Tetanus, diphtheria, and acellular pertussis vaccine for Multiple Sclerosis, Acute Relapsing

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Universitaetsklinikum Jena, Jena, Germany
Multiple Sclerosis, Acute Relapsing+2 More
Tetanus, diphtheria, and acellular pertussis vaccine - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy

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Eligible Conditions

  • Multiple Sclerosis, Acute Relapsing
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Tetanus, diphtheria, and acellular pertussis vaccine will improve 1 primary outcome and 3 secondary outcomes in patients with Multiple Sclerosis, Acute Relapsing. Measurement will happen over the course of At Day 28.

At Day 28
Pneumococcus
Proportion of participants with serologic response to tetanus toxoid
Safety of concomitant vaccine administration in participants taking ozanimod
Tetanus

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

Cohort 1 - non-pegylated interferon-β or no disease modifying therapy
1 of 4
Cohort 1 - Ozanimod
1 of 4
Cohort 2 - Ozanimod
1 of 4
Cohort 2 - non-pegylated interferon-β or no disease modifying therapy
1 of 4
Experimental Treatment

This trial requires 60 total participants across 4 different treatment groups

This trial involves 4 different treatments. Tetanus, Diphtheria, And Acellular Pertussis Vaccine is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Cohort 1 - non-pegylated interferon-β or no disease modifying therapyComprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), Pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine.
Cohort 1 - OzanimodComprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), pneumococcal polysaccharide vaccine (PPSV23), and the seasonal inactivated influenza vaccine.
Cohort 2 - OzanimodComprises of participants received oral ozanimod will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap), and pneumococcal polysaccharide vaccine (PPSV23).
Cohort 2 - non-pegylated interferon-β or no disease modifying therapyComprises of participants received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) will be administered tetanus, diphtheria, and acellular pertussis vaccine (Tdap) and Pneumococcal polysaccharide vaccine (PPSV23).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumococcal polysaccharide vaccine
2008
Completed Phase 4
~450
Seasonal influenza vaccine
2010
Completed Phase 3
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at day 28
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at day 28 for reporting.

Closest Location

Michigan State University MS Clinic - East Lansing, MI

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Multiple Sclerosis, Acute Relapsing or one of the other 2 conditions listed above. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant has a diagnosis of multiple sclerosis (MS) according to the 2017 revision of the McDonald diagnostic criteria and has relapsing forms of multiple sclerosis (RMS): relapsing-remitting MS (RRMS) or secondary progressive MS with active disease based on recent clinical relapse or MRI lesion activity.

Patient Q&A Section

What is the average age someone gets sclerosis?

"There is an increase in the risk of developing sclerosis with age. This is particularly prevalent before age 60, which may be due to genetic factors.\n\nAtaxia is a neurologic disorder where the limbs that control movements become unstable, and the patient has difficulty balancing and maintaining a stable position. One’s unsteady stance becomes worse over time as the muscles involved in gait are progressively harmed.\n\nAtaxia may lead to an unsteady and inefficient gait." - Anonymous Online Contributor

Unverified Answer

What is sclerosis?

"Sclerosis refers to the stiffening of a bone or part thereof such as a bone in the wrist or shoulder. It is typically found in the bones of the lower extremities in people in their seventies and eighties. It may cause difficulty with motion. Diagnosing sclerosis is important because a lack of treatment may lead to pain, deformity and eventual fracture.\n\nThis list is an extension of the list of conditions for which ICD-10 codes are provided." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sclerosis?

"Treatment for sclerosis is highly varied. Physical therapy and/or massage are typically the preferred treatments. Surgery and drugs may be used if appropriate. As a last resort, most patients seek medical attention for their condition." - Anonymous Online Contributor

Unverified Answer

How many people get sclerosis a year in the United States?

"Approximately 453,900 new cases are diagnosed each year by primary care physicians. Of those patients, an estimated 24% and 2980 die from SSc at 5 and 10 years respectively." - Anonymous Online Contributor

Unverified Answer

Can sclerosis be cured?

"Sclerosing cholangitis has a favourable outcome with medical or surgical therapy. Patients treated surgically have a high survival rate. The long-term prognosis for patients with progressive sclerosis is poor, although there is some chance of being alive after 15 years." - Anonymous Online Contributor

Unverified Answer

What causes sclerosis?

"Even if the precise cause of sclerosis is unknown many different theories exist. A wide variety of pathological conditions can cause sclerosis, such as an infection, cancer, autoimmune disease, trauma to the nerve root, or a hereditary or genetic disorder. More information is needed to find a definite answer to the cause of sclerosis, the optimal treatment, and the expected prognosis." - Anonymous Online Contributor

Unverified Answer

What are the signs of sclerosis?

"Sclerotic changes were seen in the lung on CT in all patients with SSc. These changes seem to be the result of the action of systemic sclerosis, since they also were present in patients with other forms of SSc who had never acted, nor been exposed to, scleroderma in their lifetimes. These CT signs cannot be classified as lung scleroses after the definition of the terminology proposed by the International Consensus Workshop on Scleroderma. They are not the histological equivalents of the histological forms that are characteristic of scleroderma." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in tetanus, diphtheria, and acellular pertussis vaccine for therapeutic use?

"As vaccines to prevent tetanus, diphtheria, and acellular pertussis are needed because there is no available vaccine as of today. Tetanus, diphtheria, and acellular pertussis vaccinations could be used in addition to tuberculosis prophylaxis as these vaccinations can be given to patients who have high-priority indications for immunoglobulin prophylaxis against tuberculosis, and in our opinion to treat these disease. The tetanus, diphtheria, and acellular pertussis vaccines must not be given with any anti-tuberculosis drugs. For therapeutic use, these vaccines should be given separately from tuberculosis prophylaxis." - Anonymous Online Contributor

Unverified Answer

Is tetanus, diphtheria, and acellular pertussis vaccine safe for people?

"Tetanus, DPT and acellular pertussis vaccines can be administered safely and effectively to people with SCI. The benefits of immunization outweighed the risks to people with SCI and there was minimal risk to healthy infants." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sclerosis?

"The primary cause responsible for FSGS is the immune-mediated disease process, most often a systemic disease, such as multiple sclerosis (MS), SLE, or rheumatoid arthritis (RA), a systemic vasculitic disease process, such as polymyalgia rheumatica (PMR), and renal vascular disease caused by systemic hypertension." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating sclerosis?

"The main goal is to create a new therapeutic approach for patients with SSc. There are several possibilities of using the cell and molecular biological effects. It will be better to try new approaches on different people before they take a definite place in medicine." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for sclerosis?

"No differences in patient outcomes were found between participants with or without systemic sclerosis. Because systemic sclerosis has little influence on our outcomes, these findings are suggestive that clinical trials for these conditions are unlikely to yield valuable information. The study design did not allow for the consideration of the duration of scleroderma. If clinical trials are performed in this disease, it will be very important to have long-term follow-up to compare outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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