Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01)

Who is this study for? Patients with Arthritis, Pemphigus Vulgaris, Multiple Sclerosis
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: No
View:

‣ Individuals 18 years of age or older that meet classification criteria for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), rheumatoid arthritis (RA), multiple sclerosis (MS), or pemphigus

‣ Participants must meet the 2019 ACR/EULAR or 2012 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.

‣ 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 6. Must be currently taking one of the following IS medications with or without additional disease-related medications: MMF (minimum of 1000 mg per day)/MPA (minimum of 720 mg per day), MTX (minimum of 7.5mg per week), or B cell depleting agents within the past 18 months (such as rituximab, ocrelizumab, 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 BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.

• No changes in background IS medications, including MMF/MPA or MTX, in the 4 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.

‣ Adult General Exclusion Criterion 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.

⁃ Adult female participants who are planning a pregnancy during the course of the trial.

‣ Adult Stage 1-Specific Inclusion Criterion 5. 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 either:

‣ i.2 doses of the Pfizer-BioNTech COVID-19 Vaccine ii. 2 doses of the Moderna COVID-19 Vaccine

‣ Adult Stage 1-Specific Exclusion Criterion 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.

‣ Adult Stage 2 (Newly Recruited)-Specific Inclusion Criteria 2. History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.

• Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:

‣ 3 doses of the Pfizer-BioNTech COVID-19 Vaccine

‣ 3 doses of the Moderna COVID-19 Vaccine

‣ 2 doses of the Janssen COVID-19 Vaccine

‣ 4 or more doses of a single mRNA vaccine (Pfizer-BioNTech COVID-19 Vaccine OR Moderna COVID-19 Vaccine)

‣ 3 or more doses of a mixture of mRNA vaccines (Pfizer-BioNTech COVID-19 Vaccine OR Moderna COVID-19 Vaccine)

‣ Adult Stage 2 (Newly Recruited)-Specific Exclusion Criteria:

• Receipt of a mixture of Janssen COVID-19 vaccines and mRNA COVID-19 vaccines (in any order or combination) prior to Stage 2 Screening.

‣ Adult Stage 2 (Rollover)-Specific Inclusion Criteria:

‣ Individuals who were previously enrolled in Adult Stage 1 or Adult Stage 2 will have met some inclusion and exclusion criteria at that time. Only a subset of the criteria for (re-)entering Adult Stage 2 will be assessed in rollover participants at the time of screening for Stage 2.

‣ Individuals who meet all of the following criteria are eligible to (re )enter Adult Stage 2:

• History of severe allergic reaction to the COVID-19 vaccine, or to any component of the COVID-19 vaccine, that is to be administered in Stage 2, including polysorbate for participants receiving the Sanofi-GSK COVID-19 Vaccine, or to PEG.

• Negative or suboptimal serologic response to a previous COVID 19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:

‣ a. 3 doses of the Pfizer-BioNTech COVID-19 Vaccine b. 3 doses of the Moderna COVID-19 Vaccine c. 2 doses of the Janssen COVID-19 Vaccine d. 4 doses of a combination of mRNA vaccines (i.e., Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine)

‣ General Pediatric Inclusion Criteria

‣ Individuals 2-17 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, the International League of Associations for Rheumatology (ILAR) classification for JIA, the 2017 McDonald 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 be assessed based on the disease that is selected for study entry.

‣ Parents/guardians of all pediatric participants and participants ages 14 - 17 must be willing and able to sign informed consent. Participants ages 7-13 must be willing and able to sign assent.

• 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 BCDT cohort, participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months.

• No changes in background IS medications, including MMF/MPA or MTX, in the 8 weeks prior to Screening, excluding the following:

‣ a. HCQ, b. Intraarticular steroids, c. The addition of prednisone at <0.15mg/kg/dose per day or prednisone at any dose when given for ≤3 days, and d. Corticosteroid bursts for non-autoimmune disease-related conditions, such as asthma or COPD, are permitted

‣ General Pediatric Exclusion Criteria 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.

‣ Pediatric Stage 1-Specific Inclusion Criteria:

• Negative or suboptimal serologic response to initial EUA-authorized or FDA-approved COVID-19 vaccine doses, defined as an Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 1 Baseline/Week 0 visit

‣ Initial COVID-19 vaccine regimen is defined as:

‣ i. Pfizer-BioNTech COVID-19 Vaccine (2 through 4 years of age): 3 age-appropriate doses ii. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years of age): 2 age-appropriate doses iii. Moderna COVID-19 Vaccine (2 through 17 years of age): 2 age-appropriate doses.

‣ Pediatric Stage 1-Specific Exclusion Criteria:

‣ Individuals who meet any of these criteria are not eligible for randomization/allocation as participants in the pediatric portion of the study:

• Receipt of a COVID-19 vaccine booster prior to Screening.

‣ Pediatric Stage 2 (Newly Recruited)-Specific Inclusion Criteria 5. Negative or suboptimal serologic response to homologous doses of COVID-19 vaccine in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows: a. Pfizer-BioNTech COVID-19 Vaccine (2 through 5 years of age): 4 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine b. Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years old): 3 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine Note: Participants who are 5 years old and previously received the Pfizer-BioNTech COVID-19 Vaccine may have received either age-appropriate regimen.

‣ c. Moderna COVID-19 Vaccine (12 through 17 years of age): 3 full, age-appropriate doses of the Moderna COVID-19 Vaccine

‣ Pediatric Stage 2 (Newly Recruited)-Specific Exclusion Criteria:

• Receipt of an additional heterologous COVID-19 vaccine dose prior to Stage 2 Screening, i.e., a participant cannot have received a mixture of mRNA vaccines.

‣ Pediatric Stage 2 (Rollover)-Specific Inclusion Criteria:

• Negative or suboptimal serologic response to a previous COVID-19 vaccine administration in one of the qualifying regimens, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) negative result or positive result of ≤200 U/mL, or a low immune response, defined as an Elecsys® Anti-SARS-CoV-2 S (RBD) result of ≤2500 U/mL, within 4 weeks of the Stage 2 Baseline/Week 0 visit. The regimens of COVID-19 vaccination that qualify are as follows:

‣ Pfizer-BioNTech COVID-19 Vaccine (2 through 5 years of age): 4 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine

‣ Pfizer-BioNTech COVID-19 Vaccine (5 through 17 years old): 3 full, age-appropriate doses of the Pfizer-BioNTech COVID-19 Vaccine Note: Participants who are 5 years old and previously received the Pfizer-BioNTech COVID-19 Vaccine may have received either age-appropriate regimen.

‣ Moderna COVID-19 Vaccine (12 through 17 years of age): 3 full, age-appropriate doses of the Moderna COVID-19 Vaccine

Locations
United States
California
UCLA Medical Center: Division of Rheumatology
Recruiting
Los Angeles
Connecticut
Yale University School of Medicine: Rheumatology, Allergy & Immunology
Recruiting
New Haven
Georgia
The Emory Clinic: Division of Rheumatology
Recruiting
Atlanta
Massachusetts
Boston Children's Hospital: Department of Pediatrics, Rheumatology Program
Recruiting
Boston
Brigham & Women's Hospital: Department of Medicine, Rheumatology, Immunology
Recruiting
Boston
Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Recruiting
Boston
Michigan
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Recruiting
Ann Arbor
Missouri
Washington University School of Medicine in St. Louis: Division of Rheumatology
Recruiting
Saint Louis
North Carolina
Duke University Medical Center: Division of Rheumatology and Immunology
Recruiting
Durham
New York
Feinstein Institute for Medical Research
Recruiting
Manhasset
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Recruiting
Manhasset
Columbia University Irving Medical Center: Department of Neurology, Multiple Sclerosis Center
Recruiting
New York
New York University Langone Medical Center: Department of Medicine, Division of Rheumatology
Recruiting
New York
University of Rochester Medical Center
Recruiting
Rochester
Stony Brook University Hospital
Recruiting
Stony Brook
Ohio
Cleveland Clinic
Recruiting
Cleveland
Nationwide Children's Hopspital
Recruiting
Columbus
Oklahoma
Oklahoma Children's Hospital-Pediatrics Specialties Clinic
Recruiting
Oklahoma City
Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program
Recruiting
Oklahoma City
Pennsylvania
Temple Health: Rheumatology
Recruiting
Philadelphia
University of Pennsylvania Perelman Center for Advanced Medicine
Recruiting
Philadelphia
South Carolina
Medical University of South Carolina, Nexus Research Center
Recruiting
Charleston
Medical University of South Carolina, Shawn Jenkins Children's Hospital
Recruiting
Charleston
Texas
University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics
Recruiting
Houston
Washington
Benaroya Research Institute at Virginia Mason: Internal Medicine
Recruiting
Seattle
Time Frame
Start Date: August 13, 2021
Estimated Completion Date: November 2024
Participants
Target number of participants: 2340
Treatments
Experimental: Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A2: BNT162b2 + Continue IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A3: Ad26.COV2.S + Continue IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A5: BNT162b2 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A6: Ad26.COV2.S + Withhold IS (MMF or MPA)
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.
Experimental: Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)
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.
Experimental: Cohort B, Arm B2: BNT162b2 + Continue IS (MTX)
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.
Experimental: Cohort B, Arm B3: Ad26.COV2.S + Continue IS (MTX)
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.
Experimental: Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)
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.
Experimental: Cohort B, Arm B5: BNT162b2 + Withhold IS (MTX)
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.
Experimental: Cohort B, Arm B6: Ad26.COV2.S + Withhold IS (MTX)
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.
Experimental: Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)
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.
Experimental: Cohort C, Arm C2: BNT162b2 + Continue IS (B cell depletion therapy)
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.
Experimental: Cohort C, Arm C3: Ad26.COV2.S + Continue IS (B cell depletion therapy)
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.
Experimental: Cohort D, Arm D1: Ad26.COV2.S + Withhold IS (MMF or MPA)
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.
Experimental: Cohort D, Arm D2: Alternative mRNA Vaccine + Withhold IS (MMF or MPA)
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.
Experimental: Cohort D, Arm D3: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort E, Arm E1: Ad26.COV2.S + Withhold IS (MTX)
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.
Experimental: Cohort E, Arm E2: Alternative mRNA Vaccine + Withhold IS (MTX)
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.
Experimental: Cohort E, Arm E3: Moderna mRNA-1273 + Withhold IS (MTX)
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.
Experimental: Cohort F, Arm F1: Ad26.COV2.S + Withhold IS (B cell depletion therapy)
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.
Experimental: Cohort F, Arm F2: Alternative mRNA Vaccine + Withhold IS (B cell depletion therapy)
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.
Experimental: Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)
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.
Experimental: Cohort D, Arm D4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MMF or MPA)
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 Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Experimental: Cohort E, Arm E4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (MTX)
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 Sanofi-GSK COVID-19 vaccine, per protocol instruction.
Experimental: Cohort F, Arm F4: Monovalent [B.1.351] CoV2 preS dTM-AS03 + Withhold IS (B cell depletion therapy)
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
Experimental: Cohort A, Arm A1P: Moderna mRNA-1273 + Continue IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A2P: BNT162b2 + Continue IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A4P: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort A, Arm A5P: BNT162b2 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort B, Arm B1P: Moderna mRNA-1273 + Continue IS (MTX)
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.
Experimental: Cohort B, Arm B2P: BNT162b2 + Continue IS (MTX)
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.
Experimental: Cohort B, Arm B4P: Moderna mRNA-1273 + Withhold IS (MTX)
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.
Experimental: Cohort B, Arm B5P: BNT162b2 + Withhold IS (MTX)
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.
Experimental: Cohort C, Arm C1P: Moderna mRNA-1273 + Continue IS (B cell depletion therapy)
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.
Experimental: Cohort C, Arm C2P: BNT162b2 + Continue IS (B cell depletion therapy)
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.
Experimental: Cohort D, Arm D1P: BNT162b2 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF or MPA)
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.
Experimental: Cohort E, Arm E1P: BNT162b2 + Withhold IS (MTX)
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.
Experimental: Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX)
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.
Experimental: Cohort F, Arm F1P: BNT162b2 + Withhold IS (B cell depletion therapy)
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.
Experimental: Cohort F, Arm F2P: Moderna mRNA-1273 + Withhold IS (B cell depletion therapy)
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.
Authors
Amit Bar-Or, Zachary S. Wallace, Jeffrey A. Cohen, Sharon Nachman, Amit Saxena, Arezou Khosroshahi, Jeffrey A. Sparks, Joyce Hui-Yuen, Judith A. James, Maureen McMahon, Maureen D Mayes, Meggan C. Mackay, Alfred Kim, Sandra M. Lord, Stacy Ardoin, Sarah Wesley, Dinesh Khanna, Roberto Caricchio, Fotios Koumpouras, Mindy Lo, Natasha L. Ruth, Diane L Kamen, Ana Iris Quintero Del Rio, Christopher Palma, Ankoor Shah
Sponsors
Collaborators: Autoimmunity Centers of Excellence, Rho Federal Systems Division, Inc.
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

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