Only 56 spots left

~56 spots leftby Apr 2026

COVID-19 Booster Vaccines for Autoimmune Diseases

Recruiting in Palo Alto (17 mi)

+33 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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)

Research Team

Judith A. James, MD, PhD

Principal Investigator

Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation

Meggan C. Mackay, MD, MS

Principal Investigator

Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research

Dinesh Khanna, MBBS, MSc

Principal Investigator

University of Michigan Health, Michigan Medicine

Amit Bar-Or, MD, FRCP

Principal Investigator

Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania

Virginia Pascual, MD

Principal Investigator

Drukier Institute for Children's Health, Weill Cornell Medical College

Stacy Ardoin, MD

Principal Investigator

Nationwide Children's Hospital Rheumatology Department

Natasha Mckerran Ruth, MD

Principal Investigator

Medical University of South Carolina, Pediatric Rheumatology

Tracey Wright, MD

Principal Investigator

UT Southwestern Medical Center, Pediatric Rheumatology

Eligibility Criteria

Adults and children with autoimmune diseases like lupus, arthritis, MS, or pemphigus who had a weak response to previous COVID-19 vaccines can join. They must be on certain immune-suppressing meds and not have active infections or recent severe vaccine reactions.

Inclusion Criteria

I am 18 or older with lupus, scleroderma, RA, MS, or pemphigus.

I have multiple sclerosis or pemphigus.

To be eligible to participate in the study, you must meet all of the criteria below:

See 3 more

Exclusion Criteria

I have common variable immunodeficiency and/or am on immune globulin replacement therapy.

You didn't have a good response to the first COVID-19 vaccine you received.

I received both Janssen and mRNA COVID-19 vaccines before Stage 2 Screening.

See 23 more

Treatment Details

Interventions

Ad26.COV2.S (Vaccine)
BNT162b2 (Vaccine)
Moderna mRNA-1273 (Vaccine)

Trial OverviewThe trial is testing different booster shots of COVID-19 vaccines in people with autoimmune diseases taking immune system medications. It's checking which boosters help the most when the first vaccine doses didn't work well enough.

Participant Groups

43Treatment groups

Experimental Treatment

Group I: Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions

Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Sanofi-GSK COVID-19 vaccine, per protocol instruction

Group II: Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)Experimental Treatment3 Interventions

Adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group III: Cohort F, Arm F2P: Moderna mRNA-1273, Bivalent + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions

Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group IV: Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)Experimental Treatment5 Interventions

Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group V: Cohort F, Arm F1P: BNT162b2, Bivalent + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions

Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.

Group VI: Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)Experimental Treatment2 Interventions

Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will continue to take their prescribed BCDTs without alterations in schedule and dosing. Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.

Group VII: Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)Experimental Treatment2 Interventions

Group VIII: Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)Experimental Treatment3 Interventions

Adult participants who previously received the Janssen COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group IX: Cohort E, Arm E2P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group X: Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)Experimental Treatment5 Interventions

Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group XI: Cohort E, Arm E1P: BNT162b2, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.

Group XII: Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)Experimental Treatment2 Interventions

Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.

Group XIII: Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Group XIV: Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)Experimental Treatment3 Interventions

Adult participants who previously received the Janssen COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group XV: Cohort D, Arm D2P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group XVI: Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)Experimental Treatment5 Interventions

Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction. Beginning with version 6.0 of the protocol, bivalent versions of the mRNA vaccines, Moderna and Pfizer-BioNTech COVID-19 vaccines, replaced original monovalent versions.

Group XVII: Cohort D, Arm D1P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who previously received the Moderna COVID-19 vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.

Group XVIII: Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Arm closed, effective protocol version 4.0. Adult participants who previously received an mRNA vaccine and who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease, will withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.

Group XIX: Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions

Arm closed, effective protocol version 3.0. Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XX: Cohort C, Arm C2P: BNT162b2, Bivalent + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions

Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXI: Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions

Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXII: Cohort C, Arm C1P: Moderna mRNA-1273, Bivalent + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions

Pediatric participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXIII: Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)Experimental Treatment2 Interventions

Adult participants taking B cell depletion medication(s) for management of their underlying autoimmune disease, regardless of whether they are also taking MMF or MTX, will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXIV: Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)Experimental Treatment2 Interventions

Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.

Group XXV: Cohort B, Arm B5P: BNT162b2, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.

Group XXVI: Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)Experimental Treatment2 Interventions

Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster, per protocol instruction.

Group XXVII: Cohort B, Arm B4P: Moderna mRNA-1273, Bivalent + Withhold IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group XXVIII: Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)Experimental Treatment2 Interventions

Adult Participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group XXIX: Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)Experimental Treatment2 Interventions

Arm closed, effective protocol version 3.0. Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXX: Cohort B, Arm B2P: BNT162b2, Bivalent + Continue IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXXI: Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)Experimental Treatment2 Interventions

Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXXII: Cohort B, Arm B1P: Moderna mRNA-1273, Bivalent + Continue IS (MTX)Experimental Treatment2 Interventions

Pediatric participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXXIII: Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)Experimental Treatment2 Interventions

Adult participants who are taking methotrexate (without additional B cell depleting medications or MMF/ MPA) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine booster and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XXXIV: Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after the Janssen COVID-19 vaccine booster (1 dose), per protocol instruction.

Group XXXV: Cohort A, Arm A5P: BNT162b2, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.

Group XXXVI: Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Pfizer-BioNTech COVID-19 vaccine, per protocol instruction.

Group XXXVII: Cohort A, Arm A4P: Moderna mRNA-1273, Bivalent + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group XXXVIII: Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)Experimental Treatment2 Interventions

Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will withhold their immunosuppressive medications (IS) before and after receiving an additional dose of the Moderna COVID-19 vaccine, per protocol instruction.

Group XXXIX: Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)Experimental Treatment2 Interventions

Arm closed, effective protocol version 3.0. Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive the Janssen COVID-19 vaccine booster (1 dose) and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XL: Cohort A, Arm A2P: BNT162b2, Bivalent + Continue IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XLI: Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)Experimental Treatment2 Interventions

Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XLII: Cohort A, Arm A1P: Moderna mRNA-1273, Bivalent + Continue IS (MMF or MPA)Experimental Treatment2 Interventions

Pediatric participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.

Group XLIII: Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)Experimental Treatment2 Interventions

Adult participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) for management of their underlying autoimmune disease will receive an additional dose of the Moderna COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing.