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B/Phuket/3073/2013-Like Virus (B/Singapore/Inftt-16-0610/2016, Wild Type)

This article discusses clinical trials investigating the use of ofatumumab, a medication for treating relapsing multiple sclerosis (RMS). The trials aim to evaluate the long-term safety, tolerability, and effectiveness of ofatumumab in patients with RMS. These studies are important for understanding how the drug performs over extended periods and its potential benefits for managing this chronic neurological condition.

Table of Contents

What is B/PHUKET/3073/2013-LIKE VIRUS?

B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE) is a specific strain of influenza virus used in the production of influenza vaccines[1]. This virus strain is one of the components in a vaccine called Flucelvax Tetra, which is designed to protect against influenza, commonly known as the flu.

Vaccine Composition

Flucelvax Tetra is a quadrivalent influenza vaccine, which means it contains four different strains of influenza virus to provide broad protection against various flu types. The vaccine includes the following components[1]:

  • B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE)
  • B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021)
  • 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)

Each of these components represents a different strain of influenza virus, helping to protect against multiple types of flu that may circulate in a given season.

Medical Use

Flucelvax Tetra, which contains the B/PHUKET/3073/2013-LIKE VIRUS, is used for the prevention of influenza[1]. Influenza is a contagious respiratory illness that can cause mild to severe illness, and in some cases, can lead to hospitalization or even death, especially in high-risk groups such as young children, older adults, and people with certain health conditions.

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

Administration

Flucelvax Tetra is administered as an intramuscular injection[1]. This means the vaccine is injected directly into a muscle, typically in the upper arm for adults and older children, or the thigh for infants.

The vaccine is provided as a suspension for injection in a pre-filled syringe[1]. The typical dose is 0.5 ml, which contains all four virus strains, including the B/PHUKET/3073/2013-LIKE VIRUS.

Synonyms

The B/PHUKET/3073/2013-LIKE VIRUS is also known by the following synonym[1]:

  • B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)

This alternative name may be used in scientific literature or other vaccine descriptions, but they refer to the same virus strain used in the Flucelvax Tetra vaccine.

Aspect Details
Study Type Open-label, single arm, multi-center extension study
Primary Objective Evaluate long-term safety and tolerability of ofatumumab
Secondary Objectives Describe long-term efficacy, compare outcomes, explore health outcomes
Inclusion Criteria Previous participation in Novartis MS study with ofatumumab, adults with RMS
Exclusion Criteria Premature discontinuation, active infections, PML
Primary Endpoints Adverse events, laboratory results, ECG, suicide risk assessment
Secondary Endpoints Relapse rate, disability progression, MRI measures, brain volume changes
Duration Through Week 240 (End of Study)

FAQ

  • What is the main objective of the clinical trial? The main objective is to evaluate the long-term safety and tolerability of ofatumumab 20 mg administered subcutaneously once every 4 weeks in subjects with relapsing multiple sclerosis (RMS).
  • Who is eligible to participate in this clinical trial? Eligible participants must have previously participated in a Novartis MS study that dosed ofatumumab 20 mg subcutaneously every 4 weeks, was an adult study (18 years or older) in RMS, and must have completed the study on study treatment.
  • What are some of the exclusion criteria for the trial? Some exclusion criteria include premature discontinuation from a previous ofatumumab study, having active systemic bacterial, viral, or fungal infections, and having neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML.
  • What are some of the secondary objectives of the study? Secondary objectives include describing long-term efficacy of ofatumumab, comparing long-term outcomes in immediately treated versus delayed treatment groups, and exploring long-term health outcomes in subjects with RMS treated with ofatumumab.
  • What are some of the endpoints being measured in this trial? The trial measures various endpoints, including the proportion of subjects with adverse events, annualized relapse rate, time to confirmed disability worsening or improvement, changes in brain volume, and patient-reported outcomes.

Ongoing Clinical Trials on B/Phuket/3073/2013-Like Virus (B/Singapore/Inftt-16-0610/2016, Wild Type)

  • 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.
  • Ofatumumab: A medication used to treat relapsing multiple sclerosis, administered subcutaneously (under the skin) once every 4 weeks.
  • Subcutaneous (sc): A route of administration where a drug is injected into the tissue layer between the skin and the muscle.
  • Annualized Relapse Rate (ARR): The average number of relapses a patient with multiple sclerosis 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 brain and spinal cord in multiple sclerosis patients.
  • Neurofilament Light Chain (NfL): A protein released into the blood when nerve cells are damaged, used as a biomarker in multiple sclerosis.
  • Progressive Multifocal Leukoencephalopathy (PML): A rare and serious brain infection that can occur in some patients with weakened immune systems.
  • Disease-Modifying Therapy (DMT): Treatments that can reduce the frequency and severity of multiple sclerosis relapses and slow the progression of the disease.

References

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