-daily and twice-daily groups, respectively) and vomiting (2.5 percent and 2.7 percent, respectively) than was placebo (nausea, 7.1 percent; vomiting, 0.8 percent). However, the frequency of premature discontinuation of drug or placebo was similar among the three groups (3.1 to 4.0 percent). Oseltamivir administered daily for six weeks by the oral route is safe and effective for the prevention of influenza.
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            Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP).

            , (2011)
            This report updates the previously published summary of recommendations for vaccinating health-care personnel (HCP) in the United States (CDC. Immunization of health-care workers: recommendations of the Advisory Committee on Immunization Practices [ACIP] and the Hospital Infection Control Practices Advisory Committee [HICPAC]. MMWR 1997;46[No. RR-18]). This report was reviewed by and includes input from the Healthcare (formerly Hospital) Infection Control Practices Advisory Committee. These updated recommendations can assist hospital administrators, infection-control practitioners, employee health clinicians, and HCP in optimizing infection prevention and control programs. The recommendations for vaccinating HCP are presented by disease in two categories: 1) those diseases for which vaccination or documentation of immunity is recommended because of risks to HCP in their work settings for acquiring disease or transmitting to patients and 2) those for which vaccination might be indicated in certain circumstances. Background information for each vaccine-preventable disease and specific recommendations for use of each vaccine are presented. Certain infection-control measures that relate to vaccination also are included in this report. In addition, ACIP recommendations for the remaining vaccines that are recommended for certain or all adults are summarized, as are considerations for catch-up and travel vaccinations and for work restrictions. This report summarizes all current ACIP recommendations for vaccination of HCP and does not contain any new recommendations or policies. The recommendations provided in this report apply, but are not limited, to HCP in acute-care hospitals; long-term-care facilities (e.g., nursing homes and skilled nursing facilities); physician's offices; rehabilitation centers; urgent care centers, and outpatient clinics as well as to persons who provide home health care and emergency medical services.
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              Zanamivir in the prevention of influenza among healthy adults: a randomized controlled trial.

              The neuraminidase inhibitor zanamivir, a sialic acid analog administered directly to the respiratory tract, has been demonstrated in clinical studies to be effective in treatment of type A and B influenza. It has also been shown to prevent influenza infection and disease in an experimental model. To examine the efficacy of zanamivir, administered once daily, in the prevention of influenza infection and disease. Double-blind, randomized, placebo-controlled trial. Two midwestern university communities. A total of 1107 healthy adults (mean age [range], 29 [18-69] years) were recruited in November 1997, before the influenza season. At the start of the influenza outbreak, 554 subjects were randomized to receive placebo and 553 to receive zanamivir. The drug, 10 mg once per day, or identical placebo was administered by oral inhalation for a 4-week period. Illness occurrence was recorded by participants daily and records were evaluated weekly. Specimens were collected for viral isolation when symptoms were reported within 3 days of illness onset. Infection was also identified by testing paired serum samples for rise in antibody titer against the circulating influenza viruses. Zanamivir was 67% efficacious (95% confidence interval [CI], 39%-83%; P<.001) in preventing laboratory-confirmed clinical influenza meeting the case definition and 84% efficacious (95% CI, 55%-94%; P=.001) in preventing laboratory-confirmed illnesses with fever. All influenza infections occurring during the season, with or without symptoms, were prevented with an efficacy of 31% (95% CI, 4%-50%; P=.03). The nature and incidence of adverse events in the zanamivir group did not differ from placebo. Compliance with the once-daily dosage was high. Zanamivir administered once daily is efficacious and well tolerated in the prevention of influenza for a 4-week period in healthy adults.
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                Author and article information

                Journal
                Influenza Other Respir Viruses
                Influenza Other Respir Viruses
                irv
                Influenza and Other Respiratory Viruses
                BlackWell Publishing Ltd (Oxford, UK )
                1750-2640
                1750-2659
                March 2015
                04 January 2015
                : 9
                : 2
                : 78-84
                Affiliations
                [a ]Dalla Lana School of Public Health, University of Toronto Toronto, ON, Canada
                [b ]Department of Microbiology, Mount Sinai Hospital Toronto, ON, Canada
                [c ]ProvLab Calgary, AB, Canada
                [d ]Microbiology, Immunology and Infectious Diseases, University of Calgary Calgary, AB, Canada
                [e ]Department of Pathology, Dalhousie University Halifax, NS, Canada
                [f ]Department of Pathology and Laboratory Medicine, Queen Elizabeth Health Sciences Centre Halifax, NS, Canada
                Author notes
                Correspondence: Brenda L. Coleman, Mount Sinai Hospital, 600 University Avenue, Toronto, ON M5G 1X5, Canada., E-mail: b.coleman@ 123456utoronto.ca

                Place of clinical trial: Mount Sinai Hospital , 600 University Avenue , Toronto, ON M5G 1X5, Canada

                Article
                10.1111/irv.12301
                4353320
                25557838
                a2bdd829-c91a-4873-93ce-49e7d7f5ad24
                © 2015 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 November 2014
                Categories
                Original Articles

                Infectious disease & Microbiology
                adult,antiviral,influenza,respiratory tract infections
                Infectious disease & Microbiology
                adult, antiviral, influenza, respiratory tract infections

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