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Koesnoe S., Masjkuri N., Adisasmita A., Djauzi S., Kartasasmita C., Sundoro J., Nadjib M., Korib M., Muthia A.N., Muzellina V.N., Habibah U., Nursyirwan S.A., Djaya K.H., Bachtiar N.S., Sari R.M. |
26028015000;57189271669;22978283200;23495847800;57206248946;49762130000;24401623600;57391576000;57391576100;57223968527;57391443900;57249143800;57392218600;54879388400;57191341371; |
A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia |
2021 |
PLoS ONE |
16 |
12 December |
e0250234 |
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https://www.scopus.com/inward/record.uri?eid=2-s2.0-85122024701&doi=10.1371%2fjournal.pone.0250234&partnerID=40&md5=6918933f17507c8ed64013b241adb3c2 |
Division of Allergy and Immunology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia; Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; Department of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia; Department of Child Health, Faculty of Medicine, Padjadjaran University, Hasan Sadikin General Hospital, Bandung, Indonesia; Indonesian Technical Advisory Group on Immunization, Jakarta, Indonesia; Department of Health Policy and Administration, Faculty of Public Health University of Indonesia, Jakarta, Indonesia; Indonesian Society of Internal Medicine, Jakarta, Indonesia; Division of Gastroenterology, Depertment of Internal Medicine, dr. Cipto Mangunkusomo Hospital, Jakarta, Indonesia; Division of Gastroenterology, Depertment of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; PT. Bio Farma, Bandung, Indonesia |
Koesnoe, S., Division of Allergy and Immunology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; Masjkuri, N., Department of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia; Adisasmita, A., Department of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia; Djauzi, S., Division of Allergy and Immunology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia, Division of Allergy and Immunology, Department of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; Kartasasmita, C., Department of Child Health, Faculty of Medicine, Padjadjaran University, Hasan Sadikin General Hospital, Bandung, Indonesia; Sundoro, J., Indonesian Technical Advisory Group on Immunization, Jakarta, Indonesia; Nadjib, M., Department of Health Policy and Administration, Faculty of Public Health University of Indonesia, Jakarta, Indonesia; Korib, M., Department of Epidemiology, Faculty of Public Health University of Indonesia Jakarta, Jakarta, Indonesia; Muthia, A.N., Indonesian Society of Internal Medicine, Jakarta, Indonesia; Muzellina, V.N., Division of Gastroenterology, Depertment of Internal Medicine, dr. Cipto Mangunkusomo Hospital, Jakarta, Indonesia, Division of Gastroenterology, Depertment of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; Habibah, U., Indonesian Society of Internal Medicine, Jakarta, Indonesia; Nursyirwan, S.A., Division of Gastroenterology, Depertment of Internal Medicine, dr. Cipto Mangunkusomo Hospital, Jakarta, Indonesia, Division of Gastroenterology, Depertment of Internal Medicine, Faculty of Medicine University of Indonesia, Jakarta, Indonesia; Djaya, K.H., Indonesian Society of Internal Medicine, Jakarta, Indonesia; Bachtiar, N.S., PT. Bio Farma, Bandung, Indonesia; Sari, R.M., PT. Bio Farma, Bandung, Indonesia |
Aim To investigate the effect of influenza vaccination with or without probiotic supplementation on the immune response and incidence of influenza-like illness (ILI) in the elderly. Methods A randomized double-blind, placebo-controlled trial with a modified factorial design was conducted in 554 healthy elderly subjects aged 67 ± 5.6 (ranging from 60–90) years old in the Primary Health Care Center (Puskesmas area) of the Pulo Gadung District East Jakarta. Subjects received either a trivalent influenza vaccine or placebo at the start of the study, and a probiotic supplement (Lactobacillus helveticus R0052 and Lactobacillus rhamnosus R0011) or a placebo for 6 months. Subjects were randomly assigned into four intervention groups: influenza vaccine and probiotics (n = 141), influenza vaccine and placebo (n = 136), placebo and probiotics (n = 140), and both placebo (n = 137). The primary outcome was ILI incidence within 6 months. The secondary outcomes were seroprotection and seroconversion rates at 1, 4, and 6 months after administering the interventions. Results This study showed that the trivalent influenza vaccine increased seroprotection (RR 3.6 [95%CI 2.92–4.47]; p<0.010) and seroconversion (RR 29.8 [95%CI 11.1–79.5]; p<0.010) rates 1 month after vaccination in elderly people while the probiotic supplement did not alter influenza antibody titers (p = 1.000 and p = 0.210). The relative ILI incidence risk was similar between vaccinated and non-vaccinated groups, as well as in the probiotic group compared to the non-probiotic group. Conclusion The tested trivalent influenza vaccine significantly induced seroprotection and seroconversion in the vaccinated subjects, while probiotics administration did not influence these parameters. Vaccinated individuals displayed a similarly low ILI incidence as those in the Control Group. However, the observed trend towards a reduction of ILI incidence with probiotics supplementation warrants further assessments in a larger, at-risk population. © 2021 Koesnoe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
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flubio; influenza vaccine; placebo; influenza vaccine; probiotic agent; adult; aged; antibody titer; Article; controlled study; diet supplementation; double blind procedure; drug effect; female; human; immune response; incidence; Indonesia; influenza; major clinical study; male; middle aged; population risk; population structure; primary health care; randomized controlled trial; sample size; seroconversion; treatment duration; treatment outcome; vaccination; very elderly; incidence; influenza; Lactobacillus helveticus; Lactobacillus rhamnosus; Aged; Aged, 80 and over; Double-Blind Method; Female; Humans; Incidence; Indonesia; Influenza Vaccines; Influenza, Human; Lactobacillus helveticus; Lactobacillus rhamnosus; Male; Middle Aged; Probiotics |
Public Library of Science |
19326203 |
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34914726 |
Article |
Q1 |
990 |
4434 |
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