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IRCT2015101724575N1 IRCT 2017-06-04 Vice chancellor for research, Shahid Beheshti University of Medical Sciences Comparing different methods of trivalent influenza vaccination on the post-vaccination immunogenicity in patients on maintenance hemodialysis Comparing intramuscular and intradermal injection of trivalent influenza vaccine, and topical imiquimod use before intradermal vaccination, on the post-vaccination immunogenicity, in patients on maintenance hemodialysis: A randomized clinical trial 2016-02-04 anticipated 120 Complete https://irct.ir/trial/20710 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Randomization was done by means of random table of digits; Patients were informed about the goals of study, to the extent that further assignment and randomization would not be interfered, and they were aware that participation was completely facultative. The volunteers then asked to sign the written consent before initiation of study. 3 Need for immunization against influenza. Intervention 1: The first group (Intervention): 250mg Imiquimod 5% cream (Aldara) was rubbed on deltoid region of right arm, and after 15 minutes, 0.25cc of trivalent influenza vaccine was injected intradermal. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine. Intervention 2: The second group (Intervention/Control): received 0.25cc trivalent influenza vaccine via intradermal route after rubbing 250 mg aqueous cream in the same region with the same prior interval. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine. Intervention 3: The third group (control): 0.5 cc trivalent influenza vaccine was injected intramuscular after using 250 mg aqueous topical cream on the same area. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine.
public Zahra Doosti
Infectious Diseases and Tropical Medicine Research Center, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Shahid A'arabi street, Yaman street, Chamran highway, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 4481 2171 z.doosti@sbmu.ac.ir; sayeroshan1383@gmail.com Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sci scientific Zahra Doosti
Infectious Diseases and Tropical Medicine Research Center, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Shahid A'arabi street, Yaman street, Chamran highway, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 4481 2171 z.doosti@sbmu.ac.ir; sayeroshan1383@gmail.com Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sci Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: Individuals more than 18 years old who are known to have end stage renal disease and need routine dialysis (i.e. at least 2 times a week for more than one month). Exclusion criteria: History of influenza or other viral diseases and also live viral vaccination in recent 4 weeks; History of influenza vaccination in prior 6 months; Prior history of hypersensitivity to egg, components of influenza vaccine; Documented primary or secondary immunosuppression especially impaired cellular and humoral immunity. 18 years 100 years Both Z25.1 Need for immunization against influenza Treatment - Drugs Placebo Prevention The first group (Intervention): 250mg Imiquimod 5% cream (Aldara) was rubbed on deltoid region of right arm, and after 15 minutes, 0.25cc of trivalent influenza vaccine was injected intradermal. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine. The second group (Intervention/Control): received 0.25cc trivalent influenza vaccine via intradermal route after rubbing 250 mg aqueous cream in the same region with the same prior interval. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine. The third group (control): 0.5 cc trivalent influenza vaccine was injected intramuscular after using 250 mg aqueous topical cream on the same area. The applied inactivated trivalent influenza vaccines in this study, complied with the WHO recommendations for northern hemisphere and European Union decision for the 2015/2016 season, and contained seasonal split-virus of theses strains: -A/California/07/2009 (H1N1)pdm09–like strain, -Influenza A/Switzerland/9715293/2013 (H3N2)–like strain and -Influenza B/Phuket/3073/2013. They contained 15 μg hemagglutinin of each strain per 0.5 cc of the vaccine. Comparing the immunogenicity against influenza vaccine via intradermal and intramuscular routes. Timepoint: Obtaining blood samples for antibody titration, before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test. The effect of imiquimod pretreatment before intradermal influenza vaccination on immunogenicity of vaccine. Timepoint: Antibody titration within blood samples obtained before and 14 to 21 days after vaccination. Method of measurement: Antibody titration within the sera obtained before and after vaccination, by hemagglutination inhibition assay test. Vice chancellor for research, Shahid Beheshti University of Medical Sciences Approved 2016-02-02 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid A'arabi street, Yaman street, Chamran highway, Tehran, Iran Tehran Iran (Islamic Republic of)