Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 5 May 2025
• Main ID: NCT05286242
• Date of registration: 15/03/2022
• Prospective Registration: No
• Primary sponsor: Yale University
• Public title: Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
• Scientific title: Evaluating the Immune Response to COVID19 Vaccination in Immunodeficient Patients
• Date of first enrolment: February 10, 2021
• Target sample size: 400
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05286242
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Erin Longbrake
• Affiliation: Yale University

Key inclusion & exclusion criteria

Subjects with neurologic/immunologic condition:

- at least 18 years of age

- Known diagnosis of autoimmune neurologic disease (e.g. multiple sclerosis (MS),
neuromyelitis optica, myelin oligodendrocyte glycoprotein (MOG) -associated
disorder) or autoimmune blistering disease (AIBD).

- EITHER:

- Treated with an anti-CD20 (rituximab, ocrelizumab) medications for >6 months at
the time of vaccination (B-cell depletion therapy, BCDT)

- On no immunomodulatory therapy for their autoimmune condition for >6 months at
the time of vaccination

- Treated with a non-BCDT immunotherapy

- No relapse of neurologic/immunologic disease for >6 months prior to the time of
enrollment

- Subject is eligible and willing to receive COVID-19 vaccination in accordance with
local and national guidelines, or subject intends to receive booster COVID-19
vaccination in accordance with recommendations from their primary medical team.

- No active skin condition (e.g. open sores) preventing blood draw

Healthy Controls:

- at least 18 years of age

- No evidence of neurological/immunologic disease/illness/condition

- Subject is eligible and willing to receive COVID-19 vaccination in accordance with
local and national guidelines, or subject intends to receive booster COVID-19
vaccination in accordance with recommendations from their primary medical team.

- No active skin condition (e.g. open sores) preventing blood draw/skin biopsy

Exclusion Criteria:

- 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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Blistering Disease

Multiple Sclerosis

B-Cell Deficiency

Intervention(s)

Biological: COVID19 vaccine

Primary Outcome(s)

Change in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) specific T-cell activation over time [Time Frame: 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 coronavirus disease 19 (COVID19) antibody titers over time [Time Frame: 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 Outcome(s)

Measurement of COVID19 antibodies in saliva [Time Frame: 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 [Time Frame: 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: overall symptoms [Time Frame: 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 [Time Frame: 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 [Time Frame: 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]

Skin biopsy analysis [Time Frame: 7 days post vaccine 1; 7 days post vaccine 2; 4 days post booster (all timepoints optional)]

Secondary ID(s)

2U19AI089992-11

2U19AI089992-06A1

2000029889

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Allergy and Infectious Diseases (NIAID)

Robert Leet and Clara Guthrie Patterson Trust