A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

What Was Tested

The trial (phase 4) is built around Glatiramer Acetate for multiple sclerosis.

It had six arms (groups): Cohort 1 - 2 WKs vaccine prior to OMB157 (experimental), Cohort 2 - vaccine 4 WKs after OMB157 (experimental), Cohort 3 - Interferon or glatiramer acetate - vaccine 4 WKs after (active comparator), Cohort 4 - Fully vaccinated and on OMB457 ≥ 4 WKs (experimental) and Cohort 5 -Fully vaccinated, on interferon or glatiramer acetate for ≥ 4 WKs ± booster (experimental).

Participants will receive non-live COVID-19 mRNA vaccine at least 4 weeks after start of prescribed interferon or glatiramer acetate.

The registry classes the interventions as biological and drug.

More on the Plan

This was a six-cohort, multicenter, prospective study planned for up to 88 relapsing multiple sclerosis (MS) participants.

Cohort 1: participants received an mRNA COVID-19 vaccine at least two weeks prior to ofatumumab start.

Cohort 2: participants received an mRNA COVID-19 vaccine at least four weeks after beginning ofatumumab.

Cohort 3: participants on an interferon or glatiramer acetate who received COVID-19 mRNA vaccine.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent must be obtained prior to participation in the study. Diagnosis of relapsing MS by 2017 revised McDonald criteria. Were willing to comply with the study schedule.

The full record lists 9 inclusion and 4 exclusion criteria; among the exclusions: received the j\&j vaccine; had a contraindication to receiving an mrna covid-19 vaccine; had an immediate allergic reaction to past vaccine or injection.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2021-06-10 with completion listed for 2023-04-14.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Response by SARS-CoV-2 Qualitative IgG Antibody Assay at 14 Days Post-vaccination by Cohort Group and Overall, Non-response Imputation Approach (Safety Analysis Set).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Glatiramer Acetate in 24 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.