A multicenter, randomized, double-blind, placebo-controlled trial of influenza immunization in multiple sclerosis

Abstract

We determined the effect of influenza vaccine in patients with relapsing/remitting MS. Considerable controversy surrounds the question of whether to administer influenza vaccines to MS patients. Prevention of a febrile viral illness is clearly desirable in MS, and previous studies suggest that immunization is safe. Despite this, many clinicians avoid vaccination because they fear precipitating an MS exacerbation. We conducted a multicenter, prospective, randomized, double-blind trial of influenza immunization in patients with relapsing/remitting MS. In the autumn of 1993, 104 patients at five MS centers received either standard influenza vaccine or placebo. Patients were followed for 6 months for evaluation of neurologic status and the occurrence of influenza. Influenza was operationally defined as fever > or = 38 degrees C in the presence of coryza, cough, or sore throat at a time when the disease was present in the community. Attacks were defined in the standard manner, requiring objective change in the examination. Patients were examined at 4 weeks and 6 months after inoculation and were contacted by telephone at 1 week and 3 months. They were also examined at times of possible attacks but not when they were sick with flu-like illness. Three vaccine patients and two placebo patients experienced attacks within 28 days of vaccine (no significant difference). Exacerbation rates in the first month for both groups were equal to or less than expected from published series. The two groups showed no difference in attack rate or disease progression over 6 months. Influenza immunization in MS patients is neither associated with an increased exacerbation rate in the postvaccination period nor a change in disease course over the subsequent 6 months.

Vitamin D and autoimmune thyroid diseases

“…In addition, several studies demonstrated genetic polymorphism of the vitamin D-binding protein among Polish 49 and Japanese 50 patients with AITDs, whereas the CYP27B1 hydroxylase polymorphism was found to predispose to Hashimoto's thyroiditis and Graves' disease in German subjects. 51 Of note, some of these associations could not be confirmed in other studies. 52 The present study has several limitations, including the small number of patients, the heterogeneity of the study population, and lack of information on nutrition, social behavior (e.g., outdoor activity) and concomitant diseases.…”

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

“…For example, speculation existed about hepatitis B vaccination causing or triggering relapses of multiple sclerosis (MS) based on case reports. The rate of MS in the United States is estimated at 109 cases per 100,000 persons [24], and the onset or exacerbation of disease after vaccination appears to be coincidental as the increasingly large body of epidemiological evidence reveals no increased rate of MS onset or relapse after receipt of any licensed vaccine [25][26][27]. The modified WHO criteria used in this review addressed the epidemiologic evidence for causal assessment, thus taking into account whether an event occurred at a greater rate than the background incidence.…”

Safety and Utilization of Influenza Immunization in Children With Inflammatory Bowel Disease

“…24,28 However, these were underpowered to demonstrate rare events, nor did they document less serious events that may have prompted outpatient physician visits. Randomized controlled trials and observational studies in multiple sclerosis 29,30 and rheumatoid arthritis 31 also did not demonstrate increased risk of disease flare after immunization. The primary advantage of the current study is its large numbers of included children with IBD and its ability to assess the full spectrum of health system utilization.…”