Abstract
AimTo 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.MethodsA 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.ResultsThis 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.ConclusionThe 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.Clinical trial registry numberNCT03695432.
Highlights
Influenza is a major cause of mortality and morbidity worldwide [1]
This study showed that the trivalent influenza vaccine increased seroprotection (RR 3.6 [95%CI 2.92–4.47]; p
The relative Influenza-Like Illness (ILI) incidence risk was similar between vaccinated and non-vaccinated groups, as well as in the probiotic group compared to the non-probiotic group
Summary
Influenza is a major cause of mortality and morbidity worldwide [1]. influenza viruses can cause only minimal symptoms, and can lead to severe and lethal complications [2]. Because ARI symptoms can 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]. Various studies have shown that influenza viruses and Respiratory Syncytial Virus (RSV) are often associated with acute respiratory disease requiring hospitalization, especially in the elderly population 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
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