Subjects received the trivalent inactivated influenza vaccine (Flubio?, Biofarma, Bandung) or placebo (NaCl 0.9% solution) at the study initiation visit (month 0), THZ531 with a supply of either Lacidofil? (R0052 and R0011) or placebo. as it belongs to the Minister of Health of Republic of Indonesia (Direction No. 657/MENKES/PER/VIII/2009). For data access requests, please contact Dr. Arianti Noor (email: moc.liamg@9181roonitnaira), affiliated with the Dept. Allergy of Immunology, Faculty of Medicine, University or college of Indonesia/Dr. Cipto Mangunkusumo National General Hospital. Abstract Aim To investigate the effect of influenza vaccination with or without Rabbit Polyclonal to HUCE1 probiotic supplementation around the immune response and incidence of influenza-like illness (ILI) in the elderly. Methods A randomized double-blind, placebo-controlled trial with a altered factorial design was conducted in 554 healthy elderly subjects aged 67 5.6 (ranging from 60C90) 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 product (R0052 and R0011) or a placebo for 6 months. Subjects were randomly assigned THZ531 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 end result was ILI incidence within 6 months. The secondary outcomes were seroprotection and seroconversion rates at 1, 4, and 6 months after administering the interventions. THZ531 Results This study showed that this trivalent influenza vaccine increased seroprotection (RR 3.6 [95%CI 2.92C4.47]; p 0.010) and seroconversion (RR 29.8 [95%CI 11.1C79.5]; p 0.010) rates 1 month after vaccination in elderly people while the probiotic product did not alter influenza antibody titers (p = 1.000 and p = 0.210). The relative ILI incidence risk was comparable 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 pattern towards a reduction of ILI incidence with probiotics supplementation warrants further assessments in a larger, at-risk populace. Clinical trial registry number “type”:”clinical-trial”,”attrs”:”text”:”NCT03695432″,”term_id”:”NCT03695432″NCT03695432. Introduction Influenza is usually a major cause of mortality and morbidity worldwide [1]. Indeed, influenza viruses can cause only minimal symptoms, but also can lead to severe and lethal complications [2]. In general, influenza virus infections result in (ARI). However, because ARI symptoms can also be caused by other infectious agents and are not specific to influenza viruses, this set of symptoms is referred to as Influenza-Like Illness (ILI) [3, 4]. In Indonesia, there is currently no available statement around the prevalence of this disease. Based on symptoms used to define ARIs, prevalence is usually estimated at 25% [5]. Numerous studies have shown that influenza viruses and Respiratory Syncytial Computer virus (RSV) are often associated with acute respiratory disease requiring hospitalization, especially in the elderly populace and patients with previous chronic disease [1, 6]. This is why individuals aged 65 years or older are considered among the most vulnerable groups, representing 90% of the reported cases of influenza-related complications. Vaccination is considered as a primary preventive method in the management of influenza [7]. The efficacy of a vaccine at preventing disease can be inferred based on its efficacy and effectiveness at inducing seroconversion, conferring seroprotection, and reducing ILI incidence [8]. However, clinical studies around the effectiveness and efficacy of influenza vaccines in elderly populations have generated contradictory results [9]. Immunosenescence, which refers to the process of immune system aging that is reflected by an increased incidence of infections in the elderly, has been proposed as the cause underlying the reduced immunization response to vaccines observed in the elderly populace. A new strategy is needed to improve the effectiveness of influenza vaccines in the elderly, either by improving the individuals immune response or vaccine formulations [10]. In this study, we explore whether probiotics can improve the immune response triggered by a trivalent influenza vaccine in the elderly, and reduce the incidence of ILI in this population. Materials and methods This study was a randomized, double-blind, placebo-controlled trial with a factorial design comparing the efficacy of two interventions, influenza vaccines and probiotics, at decreasing the risk of ILI in the elderly. The process of the scholarly research was accepted by the study Ethics Panel from the Faculty of Open public Wellness, College or university of Indonesia. The analysis protocol continues to be registered in the Clinicaltrials also.gov Registry, using the clinical trial registry amount “type”:”clinical-trial”,”attrs”:”text”:”NCT03695432″,”term_id”:”NCT03695432″NCT03695432. There is a non-trial-related specialized concern leading to the hold off in registering the scholarly research, that it had been performed following the subject enrollment started afterwards. Eligible participants had been randomized into four involvement groupings: influenza vaccine + probiotics; influenza vaccine + placebo; placebo + probiotics; and both placebo. This scholarly research was executed in the complete Pulo Gadung Region, East Jakarta, between and Dec 2015 Apr, which was the time encompassing flu period. At the start of the intensive analysis,.
