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COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000216
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : August 18, 2022
Sponsor:
Collaborators:
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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 immunosuppressive medications. All study participants will have negative serologic or sub-optimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S (RBD) result ≤ 200 U/mL) to initial COVID-19 vaccine regimen with Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen 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)

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Systemic Lupus Erythematosus (SLE) Pemphigus Vulgaris Multiple Sclerosis Systemic Sclerosis (SSc) Pediatric SLE Juvenile Idiopathic Arthritis Juvenile Dermatomyositis Pediatric-Onset Multiple Sclerosis (POMS) Biological: Moderna mRNA-1273 Biological: BNT162b2 Biological: Ad26.COV2.S Drug: IS (MMF or MPA) Drug: IS (MTX) Biological: IS (B cell depletion therapy) Phase 2

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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Adults

Stage 1: Participants in Cohorts A and B will be randomized into two immunosuppressive (IS) medication treatment plans as follows:

  • Participants continue to take their cohort-defining IS medications without alterations in schedule and dosing
  • Participants withhold their cohort-defining IS medications before and after additional homologous vaccine dose, per protocol instruction Cohort C: No randomization-Participants continue to take their IS medications without alterations in schedule and dosing.

Stage 2: Participants in Cohorts D and E will withhold their cohort-defining IS medications before and after additional alternative vaccine dose, per protocol instruction Cohort F: No randomization-Participants withhold their IS medications before and after additional alternative vaccine dose, per protocol instruction

Pediatric Population: Participants in Cohorts A and B will be randomized into the same two IS medication treatment plans, as defined in Adults Stage 1.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: Cohort A, Arm A1: Moderna mRNA-1273 +IS (MMF or MPA)
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort A, Arm A2: BNT162b2 +IS (MMF or MPA)
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.
Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort A, Arm A3: Ad26.COV2.S + IS (MMF or MPA)

Arm closed, effective protocol version 3.0.

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.

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort A, Arm A4: Moderna mRNA-1273
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Experimental: Cohort A, Arm A5: BNT162b2
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.
Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Experimental: Cohort A, Arm A6: Ad26.COV2.S

Arm closed, effective protocol version 3.0.

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.

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Experimental: Cohort B, Arm B1: Moderna mRNA-1273 + IS (MTX)
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort B, Arm B2: BNT162b2 + IS (MTX)
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.
Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort B, Arm B3: Ad26.COV2.S + IS (MTX)

Arm closed, effective protocol version 3.0.

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.

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort B, Arm B4: Moderna mRNA-1273
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Experimental: Cohort B, Arm B5: BNT162b2
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.
Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Experimental: Cohort B, Arm B6: Ad26.COV2.S

Arm closed, effective protocol version 3.0.

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.

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Experimental: Cohort C, Arm C1: Moderna mRNA-1273 +IS (B cell depletion therapy)
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb

Experimental: Cohort C, Arm C2: BNT162b2+IS (B cell depletion therapy)
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.
Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb

Experimental: Cohort C, Arm C3: Ad26.COV2.S +IS (B cell depletion therapy)

Arm closed, effective protocol version 3.0.

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.

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb

Experimental: Cohort D, Arm D1: mRNA Vaccine + IS (MMF or MPA) + Ad26.COV2.S
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort D, Arm D2: mRNA Vaccine + IS (MMF or MPA) + Alternative mRNA Vaccine
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort D, Arm D3: Ad26.COV2.S + IS (MMF or MPA) + Moderna mRNA-1273
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • immunosuppressive medication
  • mycophenolate mofetil
  • MMF
  • CellCept®
  • mycophenolic acid
  • MPA

Experimental: Cohort E, Arm E1: mRNA Vaccine + IS (MTX) + Ad26.COV2.S
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort E, Arm E2: mRNA Vaccine + IS (MTX) + Alternative mRNA Vaccine
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort E, Arm E3: Ad26.COV2.S + IS (MTX) + Moderna mRNA-1273
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.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Drug: IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
Other Names:
  • methotrexate
  • MTX

Experimental: Cohort F, Arm F1: mRNA Vaccine + IS (B cell depletion therapy) + Ad26.COV2.S
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 withhold their immunosuppressive medications (IS) before and after receiving a dose of the Janssen COVID-19 vaccine, per protocol instruction.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb

Experimental: Cohort F, Arm F2: mRNA Vaccine + IS (B cell depletion therapy) + Alternative mRNA Vaccine
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 MT,, will withhold their immunosuppressive medications (IS) before and after receiving a dose of an alternative COVID-19 vaccine, per protocol instruction.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: BNT162b2
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Pfizer/BioNTech)
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb

Experimental: Cohort F, Arm F3: Ad26.COV2.S + IS (B cell depletion therapy) + Moderna mRNA-1273
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 withhold their immunosuppressive medications (IS) before and after receiving a dose of the Moderna COVID-19 vaccine, per protocol instruction.
Biological: Moderna mRNA-1273
Administration: One dose administered intramuscularly.
Other Names:
  • mRNA-1273 vaccine (Moderna)
  • Moderna COVID-19 Vaccine
  • SARS-CoV-2 RNA vaccine
  • COVID-19 vaccine

Biological: Ad26.COV2.S
Administration: One dose administered intramuscularly.
Other Names:
  • Janssen COVID-19 Vaccine
  • JNJ-78436735

Biological: IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
Other Names:
  • mAbs targeting CD19 or CD20
  • anti-BAFF mAb




Primary Outcome Measures :
  1. Proportion of adult and pediatric participants who have a protective antibody response at Week 4 [ Time Frame: Week 4 Status Post Receipt of COVID-19 Vaccination ]
    Efficacy measure.


Secondary Outcome Measures :
  1. Percentage of Subset Participants Who Seroconverted [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 ]
    Efficacy measure, evaluated in subset of participants who are anti-COVID-19 antibody negative at Baseline.

  2. Fold increase in anti-COVID-19 antibody levels at Week 4, following participant receipt of a booster dose of COVID-19 vaccine [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine booster), Week 4 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    Efficacy measure, evaluated in subset of participants who are anti-COVID-19 antibody positive at Week 0 (Baseline).

  3. Change in anti-COVID-19 antibody response [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 ]
    Efficacy measure.

  4. Change in anti-SARS-CoV-2 neutralizing antibody levels [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine booster) and Weeks 4, 12, 24, 36, and 48 ]
    Efficacy measure, employing neutralization and pseudo-neutralization assays.

  5. Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Clinical Global Impression of Change (CGI-C) [ Time Frame: Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Dose ]

    A measure of disease activity and efficacy.

    CGI-C: Clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.


  6. Change in disease activity after receipt of additional doses of COVID-19 vaccine as measured by the Physician's Global Assessment [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of disease activity and efficacy.

  7. Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of SLE disease activity and efficacy.

  8. Change in disease activity in adult participant subset with Systemic Lupus Erythematosus (SLE) as measured by Thanou modified SELENA-SLEDAI Flare Index for Systemic Lupus Erythematosus (SLE) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 ]
    A measure of SLE disease activity and efficacy.

  9. Change in disease activity in adult participant subset with Rheumatoid Arthritis (RA) as measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of RA disease activity and efficacy.

  10. Change in disease activity in adult participant subset with Systemic Sclerosis (SSc) as measured by Disease Flare Activity [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]

    A measure of SSc disease activity and efficacy.

    SSc disease flare assessments (including participant self- reported flare assessment). A flare is indicative of increased SSc-related disease activity.


  11. Change in disease activity in adult participant subset with Pemphigus as measured by Disease Area Index (PDAI) for Pemphigus [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]

    A measure of pemphigus disease activity and efficacy.

    The PDAI is specific cutaneous and mucosal disease activity assessment performed by the physician and is based on evaluation of lesions in well-defined anatomical locations.


  12. Change in disease activity in adult participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of MS disease activity and efficacy.

  13. Change in disease activity in pediatric participant subset with juvenile idiopathic arthritis (JIA) as measured by JADAS10 [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of JIA disease activity and efficacy.

  14. Change in disease activity in pediatric participant subset with JIA as measured by Psoriasis Area and Severity Index (PASI) for psoriatic arthritis [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of JIA disease activity and efficacy.

  15. Change in disease activity in pediatric participant subset with pediatric-onset multiple sclerosis (POMS) as measured by SLEDAI-2K [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of MS disease activity and efficacy.

  16. Change in disease activity in pediatric participant subset with POMS as measured by childhood-onset SLE Criteria for Global Flare [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of POMS disease activity and efficacy.

  17. Change in disease activity in pediatric participant subset with juvenile dermatomyositis (JDM) as measured by Childhood Mysositis Assessment Scale [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of JDM disease activity and efficacy.

  18. Change in disease activity in pediatric participant subset with JDM as measured by JDM Disease Activity Score (DAS) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of JDM disease activity and efficacy.

  19. Change in disease activity in pediatric participant subset with Multiple Sclerosis (MS) as measured by Physician assessed relapse for MS (POMS) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of MS disease activity and efficacy.

  20. Change in disease activity in adult participants as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of disease activity and efficacy. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) self-report assesses functioning and well-being in physical, mental and social domains of health. The PROMIS-29 consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.

  21. Change in disease activity in pediatric participants as measured by the Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of disease activity and efficacy. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) self-report assesses functioning and well-being in physical, mental and social domains of health. The PROMIS-29 consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.

  22. Change in disease activity as measured by the Patient Global Assessment [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of disease activity and efficacy. The patient global assessment of disease activity is measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=<week status post receipt of booster vaccine> score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.

  23. Change in disease activity as measured by the Patient Global Impression of Change (PGI-C) [ Time Frame: Baseline (prior to receipt of COVID-19 vaccine doses) and Weeks 4, 12, 24, 36, and 48 Status Post Receipt of COVID-19 Vaccine Booster Dose ]
    A measure of disease activity and efficacy. Participant's Global Impression of Change Reported on PGI-C Scale (1-7 Point Scale Ranging From 1 "Very Much Improved" to 7 "Very Much Worse").

  24. Proportion of participants who experience any solicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine [ Time Frame: Through Day 7 post study vaccination ]
    Safety measure status post receipt of study vaccination.

  25. Proportion of participants who experience any unsolicited Grade 1 or higher adverse events related to additional doses of the COVID-19 vaccine [ Time Frame: Through Day 28 post study vaccination ]
    Safety measure status post receipt of study vaccination.

  26. Proportion of participants who experience any serious adverse events (SAEs) [ Time Frame: Up to Week 48 post study vaccination ]
    Safety measure status post receipt of study vaccination.

  27. Proportion of participants who experience any medically attended adverse events (MAAEs) [ Time Frame: Up to Week 48 post study vaccination ]
    Safety measure status post receipt of study vaccination.

  28. Proportion of participants who experience any New Onset Chronic Medical Conditions (NOCMCs) [ Time Frame: Up to Week 48 post study vaccination ]
    Safety measure status post receipt of study vaccination.

  29. Proportion of participants who experience any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection [ Time Frame: Up to Week 48 post study vaccination ]
    Efficacy measure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Adults:

Individuals who meet all the following criteria are eligible for enrollment as study participants-

  1. Individuals that meet classification criteria for:

    • systemic lupus erythematosus (SLE)
    • systemic sclerosis (SSc)
    • rheumatoid arthritis (RA)
    • multiple sclerosis (MS), or
    • pemphigus
  2. Participants must meet:

    • the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) or the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria (SLICC) classification criteria for SLE
    • the 2010 ACR/EULAR classification criteria for RA
    • the 2013 EULAR/ACR classification criteria for SSc
    • the 2017 McDonald criteria for MS, and
    • the international consensus criteria for pemphigus

    Note: If a participant has been diagnosed with more than one autoimmune disease, the participant will be assessed based on the disease that is selected for study entry

  3. Willing and able to sign informed consent
  4. Documented full COVID-19 vaccination (e.g., Centers for Disease Control and Prevention [CDC] vaccination card or documentation in medical records) that was completed ≥ 4 weeks prior and no more than 52 weeks prior to the Screening visit
  5. Negative serologic or suboptimal response to initial COVID-19 vaccine regimen- defined as an Elecsys® Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (anti-SARS-CoV-2-spike (S) protein receptor binding domain (RBD)) result ≤ 200 U/mL at Screening visit

    -Initial COVID-19 vaccine regimen is defined as either:

    • 2 doses of the Pfizer-BioNTech COVID-19 vaccine
    • 2 doses of the Moderna COVID-19 vaccine, or
  6. Must be currently taking one of the following IS medications with or without additional disease related medications:

    • mycophenolate mofetil (minimum of 1,000 mg per day)/mycophenolic acid (minimum of 720 mg per day)
    • methotrexate (minimum of 7.5mg per week), or
    • B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, or ofatumumab)

      • If taking mycophenolate mofetil (MMF)/mycophenolic acid (MPA) or methotrexate (MTX), the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen
      • Participants on B cell depleting therapy may enter the study if they are also taking MMF/MPA or MTX. In this case, the MMF/MPA or MTX would not be withheld for the vaccine booster dose(s)
      • Participants taking both MMF/MPA and MTX will be excluded from the study
  7. No changes in background IS medications in the 8 weeks prior to Screening, excluding the following:

    • hydroxychloroquine (HCQ)
    • Intraarticular steroids
    • The addition of prednisone at ≤10 mg per day or prednisone at any dose when given for ≤ 3 days, and
    • Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or chronic obstructive pulmonary disease (COPD), are permitted

Exclusion Criteria Adults:

Individuals who meet any of these criteria are not eligible for enrollment as study participants-

  1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, or any component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG)
  3. Ongoing treatment for a malignancy with chemotherapy or immunotherapy
  4. Active disease (per the Investigator's decision) resulting in inability to hold the immunosuppressive therapy in the Mycophenolate Mofetil (MMF)/Mycophenolic Acid (MPA) or Methotrexate (MTX) arms of the study

    The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered

  5. Active disease during the Screening period resulting in:

    • an increase/addition of immunosuppressive medications, or
    • a suggestion of multiple sclerosis (MS) relapse per the investigator
  6. Recent or current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection defined as:

    • Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening), or
    • A positive result on a molecular COVID-19 test at Screening
  7. Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19 vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine
  8. Participants with:

    • a history of autoimmune disease-related myocarditis within 3 years
    • autoimmune disease-related pericarditis within the past year, or
    • inflammatory myocarditis/pericarditis following initial COVID-19 vaccine regimen
  9. Participants with active bacterial or viral infections who have received antibiotics within the 14 days prior to Screening, including participants with evidence of:

    • Human Immunodeficiency Virus (HIV)
    • Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity
    • Hepatitis C as indicated by anti-hepatitis C antibody positivity

      • Note: If a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening
  10. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy
  11. Participants who received licensed or investigational monoclonal antibodies or plasma products directed against SARS-CoV-2 within 30 days of Screening
  12. Participants who have received any live vaccines within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study
  13. Currently pregnant or breastfeeding
  14. Participants who are planning a pregnancy during the course of the trial
  15. Hemoglobin (Hgb) < 8.0 g/dL (80 g/L)
  16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator:

    • may pose additional risks from participation in the study
    • may interfere with the participant's ability to comply with study requirements, or
    • that may impact the quality or interpretation of the data obtained from the study
  17. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of enrollment
  18. Concurrent treatment with cyclophosphamide, cladribine, alemtuzumab, or mitoxantrone
  19. Participants currently on any type of dialysis, or who have received a solid organ transplant
  20. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
  21. Taking both MMF/MPA and MTX.
  22. Receiving other investigational B cell depleting therapy as part of a clinical trial within one year18 months of Screening, unless drug assignment is known and the participant received an anti-CD20 or CD19 drug.
  23. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening.

Inclusion Criteria Pediatric:

  1. Individuals 5-17 years of age that meet classification criteria for SLE, JIA, POMS, or JDM. Note: Juvenile idiopathic arthritis includes the following conditions: polyarticular JIA (both RF + and-), oligoarticular persistent and oligoarticular extended JIA, psoriatic arthritis, and enthesitis related JIA.

    • Participants must meet the 2017 EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups [8], the International League of Associations for Rheumatology (ILAR) classification for JIA [4], the 2017 McDonald [6] criteria for MS, or the Bohan and Peter criteria or the 2017 EULAR/ACR classification criteria for JDM.
    • If a participant has been diagnosed with more than one autoimmune disease, the participant will beassessed based on the disease that is selected for study entry.
  2. Parents/guardians of pediatric participants must be willing and able to sign informed consent. Participants, ages 7-17, must be willing and able to sign assent.
  3. Documented full COVID-19 vaccination (CDC card or documentation in medical records) that was completed at least 4 weeks prior and no more than 52 weeks prior to the Screening visit.
  4. Negative or suboptimal serologic response to initial COVID-19 vaccine regimen, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL at Screening visit.

    • Initial COVID-19 vaccine regimen is defined as:
    • - 2 doses (as appropriate to age) of the Pfizer-BioNTech COVID-19 Vaccine

    The following vaccines have yet to receive EUA in pediatric populations. If EUA occurs for younger ages, the participants receiving age-appropriate regimens of the following COVID-19 vaccines may be enrolled into the study:

    • - Moderna COVID-19 Vaccine
    • - Janssen COVID-19 Vaccine
  5. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 250 mg per day)/MPA (minimum of 360 mg per day), MTX (minimum of 5 mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, or ofatumumab).

    • If taking MMF/MPA or MTX, the participant must have initiated therapy at least 8 weeks prior to randomization and be taking the same medications (regardless of dose) as at the time of the initial COVID-19 vaccine regimen. Note: Participants who withheld their IS medications around their initial vaccinations are eligible to participate.
    • If enrolling in the B cell depleting therapy cohort, participant must have received an anti-CD20 or an anti-CD19 B cell depleting therapy in the past 18 months.
  6. No changes in background IS medications, including MMF/MPA or MTX, in the 8 weeks prior to Screening, excluding the following:

    • HCQ,
    • Intraarticular steroids,
    • The addition of prednisone at ≤10mg per day or prednisone at any dose when given for ≤3 days, and
    • Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted.

Exclusion Criteria Pediatric:

  1. Inability or unwillingness of a participant to give assent or of a parent/guardian to give written informed consent, or of either to comply with study protocol.
  2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, or any component of any of the COVID-19 vaccines, or to PEG.
  3. New diagnosis of malignancy that will require chemotherapy or immunotherapy, or ongoing treatment for a malignancy with chemotherapy or immunotherapy.
  4. Active disease (per the Investigator's decision) resulting in inability to hold the IS therapy in the MMF/MPA or MTX arms of the study.

    - The potential impact of temporarily holding medication for participants with a recent mild disease flare within 4 weeks should be carefully considered.

  5. Active disease during the Screening period resulting in:

    • an increase/addition of any IS medications, or
    • a suggestion of MS relapse per the investigator
  6. Recent or current SARS-CoV-2 infection defined as:

    • Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening).
    • Positive result on a molecular COVID-19 test at Screening.
  7. Receipt of a COVID-19 vaccine booster prior to Screening.
  8. Inflammatory myocarditis/pericarditis following initial COVID-19 vaccine regimen.
  9. Participants with active, ongoing chronic infections, including participants with evidence of:

    • HIV.
    • Hepatitis B as indicated by surface antigen.
    • Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening. Note: Participants are permitted to be on chronic prophylactic antimicrobial therapy.
  10. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy.
  11. Participants who received licensed or investigational monoclonal antibodies or plasma products directed against SARS-CoV-2 within 30 days of Screening.
  12. Participants who have received any live vaccines within 2 months of the anticipated study vaccine dose or who will have need of a live vaccine at any time during the study.
  13. Currently pregnant or breastfeeding (postmenarchal females must have a negative urine pregnancy test at Screening)
  14. Hemoglobin (Hgb) <8.0 g/dL (80 g/L)
  15. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  16. Other investigational chemical agent within 30 days or other investigational biologic agent within 8 weeks or 5 half-lives (whichever is longer) of Screening.
  17. Concurrent treatment with cyclophosphamide.
  18. Participants currently on any type of dialysis, or who have received a solid organ transplant.
  19. Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be allowed to participant in this study.
  20. Taking both MMF/MPA and MTX.
  21. Other investigational B cell depleting therapy as part of a clinical trial within 18 months of Screening, unless drug assignment is known and the participant received an anti-CD20 or CD19 drug.
  22. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000216


Locations
Show Show 25 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
Investigators
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Study Chair: Judith A. James, MD, PhD Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation
Study Chair: Meggan C. Mackay, MD, MS Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research
Study Chair: Dinesh Khanna, MBBS, MSc University of Michigan Health, Michigan Medicine
Study Chair: Amit Bar-Or, MD, FRCP Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania
Study Chair: Virginia Pascual, MD Drukier Institute for Children's Health, Weill Cornell Medical College
Study Chair: Stacy Ardoin, MD Nationwide Children's Hospital Rheumatology Department
Study Chair: Natasha Mckerran Ruth, MD Medical University of South Carolina, Pediatric Rheumatology
Study Chair: Tracey Wright, MD UT Southwestern Medical Center, Pediatric Rheumatology
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT05000216    
Other Study ID Numbers: DAIT ACV01
NIAID CRMS ID#: 38873 ( Other Identifier: DAIT NIAID )
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Time Frame: On average, within 24 months after database lock for the trial.
Access Criteria: Open access.
URL: https://www.immport.org/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
SARS-CoV-2 Infection
COVID-19
autoimmune disease
non-responders to COVID-19 vaccination
suboptimal response to COVID-19 vaccination
COVID-19 booster vaccine
booster effects with autoimmune treatments
Additional relevant MeSH terms:
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COVID-19
Arthritis
Arthritis, Juvenile
Dermatomyositis
Multiple Sclerosis
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Pemphigus
Autoimmune Diseases
Sclerosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases
Rheumatic Diseases