NCT05089565

Brief Summary

People with sarcoidosis, particularly those with significant lung and/or cardiac involvement, who become infected with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) are likely at increased risk of complications or death from COVID-19. While SARS-CoV-2 vaccines are highly efficacious in preventing COVID-19 in the general population, whether vaccination provides similar protection in people with sarcoidosis is unknown. The investigators hypothesize that people with sarcoidosis develop less robust antibody and cell-mediated immune responses to SARS-CoV-2 vaccination than healthy individuals, both as a consequence of the disease itself and due to treatment with immunosuppressive medications. This hypothesis will be examined by determining levels of anti-SARS-CoV-2 spike protein immunoglobulin G (IgG) antibody (Specific Aim 1) and measuring SARS-CoV-2-specific activation of peripheral blood T cells (Specific Aim 2) following SARS-CoV-2 vaccination in individuals with sarcoidosis treated and not treated with immunosuppressive medications, in comparison to age- and sex-matched healthy controls. For Specific Aim 1, a second-generation anti-SARS-CoV-2 spike IgG assay calibrated against an independent virus neutralization assay will be utilized. The results of this investigation will address a critical gap in the understanding of vaccine responses in people with sarcoidosis. In addition, the study will contribute knowledge needed to inform clinicians' recommendations to sarcoidosis patients regarding risk of infection after SARS-CoV-2 vaccination, and will help lay the basis for future trials to evaluate the possible benefit of vaccine boosters in individuals with poor immune responses to initial vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

October 19, 2021

Last Update Submit

January 31, 2023

Conditions

SarcoidosisSARS-CoV2 InfectionVaccine Response Impaired

Keywords

sarcoidosisSARS-CoV-2vaccinationspike antibodycell-mediated immune responseCOVID-19interferon-gamma

Outcome Measures

Primary Outcomes (2)

  • Humeral immune response

    Anti-spike IgG level

    2 weeks to 1 year following primary vaccination, or primary + booster vaccination

  • Cell-mediated immune response

    Level of interferon-gamma release by peripheral blood T cells in response to SARS-CoV-2 peptide stimulation

    2 weeks to 1 year following primary vaccination, or primary + booster vaccination

Study Arms (3)

Sarcoidosis, not on treatment

Sarcoidosis patients, 18 years of age or older, not currently being treated with immunosuppressive medications

Diagnostic Test: Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation

Sarcoidosis, on treatment

Sarcoidosis patients, 18 years of age or older, currently being treated with immunosuppressive medications

Diagnostic Test: Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation

Healthy controls

Healthy individuals, matched for age and sex with those in the two sarcoidosis cohorts

Diagnostic Test: Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulation

Interventions

Assay of (1) the level of anti-spike IgG antibody, and (2) interferon-gamma release in response to SARS-CoV-2 antigen stimulationDIAGNOSTIC_TEST

Measurement of humeral and cell-mediated immune responses to SARS-CoV-2 vaccination

Healthy controlsSarcoidosis, not on treatmentSarcoidosis, on treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As above

You may qualify if:

  • Age 18 years or older
  • Diagnosis of sarcoidosis
  • Receives clinical care at Northwestern Medicine in the Pulmonary Clinic, Cardiology Clinic or other Northwestern Medicine clinical unit
  • Completed primary vaccination, or primary plus booster vaccination, with the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, or Johnson \& Johnson JNJ-78436735 SARS-CoV-2 vaccine at least two weeks prior to enrollment

You may not qualify if:

  • Unable to provide informed consent in English
  • Age 18 years or older
  • Completed primary vaccination, or primary plus booster vaccination, with the Pfizer-BioNTech BNT162b2, Moderna mRNA-1273, or Johnson \& Johnson JNJ-78436735 SARS-CoV-2 vaccine at least two weeks prior to enrollment
  • Diagnosis of sarcoidosis or autoimmune diseases
  • Diagnosis of chronic lung disease
  • Diagnosis of heart disease
  • Diagnosis of cancer
  • Currently taking immunosuppressive medications
  • Unable to provide informed consent in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Simon D, Tascilar K, Fagni F, Kronke G, Kleyer A, Meder C, Atreya R, Leppkes M, Kremer AE, Ramming A, Pachowsky ML, Schuch F, Ronneberger M, Kleinert S, Hueber AJ, Manger K, Manger B, Berking C, Sticherling M, Neurath MF, Schett G. SARS-CoV-2 vaccination responses in untreated, conventionally treated and anticytokine-treated patients with immune-mediated inflammatory diseases. Ann Rheum Dis. 2021 Oct;80(10):1312-1316. doi: 10.1136/annrheumdis-2021-220461. Epub 2021 May 6.

    PMID: 33958324BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, peripheral blood mononuclear cells

MeSH Terms

Conditions

SarcoidosisCOVID-19

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Sporn, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 19, 2021

First Posted

October 22, 2021

Study Start

December 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)