Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients

NCT05286242 | Active Not Recruiting

• 3 other identifiers: 20000298892U19AI089992-112U19AI089992-06A1
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the immune response to coronavirus disease-19 (COVID-19) vaccination in patients on B-cell depleting therapies (BCDT) over time, which in the future may help to inform clinical decision making in this patient population.

Conditions

Multiple Sclerosis; Autoimmune Blistering Disease; B-Cell Deficiency

Outcome Measures

Primary Outcomes (2)

• Change in coronavirus disease 19 (COVID19) antibody titers over time

  COVID 19 spike and neutralizing antibody titers will be monitored serially

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

• Change in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific T-cell activation over time

  Flow cytometry characterizing immunophenotype of SARS-CoV2 specific T cells

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

Secondary Outcomes (6)

• Skin biopsy analysis

  7 days post vaccine 1; 7 days post vaccine 2; 4 days post booster (all timepoints optional)

• Measurement of COVID19 antibodies in saliva

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

• Immune analysis

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

• Changes in patient reported outcomes: COVID history

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

• Change in patient reported outcomes: patient reported disability steps

  Baseline, 2 weeks post vaccine 1, pre-vaccine 2, 1 week post vaccine 2, 6 months post vaccine 2; pre- and 2 week post any additional vaccines

Study Arms (4)

Healthy control

Healthy controls Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.

Biological: COVID19 vaccine

Disease control

Disease controls (individuals with a qualifying autoimmune condition, but not treated with any immunomodulator). Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.

Biological: COVID19 vaccine

B-cell depleted

Individuals with autoimmune disease (multiple sclerosis or autoimmune blistering disease) who are treated with B-cell depleting anti-CD20 monoclonal antibodies. Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.

Biological: COVID19 vaccine

Other immunomodulator

Individuals with autoimmune disease (multiple sclerosis or autoimmune blistering disease) who are treated with a non-CD20 monoclonal antibody immunomodulator to treat their disease. Participants will receive COVID19 vaccination according to standard of care (any FDA approved vaccine). They will donate serial biospecimens before and after vaccination according to the study design.

Biological: COVID19 vaccine

Interventions

COVID19 vaccine BIOLOGICAL

All participants receive one or more FDA-authorized COVID19 vaccinations according to standard of care and current medical recommendations. The intervention is not specifically administered as part of the study.

B-cell depleted; Disease control; Healthy control; Other immunomodulator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There will be four groups of participants overall: * Patients with autoimmune neurologic/autoimmune blistering disease (AIBD) who are on B-cell depleting therapy (anti-CD20 monoclonal antibodies) * Patients with autoimmune neurologic/AIBD who are on other types of immunomodulators * Patients with autoimmune neurologic/AIBD who are untreated * Healthy controls

You may not qualify if:

• Use of high dose steroids for treatment of neurologic/immunologic disease within 1 month of COVID-19 vaccination
• Anti-CD20 B-cell depleting therapy infused within 2 weeks of first study visit
• Inability to comply with the requirements of the protocol, in the opinion of the primary investigator

Sponsors & Collaborators

• Yale University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Robert Leet and Clara Guthrie Patterson Trust: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells (PBMC), DNA, skin biopsies, saliva

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Erin Longbrake

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 18, 2022
• Study Start: February 10, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (1)