Safety and effectiveness of single- versus double-dose of seasonal influenza vaccine in kidney transplant recipients: a randomized clinical trial
- Authors: Meidani M.1, Khatami M.2, Abdollahi A.3, Mirzapour P.4, Karimian E.5, SeyedAlinaghi S.4
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Affiliations:
- Imam Khomeini Hospital, Tehran University of Medical Sciences
- Nephrology Research Center, Tehran University of Medical Sciences
- School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences
- Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences
- School of Medicine, Tehran University of Medical Sciences
- Issue: Vol 14, No 1 (2024)
- Pages: 125-132
- Section: ORIGINAL ARTICLES
- URL: https://journals.rcsi.science/2220-7619/article/view/256773
- DOI: https://doi.org/10.15789/10.15789/2220-7619-SAE-17550
- ID: 256773
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Abstract
Introduction. Influenza virus poses significant risks to immunocompromised individuals such as those who have received organ transplants and are undergoing immunosuppressive treatment to prevent transplant rejection. Therefore, annual influenza vaccination is recommended for these individuals. This study aimed to comparison of safety and effectiveness of single- versus double-dose of seasonal influenza vaccine in kidney transplant recipients.
Materials and methods. This randomized clinical trial involved 50 kidney transplant recipients at Imam Khomeini Hospital. Participants were randomly assigned to two groups: those receiving a single dose (standard dose) and those receiving a double dose of the seasonal flu vaccine. Serum samples were collected before and 4 weeks after vaccination to measure influenza A&B-related antibodies. Sixteen patients were excluded from the study. The trial focused on evaluating the vaccine safety and immunogenicity, as well as documenting any local and systemic side effects following vaccination.
Results. The results indicated no significant difference in gender, age, and type of immunosuppressive drug used between the single- and double-dose groups (p > 0.05). No significant difference in post-vaccination adverse effects, such as injection site pain (p = 0.21) between the two groups. The seroconversion rates (change from IgG < 9 IU/µL to IgG >11 IU/µL) for IgG Influenza A were 12.5% (n = 2) in the single-dose group and 26.7% (n = 4) in the double-dose group, and for IgG Influenza B, they were 11.8% (n = 2) and 21.4% (n = 3), respectively.
Conclusion. A double dose of the influenza vaccine slightly enhanced the immune response in kidney transplant patients without causing any adverse side effects.
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##article.viewOnOriginalSite##About the authors
M. Meidani
Imam Khomeini Hospital, Tehran University of Medical Sciences
Email: s_a_alinaghi@yahoo.com
Associate Professor of Infectious Disease, Department of Infectious Diseases
Iran, Islamic Republic of, TehranM. Khatami
Nephrology Research Center, Tehran University of Medical Sciences
Email: s_a_alinaghi@yahoo.com
Professor of Nephrology
Iran, Islamic Republic of, TehranA. Abdollahi
School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences
Email: s_a_alinaghi@yahoo.com
Professor of Pathology, Department of Pathology
Iran, Islamic Republic of, TehranP. Mirzapour
Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences
Email: s_a_alinaghi@yahoo.com
PhD in Psychology and Postdoc Researcher
Iran, Islamic Republic of, TehranE. Karimian
School of Medicine, Tehran University of Medical Sciences
Email: karimianelnaz@yahoo.com
Infectious Disease Specialist
Iran, Islamic Republic of, TehranS. SeyedAlinaghi
Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences
Author for correspondence.
Email: s_a_alinaghi@yahoo.com
MD, MPhil, PhD, Associate Professor
Iran, Islamic Republic of, TehranReferences
- Chong P.P., Handler L., Weber D.J. A systematic review of safety and immunogenicity of influenza vaccination strategies in solid organ transplant recipients. Clin. Infect. Dis., 2018, vol. 66, no. 11, pp. 1802–1811. doi: 10.1093/cid/cix1081
- Control CfD, Prevention. Seasonal influenza: flu basics. URL: http://www cdc gov/flu/about/disease/index htm [Last accessed: 2017, Feb 20]. 2014.
- Cordero E., Pérez-Romero P., Moreno A., Len O., Montejo M., Vidal E., Martín-Dávila P., Fariñas M.C., Fernández-Sabé N., Giannella M., Pachón J.; Novel influenza A(H1N1) Study Group of Spanish Network for Research in Infectious Diseases (REIPI). Pandemic influenza A(H1N1) virus infection in solid organ transplant recipients: impact of viral and non-viral co-infection. Clin. Microbiol. Infect., 2012, vol. 18, no. 1, pp. 67–73. doi: 10.1111/j.1469-0691.2011.03537.x
- Cordero E., Roca-Oporto C., Bulnes-Ramos A., Aydillo T., Gavaldà J., Moreno A., Torre-Cisneros J., Montejo J.M., Fortun J., Muñoz P., Sabé N., Fariñas M.C., Blanes-Julia M., López-Medrano F., Suárez-Benjumea A., Martinez-Atienza J., Rosso-Fernández C., Pérez-Romero P.; TRANSGRIPE 1–2 Study Group. Two doses of inactivated influenza vaccine improve immune response in solid organ transplant recipients: results of TRANSGRIPE 1-2, a randomized controlled clinical trial. Clin. Infect. Dis., 2017, vol. 64, no. 7, pp. 829–838. doi: 10.1093/cid/ciw855
- El Sahly H.M., Davis C., Kotloff K., Meier J., Winokur P.L., Wald A., Johnston C., George S.L., Brady R.C., Lehmann C., Stokes-Riner A., Keitel W.A. Higher antigen content improves the immune response to 2009 H1N1 influenza vaccine in HIV-infected adults: a randomized clinical trial. J. Infect. Dis., 2012, vol. 205, no. 5, pp. 703–712. doi: 10.1093/infdis/jir837
- GiaQuinta S., Michaels M.G., McCullers J.A., Wang L., Fonnesbeck C., O’Shea A., Green M., Halasa N.B. Randomized, double-blind comparison of standard-dose vs. high-dose trivalent inactivated influenza vaccine in pediatric solid organ transplant patients. Pediatr. Transplant., 2015, vol. 19, no. 2, pp. 219–228. doi: 10.1111/petr.12419
- Iuliano A.D., Roguski K.M., Chang H.H., Muscatello D.J., Palekar R., Tempia S., Cohen C., Gran J.M., Schanzer D., Cowling B.J., Wu P., Kyncl J., Ang L.W., Park M., Redlberger-Fritz M., Yu H., Espenhain L., Krishnan A., Emukule G., van Asten L., Pereira da Silva S., Aungkulanon S., Buchholz U., Widdowson M.A., Bresee J.S.; Global Seasonal Influenza-associated Mortality Collaborator Network. Estimates of global seasonal influenza-associated respiratory mortality: a modelling study. Lancet, 2018, vol. 391, no. 10127, pp. 1285–1300. doi: 10.1016/S0140-6736(17)33293-2
- Izurieta H.S., Thompson W.W., Kramarz P., Shay D.K., Davis R.L., DeStefano F., Black S., Shinefield H., Fukuda K. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N. Engl. J. Med., 2000, vol. 342, no. 4, pp. 232–239. doi: 10.1056/NEJM200001273420402
- Kumar D., Ferreira V.H., Blumberg E., Silveira F., Cordero E., Perez-Romero P., Aydillo T., Danziger-Isakov L., Limaye A.P., Carratala J., Munoz P., Montejo M., Lopez-Medrano F., Farinas M.C., Gavalda J., Moreno A., Levi M., Fortun J., Torre-Cisneros J., Englund J.A., Natori Y., Husain S., Reid G., Sharma T.S., Humar A. A 5-year prospective multicenter evaluation of influenza infection in transplant recipients. Clin. Infect. Dis., 2018, vol. 67, no. 9, pp. 1322–1329. doi: 10.1093/cid/ciy294
- Kumar D., Michaels M.G., Morris M.I., Green M., Avery R.K., Liu C., Danziger-Isakov L., Stosor V., Estabrook M., Gantt S., Marr K.A., Martin S., Silveira F.P., Razonable R.R., Allen U.D., Levi M.E., Lyon G.M., Bell L.E., Huprikar S., Patel G., Gregg K.S., Pursell K., Helmersen D., Julian K.G., Shiley K., Bono B., Dharnidharka V.R., Alavi G., Kalpoe J.S., Shoham S., Reid G.E., Humar A.; American Society of Transplantation H1N1 Collaborative Study Group. Outcomes from pandemic influenza A H1N1 infection in recipients of solid-organ transplants: a multicentre cohort study. Lancet Infect. Dis., 2010, vol. 10, no. 8, pp. 521–526. doi: 10.1016/S1473-3099(10)70133-X
- Manuel O., Estabrook M.; American Society of Transplantation Infectious Diseases Community of Practice. RNA respiratory viral infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin. Transplant., 2019, vol. 33, no. 9: e13511. doi: 10.1111/ctr.13511
- Miskulin D.C., Weiner D.E., Tighiouart H., Lacson E.K. Jr., Meyer K.B., Dad T., Manley H.J. High-dose seasonal influenza vaccine in patients undergoing dialysis. Clin. J. Am. Soc. Nephrol., 2018, vol. 13, no. 11, pp. 1703–1711. doi: 10.2215/CJN.03390318
- Mombelli M., Neofytos D., Huynh-Do U., Sánchez-Céspedes J., Stampf S., Golshayan D., Dahdal S., Stirnimann G., Schnyder A., Garzoni C., Venzin R.M., Magenta L., Schönenberger M., Walti L., Hirzel C., Munting A., Dickenmann M., Koller M., Aubert J.D., Steiger J., Pascual M., Mueller T.F., Schuurmans M., Berger C., Binet I., Villard J., Mueller N.J., Egli A., Cordero E., van Delden C., Manuel O. Immunogenicity of high-dose versus MF59-adjuvanted versus standard influenza vaccine in solid organ transplant recipients: the swiss/spanish trial in solid organ transplantation on prevention of influenza (STOP-FLU Trial). Clin. Infect. Dis., 2024, vol. 78, no. 1, pp. 48–56. doi: 10.1093/cid/ciad477
- Mombelli M., Rettby N., Perreau M., Pascual M., Pantaleo G., Manuel O. Immunogenicity and safety of double versus standard dose of the seasonal influenza vaccine in solid-organ transplant recipients: a randomized controlled trial. Vaccine, 2018, vol. 36, no. 41, pp. 6163–6169. doi: 10.1016/j.vaccine.2018.08.057
- Natori Y., Shiotsuka M., Slomovic J., Hoschler K., Ferreira V., Ashton P., Rotstein C., Lilly L., Schiff J., Singer L., Humar A., Kumar D. A double-blind, randomized trial of high-dose vs standard-dose influenza vaccine in adult solid-organ transplant recipients. Clin.Infect. Dis., 2018, vol. 66, no. 11, pp. 1698–1704. doi: 10.1093/cid/cix1082
- Paget J., Caini S., Del Riccio M., van Waarden W., Meijer A. Has influenza B/Yamagata become extinct and what implications might this have for quadrivalent influenza vaccines? Euro Surveill., 2022, vol. 27, no. 39: 2200753. doi: 10.2807/1560-7917.ES.2022.27.39.2200753
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