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B/Austria/1359417/2021-Like Strain (B/Singapore/Wuh4618/2021)

This article discusses a clinical trial investigating the long-term safety, tolerability, and effectiveness of ofatumumab in patients with relapsing multiple sclerosis (RMS). The study is an open-label, single-arm, multi-center extension trial that aims to evaluate the drug’s performance over an extended period. While the main focus is on ofatumumab, the trial also includes information about a flu vaccine containing the B/Austria/1359417/2021-Like Strain (B/Singapore/Wuh4618/2021).

Table of Contents

What is B/AUSTRIA/1359417/2021-LIKE STRAIN?

B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021) is a component of the influenza vaccine known as Flucelvax Tetra[1]. This strain is a specific type of influenza B virus that has been selected for inclusion in the vaccine based on recommendations from health authorities. It is important to note that this strain is part of a vaccine and not a standalone medication.

Vaccine Composition

Flucelvax Tetra is a quadrivalent influenza vaccine, which means it contains four different strains of influenza virus[1]. The vaccine includes:

  • B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021)
  • B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE)
  • A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE)
  • A/WISCONSIN/67/2022 (H1N1)PDM09-LIKE STRAIN (A/GEORGIA/12/2022 CVR-167)

These strains are carefully selected each year based on global surveillance of circulating influenza viruses to provide the best possible protection against seasonal flu[1].

Medical Use

Flucelvax Tetra, which contains the B/AUSTRIA/1359417/2021-LIKE STRAIN, is used to prevent influenza, commonly known as “the flu”[1]. Influenza is a highly contagious respiratory illness that can cause mild to severe symptoms and, in some cases, lead to hospitalization or even death, especially in high-risk groups.

The vaccine works by stimulating the body’s immune system to produce antibodies against the included virus strains. This helps the body recognize and fight off these specific influenza viruses if exposed to them later[1].

Administration

Flucelvax Tetra is administered as an intramuscular injection[1]. The vaccine comes in a pre-filled syringe containing a suspension for injection. The typical dose is 0.5 ml, which contains all four virus strains, including the B/AUSTRIA/1359417/2021-LIKE STRAIN[1].

It’s important to note that this vaccine is typically given once per flu season. However, the exact dosing schedule may vary depending on factors such as age and previous flu vaccination history. Always follow the recommendations of your healthcare provider[1].

Safety and Effectiveness

The safety and effectiveness of influenza vaccines, including those containing the B/AUSTRIA/1359417/2021-LIKE STRAIN, are closely monitored by health authorities. These vaccines undergo rigorous testing before approval and continued surveillance after they are in use[1].

Like all vaccines, Flucelvax Tetra can cause side effects, although not everyone experiences them. Common side effects may include pain at the injection site, headache, fatigue, and muscle aches. These are usually mild and resolve on their own within a few days[1].

It’s important to remember that the benefits of vaccination in preventing influenza and its complications generally outweigh the potential risks of side effects for most people. However, if you have concerns about the vaccine, you should discuss them with your healthcare provider[1].

In conclusion, the B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021) is an important component of the Flucelvax Tetra influenza vaccine, designed to provide protection against a specific strain of influenza B virus. As part of a quadrivalent vaccine, it contributes to broader protection against seasonal influenza[1].

Aspect Details
Study Type Open-label, single arm, multi-center extension study
Main Objective Evaluate long-term safety and tolerability of ofatumumab in RMS patients
Secondary Objectives Describe long-term efficacy, compare outcomes with immediate vs delayed treatment, explore health outcomes
Key Inclusion Criteria Previous participation in Novartis MS study with ofatumumab, completed on study treatment
Key Exclusion Criteria Premature discontinuation, >6 months since previous study, active infections, PML
Primary Endpoints Adverse events, abnormal lab results, ECG findings, C-SSRS criteria
Secondary Endpoints ARR, time to relapse, disability progression/improvement, MRI findings, NfL levels
Treatment Ofatumumab 20 mg subcutaneous injection every 4 weeks
Study Duration Through Week 240 (End of Study)

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the long-term safety and tolerability of ofatumumab 20 mg subcutaneous injection once every 4 weeks in subjects with relapsing multiple sclerosis (RMS).
  • Who can participate in this clinical trial? Participants must have previously been involved in a Novartis MS study that dosed ofatumumab 20 mg subcutaneously every 4 weeks, was an adult (≥ 18 years of age) study in RMS, and must have completed the study on study treatment. They also need to provide written informed consent.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include premature discontinuation from a previous ofatumumab study, having the previous study end more than 6 months prior to screening, active systemic infections, and neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML).
  • What are the primary endpoints of the study? The primary endpoints include the proportion of subjects with adverse events, abnormal laboratory or vital signs results, abnormal electrocardiogram (ECG) findings, and those meeting predefined criteria in the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Is there any information about flu vaccines in this trial? Yes, the trial mentions a flu vaccine called Flucelvax Tetra, which contains the B/Austria/1359417/2021-Like Strain (B/Singapore/Wuh4618/2021) among other strains. This vaccine is not the main focus of the study but is included in the trial information.

Ongoing Clinical Trials on B/Austria/1359417/2021-Like Strain (B/Singapore/Wuh4618/2021)

  • Study of Influenza Vaccine Effects on Immune Response in the Nose and Airways in Adults Seeking Protection Against Seasonal Flu

    Not recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +15

Glossary

  • Relapsing Multiple Sclerosis (RMS): A form of multiple sclerosis characterized by clearly defined attacks of new or increasing neurologic symptoms, followed by periods of partial or complete recovery (remissions).
  • Ofatumumab: A medication used to treat relapsing forms of multiple sclerosis in adults. It is administered as a subcutaneous injection.
  • Subcutaneous (sc): A route of administration where a medication is injected into the layer of tissue between the skin and the muscle.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Annualized Relapse Rate (ARR): A measure used in multiple sclerosis research to quantify the number of relapses a patient experiences per year.
  • Expanded Disability Status Scale (EDSS): A method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time.
  • Magnetic Resonance Imaging (MRI): A medical imaging technique used to produce detailed images of the body's organs and tissues, particularly useful in diagnosing and monitoring multiple sclerosis.
  • Neurofilament light chain (NfL): A protein released into the cerebrospinal fluid and blood when neurons are damaged, used as a biomarker in multiple sclerosis.
  • Progressive Multifocal Leukoencephalopathy (PML): A rare and serious brain infection caused by the John Cunningham (JC) virus, which can occur in some patients with weakened immune systems.
  • Teriflunomide: An oral medication used to treat relapsing forms of multiple sclerosis.

References

  1. http://clinicaltrials.eu/trial/study-on-long-term-safety-and-effectiveness-of-ofatumumab-for-patients-with-relapsing-multiple-sclerosis/