A multicenter, prospective cohort study to document the immunization status of MS patients in Germany with focus on anti-SARS-CoV-2 vaccination response (COVID-19)

A multicenter, prospective cohort study to document the immunization status of MS patients in Germany with focus on anti-SARS-CoV-2 vaccination response (COVID-19) - SARS-CoV-2-related MS Vaccination Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025893

Enrollment

200

Registered

2021-07-15

Start date

2021-07-19

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Study visits are performed at baseline (within 90 days prior to vaccination) followed by up to 3 follow-up visits within 6 months after the first documented SARS-COV-2 vaccination. In case f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female patients of at least 18 years of age at time of informed consent 2. Diagnosis of MS according to McDonald criteria (2018) 3. Ability to understand the purpose of the study and provide signed and dated study-specific informed consent form (ICF) 4. SARS-CoV-2 vaccination is planned (within the upcoming 90 days), underway (only one of two vaccinations received) or only recently completed (in the last 6 weeks). or SARS-CoV-2 vaccination has been completed > 6 weeks but an additional vaccination is planned within the upcoming 90 days. 5. In case of prior SARS-CoV-2 infection(s), patient has recovered from infection.

Exclusion criteria

Exclusion criteria: 1. Patient cannot be regularly followed up for organizational or geographic reasons. 2. Patient is unwilling to get vaccinated against SARS COV-2 virus.

Design outcomes

Primary

Measure	Time frame
Number and proportion of patients who developed an immune response to their last SARS-Cov-2-vaccination at visit 2 (about 30 days after the last vaccination)	—

Secondary

Measure	Time frame
Change of SARS-CoV-2 Spike IgA levels, Spike IgG, and NCP IgG levels; Number and proportion of patients who retained an immune response to their last SARS-CoV-2-vaccination at visit 1 (if applicable) and visit 3; Number and proportion of patients who developed an immune response to their SARS-CoV-2-vaccination at visit 1 (if applicable), visit 2 and visit 3 per vaccination cycle ; Number and proportion of patients by applied SARS-CoV-2 vaccine and vaccination cycle; Number and proportion of patients per vaccination cycle; Number and proportion of patients assessing the tolerability of the applied vaccine according to the predefined categories.	—

Measure

Time frame

Change of SARS-CoV-2 Spike IgA levels, Spike IgG, and NCP IgG levels; Number and proportion of patients who retained an immune response to their last SARS-CoV-2-vaccination at visit 1 (if applicable) and visit 3; Number and proportion of patients who developed an immune response to their SARS-CoV-2-vaccination at visit 1 (if applicable), visit 2 and visit 3 per vaccination cycle ; Number and proportion of patients by applied SARS-CoV-2 vaccine and vaccination cycle; Number and proportion of patients per vaccination cycle; Number and proportion of patients assessing the tolerability of the applied vaccine according to the predefined categories.

—

Countries

Germany

Contacts

Public ContactSilke Heeren

CLINVICES GmbH

silke.heeren@clinvices.com+4983314989592

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026