COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

Summary

This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result \>200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine.

The study will focus on 5 autoimmune diseases in adults:

* Systemic Lupus Erythematosus (SLE)
* Rheumatoid Arthritis (RA)
* Multiple Sclerosis (MS)
* Systemic Sclerosis (SSc), and
* Pemphigus.

This study will focus on 4 autoimmune diseases in pediatric participants:

* Systemic Lupus Erythematosus (SLE)
* Juvenile Idiopathic Arthritis (JIA)
* Pediatric-Onset Multiple Sclerosis (POMS)
* Juvenile Dermatomyositis (JDM)

Conditions

• Rheumatoid Arthritis (RA)
• Systemic Lupus Erythematosus (SLE)
• Pemphigus Vulgaris
• Multiple Sclerosis (MS)
• Systemic Sclerosis (SSc)
• Pediatric SLE
• Juvenile Idiopathic Arthritis (JIA)
• Juvenile Dermatomyositis (JDM)
• Pediatric-Onset Multiple Sclerosis (POMS)

Interventions

BIOLOGICAL

Moderna mRNA-1273

Administration: One dose administered intramuscularly.

BIOLOGICAL

BNT162b2

Administration: One dose administered intramuscularly.

BIOLOGICAL

Ad26.COV2.S

Administration: One dose administered intramuscularly.

DRUG

Continue IS (MMF or MPA)

Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.

DRUG

Continue IS (MTX)

Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.

BIOLOGICAL

Continue IS (B cell depletion therapy)

Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.

BIOLOGICAL

Monovalent [B.1.351] CoV2 preS dTM-AS03

One dose administered intramuscularly

DRUG

Withhold IS (MMF or MPA)

Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.

DRUG

Withhold IS (MTX)

Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.

DRUG

Withhold IS (B cell depletion therapy)

Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after the additional vaccine dose per protocol instructions. Participants will continue to take their prescribed BCDTs without alterations in schedule and dosing.

BIOLOGICAL

Moderna mRNA-1273, Bivalent

Administration: One dose administered intramuscularly.

BIOLOGICAL

BNT162b2, Bivalent

Administration: One dose administered intramuscularly.

Sponsors & Collaborators

• Autoimmunity Centers of Excellence

  collaborator OTHER

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Judith A. James, MD, PhD · Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation

• Meggan C. Mackay, MD, MS · Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research

• Dinesh Khanna, MBBS, MSc · University of Michigan Health, Michigan Medicine

• Amit Bar-Or, MD, FRCP · Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania

• Virginia Pascual, MD · Drukier Institute for Children's Health, Weill Cornell Medical College

• Stacy Ardoin, MD · Nationwide Children's Hospital Rheumatology Department

• Natasha Mckerran Ruth, MD · Medical University of South Carolina, Pediatric Rheumatology

• Tracey Wright, MD · UT Southwestern Medical Center, Pediatric Rheumatology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-13

Primary Completion

2023-06-22

Completion

2024-03-28

FDA Drug

Yes

Countries

• United States

Study Locations