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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05286242
Other study ID # 2000029889
Secondary ID 2U19AI089992-112
Status Active, not recruiting
Phase
First received
Last updated
Start date February 10, 2021
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This will be a prospective, observational cohort study consisting of individuals with autoimmune diseases who are undergoing treatment with anti-CD20 medications at the time they receive a vaccine against COVID-19. Control groups will include healthy individuals, individuals with autoimmune diseases on other immunomodulators, and individuals with autoimmune diseases not on immunotherapy. Participants will undergo serial blood draws and saliva collections at prespecified time points surrounding vaccination. A subset of agreeable participants will undergo skin biopsy within days of the first vaccination, with the option to repeat skin biopsy after the second vaccination. Additional blood, saliva and skin biopsy specimens may be obtained after booster vaccinations or after known COVID19 infections . Specimens collected will be used for studies aimed at (1) understanding the pathobiology of neurologic/inflammatory/immune diseases and the immunologic response to COVID-19 vaccination, (2) identifying how and why treatments used for neurologic/immune diseases may impact the effectiveness of vaccination, and (3) identifying dermatologic manifestations of the immunologic response to the COVID-19 mRNA vaccine. The investigators are investigating both the production of antibodies against the virus over time and deeply interrogating the T-cell response to vaccination using methods that measure T-cell reactivity to the COVID-19 virus, including single cell RNA sequencing.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date June 30, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
COVID19 vaccine
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.

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Institute of Allergy and Infectious Diseases (NIAID), Robert Leet and Clara Guthrie Patterson Trust

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Skin biopsy analysis Histologic and immunologic characterization of skin biopsy specimens, comparing vaccinated to unvaccinated arm, at one or more timepoints post-vaccination 7 days post vaccine 1; 7 days post vaccine 2; 4 days post booster (all timepoints optional)
Secondary Measurement of COVID19 antibodies in saliva Descriptive assessment of whether COVID antibodies can be detected in saliva at any time point 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 Immune analysis Deep immunologic assessment (flow cytometry, single cell RNA sequencing) of blood specimens; descriptive analysis at each timepoint with comparisons over time will be performed. 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 Changes in patient reported outcomes: COVID history Subjective reports of vaccination-associated symptoms and COVID risk factors (COVID-19 survey) 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 Change in patient reported outcomes: patient reported disability steps Subjects will complete Patient Derived Disability Step score 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 Change in patient reported outcomes: overall symptoms SymptoMS screening questionnaire 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
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