Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS), Systemic Sclerosis (SSc), Pediatric SLE, Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Pediatric-Onset Multiple Sclerosis (POMS)
Conditions
Keywords
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
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 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)
Detailed description
Adult Population: Stage 1 of this trial will enroll up to a maximum of 900 adult study participants (up to 60 participants per arm). Participants will be assigned to one of 3 cohorts based on their IS regimens: * Cohort A: Receipt of MMF or MPA * Cohort B: Receipt of MTX * Cohort C: Receipt of any BCDT within the past 18 months. Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive an additional dose of the same COVID-19 vaccine as their original vaccine series. The trial initially enrolled participants who were vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, the Moderna COVID-19 Vaccine, and the Janssen COVID-19 Vaccine. Update: Arms to receive an additional homologous vaccine dose after an initial Janssen COVID 19 Vaccine were closed to enrollment after the CDC updated its recommendations to express a clinical preference for individuals to receive an mRNA COVID-19 vaccine over the Janssen COVID-19 vaccine. All Adult Stage 1 treatment arms were closed to enrollment on 15 August 2022. Participants in Cohorts A and B will be randomized into 2 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 the additional homologous vaccine dose per protocol instructions. A participant will be enrolled in the study for a maximum of approximately 13 months. Stage 2 of this trial will include up to a maximum of 960 adult study participants (up to 80per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (at least 3 doses of mRNA vaccine(s) or 2 doses of the Janssen COVID-19 Vaccine). Participants will be eligible to receive a dose of an alternative COVID-19 vaccine. Participants may have received their previous COVID-19 vaccine prior to enrollment in the study (newly recruited participant), or they may have received their previous COVID-19 vaccine as a study participant and then (re-) enter into Stage 2 (rollover participant). Participants can also roll over into Stage 2 via two pathways: * Stage 1 participant rolls over to Stage 2 * Stage 2 participant rolls over to a different Stage 2 treatment arm Participants will be allocated to 1 of 3 cohorts based on their IS regimens: * Cohort D: Receipt of MMF or MPA * Cohort E: Receipt of MTX * Cohort F: Receipt of any BCDT within the past 18 months. Treatment Arms: Participants in Cohorts D, E, and F will receive a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Originally, participants who previously received 3 total doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer- BioNTech COVID-19 Vaccine) received their choice of either the Janssen vector-based COVID-19 vaccine or the other mRNA COVID-19 vaccine, and participants who previously received 2 doses of the Janssen vector based COVID-19 vaccine received the Moderna COVID-19 Vaccine. Update: Beginning with v4.0 of the protocol, this trial will not utilize the Janssen vector-based COVID-19 vaccine. Participants who previously received 3 total doses of a single mRNA vaccine will receive their choice of an alternative mRNA COVID-19 vaccine or the Sanofi-GSK protein based COVID-19 vaccine. Participants who previously received 4 or more doses of a single mRNA vaccine or 3 or more doses of a mixture mRNA vaccines (Moderna COVID-19 Vaccine AND Pfizer-BioNTech COVID-19 Vaccine, in any order or combination) will receive the Sanofi-GSK protein-based COVID-19 vaccine. Participants in Cohorts D and E will withhold their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions. Participants in Cohort F who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications before and after the alternative vaccine dose per protocol instructions. Visits to assess endpoints will occur at Baseline (Week 0), Week 4 ± 1 week, Week 12 ± 2 weeks, Week 24 ± 2 weeks, Week 36 ± 2 weeks, and Week 48 ± 2 weeks. A participant who is newly recruited to the study for entry into Stage 2 may be on study for up to a maximum of 13 months. A participant who enters Stage 2 after a serologic negative, suboptimal, or low immune response to their Stage 1 vaccine dose may be on study for up to a maximum of 26 months. Rollover participants will discontinue follow-up as part of Stage 1 upon rollover into Stage 2. A participant who rolls over to a different Stage 2 treatment arm 2 after a serologic negative, suboptimal, or low immune response to another Stage 2 vaccine dose may be on study for up to a maximum of 38 months. Pediatric Population: Stage 1 in the pediatric portion of this trial will enroll up to a maximum of 800 participants (2-17 years of age) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after receiving an initial COVID-19 vaccine regimen (up to 80participants per arm). Vaccines will be included in this protocol as they receive EUA or approval by FDA for a given age group. Pediatric participants will have 1 of 4 autoimmune diseases: pediatric SLE, juvenile idiopathic arthritis (JIA), juvenile dermatomyositis (JDM), or pediatriconset multiple sclerosis (POMS). Participants will be assigned to 1 of 3 cohorts based on their IS regimens: * Cohort A: Receipt of MMF or MPA * Cohort B: Receipt of MTX * Cohort C: Receipt of any BCDT within the past 18 months. Treatment Arms: Participants in Cohorts A, B, and C will be assigned to receive an additional dose of the same vaccine as their original vaccine series. Based on FDA EUA status, pediatric participants were initially eligible to receive the Pfizer-BioNTech COVID-19 Vaccine only. Participants in Cohorts A and B will be randomized into 2 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 the additional homologous vaccine dose per protocol instructions. A participant will be enrolled in the study for a maximum of approximately 13 months. Stage 2 of the pediatric portion of this trial will include up to a maximum of 480 pediatric study participants (up to 80 per arm) with a Roche Elecsys® Anti-SARS-CoV-2 S result ≤2500 U/mL after previous COVID-19 vaccine administration (an age-appropriate EUA-authorized or FDA-approved initial COVID-19 vaccine regimen plus 1 additional dose of the same vaccine). All participants (2-17 years of age) who previously received doses of the Pfizer-BioNTech COVID-19 Vaccine are eligible to receive an age-appropriate dose of the Moderna COVID-19 Vaccine. Participants 12 through 17 years of age who previously received doses of the Moderna COVID-19 vaccine are eligible to receive an age-appropriate dose of the Pfizer-BioNTech COVID-19 Vaccine. Participants will be eligible to receive a dose of an alternative COVID-19 vaccine. Participants may have received their previous COVID-19 vaccine as a study participant and then enter into Stage 2 (rollover participant), or they may have received their previous COVID-19 vaccine prior to enrollment in the study (newly recruited participant). Participants will be allocated to 1 of 3 cohorts based on their IS regimens: * Cohort D: Receipt of MMF or MPA (± other rheumatic disease medications, including biologics) o Participants who are taking MMF or MPA (without additional B cell depleting medications or MTX) will be placed in this cohort. * Cohort E: Receipt of MTX (± other rheumatic disease medications, including biologics) o Participants who are taking MTX (without additional B cell depleting medications or MMF/ MPA) will be placed in this cohort. * Cohort F: Receipt of B cell depletion therapy within the past 18 months (± other rheumatic disease medications) o Participants taking B cell depletion medications, regardless of whether they are also taking MMF or MTX, will be placed in this cohort. Treatment Arms: Participants in Cohorts D, E, and F will receive a dose of an alternative COVID-19 vaccine compared to their previous COVID-19 vaccine doses. Participants who previously received age-appropriate doses of a single mRNA vaccine (Moderna COVID-19 Vaccine OR Pfizer-BioNTech COVID-19 Vaccine, as noted above) will receive the other mRNA COVID-19 vaccine. Beginning with v7.0 of the protocol all vaccines used are bivalent versions replacing original monovalent versions. Participants in Cohorts D and E will withhold their cohort-defining IS medications before and after the alternative vaccine dose per protocol instructions (see Section 7.1.1 Protocol-mandated Medications). Participants in Cohort F who are taking MMF, MPA, or MTX in addition to B cell depletion therapies (BCDTs) will withhold these medications before and after the alternative vaccine dose per protocol instruction. A participant who enters Stage 2 after a serologic negative, suboptimal, or low immune response to their Stage 1 vaccine dose may be on study for up to a maximum of 26 months. Rollover participants will discontinue follow-up as part of Stage 1 upon rollover into Stage 2. A participant who is newly recruited to the study for entry into Stage 2 may be on study for up to a maximum of 13 months. Adaptive Design An adaptive design will be employed such that cohorts and arms defined by additional vaccine doses and IS treatment plans may be added or modified based on emerging data from existing and new FDA Emergency Use Authorization (EUA) or approvals of COVID-19 vaccines: * New cohorts may be defined based on changes in the medication groups if it becomes obvious that certain medications are highly associated with suboptimal or low immune serologic response to initial COVID-19 vaccine regimen. * Cohorts may limit or expand the autoimmune diseases that are eligible to be included in the clinical trial and may include expansion cohorts of underrepresented diseases. * New cohorts may include participants whose antibody response falls to suboptimal or low immune levels over time. * Based upon timing of the FDA EUA authorization for children of each of the COVID-19 vaccines used in this trial, the age range of the inclusion criteria may be expanded. * Allocation or randomization to treatment with new COVID-19 vaccines may be incorporated into the design when the products become available. * Identification of additional strategies to enhance vaccine responsiveness in autoimmune diseases, including a temporary switch of immunomodulatory medications.
Interventions
BIOLOGICALModerna mRNA-1273
Administration: One dose administered intramuscularly.
BIOLOGICALBNT162b2
Administration: One dose administered intramuscularly.
BIOLOGICALAd26.COV2.S
Administration: One dose administered intramuscularly.
DRUGContinue IS (MMF or MPA)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
DRUGContinue IS (MTX)
Participants continue to take their immunosuppressive (IS) medications for management of their autoimmune disease without alterations in schedule and dosing.
BIOLOGICALContinue IS (B cell depletion therapy)
Participants will continue to take their prescribed immunosuppressive (IS) medications without alterations in schedule and dosing.
BIOLOGICALMonovalent [B.1.351] CoV2 preS dTM-AS03
One dose administered intramuscularly
DRUGWithhold IS (MMF or MPA)
Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.
DRUGWithhold IS (MTX)
Participants withhold their cohort-defining immunosuppressive (IS) medications for management of their autoimmune disease before and after the additional vaccine dose per protocol instructions.
DRUGWithhold IS (B cell depletion therapy)
Participants who are taking MMF, MPA, or MTX in addition to BCDTs will withhold these medications (MMF, MPA, or MTX ) before and after the additional vaccine dose per protocol instructions. Participants will continue to take their prescribed BCDTs without alterations in schedule and dosing.
BIOLOGICALModerna mRNA-1273, Bivalent
Administration: One dose administered intramuscularly.
BIOLOGICALBNT162b2, Bivalent
Administration: One dose administered intramuscularly.
Sponsors
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Adults and Pediatrics 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
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Adult Inclusion Criteria: 1\. Willing and able to sign informed consent 2. 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 Stage 1 Screening visit, or if participating in Stage 2, no more than 48 weeks prior to the Stage 2 Screening visit. General
Exclusion criteria
2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, to any component of any of the COVID-19 vaccines, or to polyethylene glycol (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. a. 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: 1. An increase/addition of any IS medications, or 2. A suggestion of MS relapse per the investigator. 6. Recent or current SARS-CoV-2 infection defined as: <!-- --> 1. Documented SARS-CoV-2 infection in the past 30 days (from the day the participant is diagnosed by positive test to Screening). 2. Positive result on a molecular COVID-19 test at Screening. 8. Inflammatory myocarditis/pericarditis within 6 weeks of any COVID-19 vaccine doses. 9\. Participants with active, ongoing chronic infections. Note: Participants are permitted to be on chronic prophylactic antimicrobial therapy. Adults with evidence of HIV, Hepatitis B indicated by surface antigen, and Hepatitis C indicated by anti-hepatitis C antibody positivity will be excluded. If an adult is negative for Hepatitis C viral load at Screening, he/she will be eligible to participate. 10\. Participants with common variable immunodeficiency disease, as well as any participants currently receiving immune globulin replacement therapy. Note: Pediatric participants on IVIG therapeutically may enter the study provided they have sufficiently quiet disease that they can withhold their IVIG from 8 weeks prior to the Screening visit through 4 weeks after vaccination. 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 (For pediatric participants postmenarchal females must have a negative urine pregnancy test at Screening). 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 Screening. 18\. Concurrent treatment with cyclophosphamide. Adult participants taking cladribine, alemtuzumab, or mitoxantrone will also be excluded. 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. 21\. Taking both MMF/MPA and MTX. 22. Receiving other investigational BCDT 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. 23\. Participants with active systemic infections who have received systemic antimicrobials within the 14 days prior to Screening. Adult General Criteria Inclusion Criteria: 1. 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 2. 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. <!-- --> 1. 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). <!-- --> 1. 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. 2. If enrolling in the BCDT cohort, the participant must have received an anti-CD20 or an anti-CD19 BCDT in the past 18 months. 7\. No changes in background IS medications, including MMF/MPA or MTX, in the 4 weeks prior to Screening, excluding the following: <!-- --> 1. HCQ, 2. Intraarticular steroids, 3. The addition of prednisone at ≤10mg per day or prednisone at any dose when given for ≤3 days, and 4. 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. 14\. 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. <!-- --> 1. 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. 5\. 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: 1. 3 doses of the Pfizer-BioNTech COVID-19 Vaccine 2. 3 doses of the Moderna COVID-19 Vaccine 3. 2 doses of the Janssen COVID-19 Vaccine 4. 4 or more doses of a single mRNA vaccine (Pfizer-BioNTech COVID-19 Vaccine OR Moderna COVID-19 Vaccine) 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial. |
| Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial. |
| Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4 | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0). |
| Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. |
| Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. |
| Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding. |
| Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding. |
| Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50. |
| Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50. |
| Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs. |
| Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs. |
| Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease. |
| Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease. |
| Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse. |
| Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse. |
| Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Juvenile Arthritis Disease Activity Score 10-C-reactive Protein (JADAS10-CRP) is a score on a scale (0 to 40) indicating activity of juvenile idiopathic arthritis. Total active joints are scored 0 to 10, with an active joint count \>10 scored as 10 points. The Physician's Global Assessment and Patient's Global Assessment are measured on a 0-10 scale (0 cm, no disease activity to 10 cm, worst disease activity). CRP is normalized to a 0 to 10 scale according to the following formula: (CRP (mg/L) - 10)/10. CRP values \<10 mg/L are scored as 0, and CRP \>110 mg/L are scored as 10. The final score is given by the simple sum of its component. Higher scores indicate worse disease activity. |
| Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain. |
| Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain. |
| Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | Up to Week 48 post study vaccination | All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | Up to Week 48 post study vaccination | All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | Up to Week 48 post study vaccination | An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | Up to Week 48 post study vaccination | An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | Up to Week 48 post study vaccination | Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine. |
| Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | Up to Week 48 post study vaccination | Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine. |
| Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | Up to Week 48 post study vaccination | A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention. |
| Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | Up to Week 48 post study vaccination | A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention. |
| Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | Up to Week 48 post study vaccination | Efficacy measure. |
| Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | Up to Week 48 post study vaccination | COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0. |
| Percentage of Stage 2 Pediatric Participants Who Seroconverted | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit. |
| Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0). |
| Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. |
| Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding. |
| Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present. |
| Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose | The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity). |
| Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose | The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Percentage of Stage 1 Adult Participants Who Seroconverted | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit. |
| Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs) | Up to Week 48 post study vaccination | An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above. |
| Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | Up to Week 48 post study vaccination | Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine. |
| Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | Up to Week 48 post study vaccination | A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention. |
| Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | Up to Week 48 post study vaccination | COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0. |
| Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | Up to Week 48 post study vaccination | All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0. |
| Percentage of Stage 2 Adult Participants Who Seroconverted | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit. |
| Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Week 4 Status Post Receipt of COVID-19 Vaccination | Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0). |
Countries
United States
Participant flow
Recruitment details
19 adult sites and 12 pediatric sites were activated in the United States. 374 adult participants and 9 pediatric participants were screened from August 2021 until April 2023 in Stage 1 and 2 of the trial. Adult arms A3, B3, B6, D1, D3, E1, and E3; Pediatric Stage 1; Pediatric Stage 2 arms D1P, E1P, F1P, and F2P did not randomized/allocate or vaccinate participants. One participant was allocated to Adult arm F1 but was not vaccinated.
Pre-assignment details
In Stage 2, participants could be newly recruited, consent to rollover from Stage 1 of the trial (43 participants), or could consent to receive a second vaccine (Sanofi-GSK) after receipt of a mRNA vaccine in Stage 2 (19 participants).
Participants by arm
| Arm | Count |
|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 2 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 2 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 9 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 10 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) Stage 1 adult participants who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 2 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 3 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Moderna mRNA-1273 COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 3 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 11 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) Stage 1 adult participants who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine (but not for more than 21 days total), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 11 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Moderna mRNA-1273 COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 41 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 45 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) Stage 1 adult participants taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate, mycophenolate mofetil or mycophenolic acid, will receive an additional dose of the Ad26.COV2.S (Janssen) COVID-19 vaccine and continue to take their immunosuppressive medications (IS) without alterations in schedule and dosing. | 9 |
| Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 9 |
| Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) Stage 2 adult participants who previously received an mRNA vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose | 5 |
| Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of an alternative COVID-19 vaccine (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 8 |
| Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) Stage 2 adult participants who previously received an mRNA vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Sanofi-GSK (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 6 |
| Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) 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 (Moderna mRNA-1273 or Pfizer-BioNTech (BNT162b2)), per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total | 57 |
| Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) Stage 2 adult participants who previously received the Janssen COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) 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 mRNA-1273 vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total. | 2 |
| Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) 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 (Monovalent \[B.1.351\] CoV2 preS dTM-AS03) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total. | 20 |
| Cohort F, Arm F1: Janssen + Withhold IS (BCDT) Stage 2 adult participants who previously received an mRNA COVID-19 vaccine and who are taking B cell depletion therapy (BCDT) for management of their underlying autoimmune disease, regardless of whether they are also taking methotrexate (MTX), mycophenolate mofetil (MMF) or mycophenolic acid (MPA), will continue to take their prescribed, cohort-defining, immunosuppressive medications (IS) 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 Ad26.COV2.S (Janssen) vaccine, per protocol instruction. MMF and MPA: hold 3 days before and 10 days after vaccine. MTX: hold for at least 7 days before and at least 7 days after vaccine, but not for more than 21 days total. | 1 |
| Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19 vaccine and who are taking mycophenolate mofetil (MMF) or mycophenolic acid (MPA) (without additional B cell depleting medications or methotrexate) for management of their underlying autoimmune disease, will withhold their cohort-defining immunosuppressive medications (IS) 3 days before and 10 days after receiving a dose of the Moderna mRNA-1273 Bivalent COVID-19 vaccine, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 1 |
| Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) Stage 2 pediatric participants who previously received the Pfizer-BioNTech COVID-19vaccine and who are taking methotrexate (MTX) (without additional B cell depleting medications or mycophenolate mofetil or mycophenolic acid) for management of their underlying autoimmune disease will withhold their cohort-defining immunosuppressive medications (IS) for at least 7 days before and at least 7 days after receiving a dose of the Moderna mRNA-1273 Bivalent vaccine, but not for more than 21 days total, per protocol instruction. Participants taking additional IS medications (such as tumor necrosis factor \[TNF\] inhibitors, JAK inhibitors, abatacept, belimumab, etc.) will be required to continue them during the time of the additional vaccine dose. | 1 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 | Did not receive vaccine at Week 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Received a SARS-CoV-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Rolled over to Stage 2 of the study | 1 | 0 | 3 | 3 | 0 | 1 | 0 | 2 | 0 | 13 | 18 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 1 | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Did not receive vaccine at Week 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 1 | 0 | 0 |
| Stage 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Other reason | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Received a SARS-CoV-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 6 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 9 | 0 | 0 | 0 | 0 | 0 |
| Stage 2 Sanofi | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Stage 2 Sanofi | Received a SARS-CoV-2 vaccine off study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 |
| Stage 2 Sanofi | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Total | Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Cohort D, Arm D2: Alternative mRNA + Withhold IS (MMF or MPA) | Cohort E, Arm E2: Alternative mRNA + Withhold IS (MTX) | Cohort F, Arm F2: Alternative mRNA + Withhold IS (BCDT) | Cohort F, Arm F3: Moderna mRNA-1273 + Withhold IS (BCDT) | Cohort F, Arm F1: Janssen + Withhold IS (BCDT) | Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) | Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX) | Cohort D, Arm D4: Sanofi-GSK + Withhold IS (MMF or MPA) | Cohort F, Arm F4: Sanofi-GSK + Withhold IS (BCDT) | Cohort E, Arm E4: Sanofi-GSK + Withhold IS (MTX) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical Stage 1 <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Age, Categorical Stage 1 >=65 years | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants | 7 Participants | 8 Participants | 4 Participants | 1 Participants | 34 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Age, Categorical Stage 1 Between 18 and 65 years | 2 Participants | 6 Participants | 9 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants | 4 Participants | 33 Participants | 40 Participants | 8 Participants | 113 Participants | 2 Participants | — | — | — | — | — | — | — | — | — | — |
| Age, Categorical Stage 2 <=18 years | — | — | — | — | — | — | — | — | — | — | — | 3 Participants | — | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | — | — | — |
| Age, Categorical Stage 2 >=65 years | — | — | — | — | — | — | — | — | — | — | — | 14 Participants | — | 3 Participants | 2 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Age, Categorical Stage 2 Between 18 and 65 years | — | — | — | — | — | — | — | — | — | — | — | 62 Participants | — | 6 Participants | 6 Participants | 47 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | — | — | — |
| Age, Categorical Stage 2 Sanofi <=18 years | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Stage 2 Sanofi >=65 years | — | — | — | — | — | — | — | — | — | — | — | 8 Participants | — | — | — | — | — | — | — | — | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Stage 2 Sanofi Between 18 and 65 years | — | — | — | — | — | — | — | — | — | — | — | 23 Participants | — | — | — | — | — | — | — | — | 3 Participants | 16 Participants | 4 Participants |
| Age, Continuous Stage 1 | 41.0 years STANDARD_DEVIATION 9.9 | 50.4 years STANDARD_DEVIATION 16.34 | 44.7 years STANDARD_DEVIATION 13.12 | 59.5 years STANDARD_DEVIATION 0.71 | 70.7 years STANDARD_DEVIATION 5.69 | 64.7 years STANDARD_DEVIATION 17.39 | 62.3 years STANDARD_DEVIATION 7.98 | 66.0 years STANDARD_DEVIATION 9.96 | 51.3 years STANDARD_DEVIATION 14.81 | 45.4 years STANDARD_DEVIATION 13.02 | 55.1 years STANDARD_DEVIATION 7.15 | 51.9 years STANDARD_DEVIATION 14.46 | 62.0 years STANDARD_DEVIATION 2.89 | — | — | — | — | — | — | — | — | — | — |
| Age, Continuous Stage 2 | — | — | — | — | — | — | — | — | — | — | — | 51.5 years STANDARD_DEVIATION 14.39 | — | 51.4 years STANDARD_DEVIATION 16.46 | 62.4 years STANDARD_DEVIATION 4.66 | 51.1 years STANDARD_DEVIATION 13.41 | 54.0 years STANDARD_DEVIATION 5.66 | 54.0 years | 17.0 years | 12.0 years | — | — | — |
| Age, Continuous Stage 2 Sanofi | — | — | — | — | — | — | — | — | — | — | — | 54.7 years STANDARD_DEVIATION 12.73 | — | — | — | — | — | — | — | — | 51.6 years STANDARD_DEVIATION 19.86 | 52.9 years STANDARD_DEVIATION 11.09 | 63.0 years STANDARD_DEVIATION 9.19 |
| Ethnicity (NIH/OMB) Stage 1 Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 16 Participants | 1 Participants | — | — | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Stage 1 Not Hispanic or Latino | 2 Participants | 7 Participants | 8 Participants | 1 Participants | 3 Participants | 2 Participants | 11 Participants | 9 Participants | 40 Participants | 40 Participants | 8 Participants | 132 Participants | 1 Participants | — | — | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Stage 1 Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Ethnicity (NIH/OMB) Stage 2 Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | 5 Participants | — | 1 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Stage 2 Not Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | 74 Participants | — | 8 Participants | 8 Participants | 53 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | — | — | — |
| Ethnicity (NIH/OMB) Stage 2 Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Ethnicity (NIH/OMB) Stage 2 Sanofi Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Stage 2 Sanofi Not Hispanic or Latino | — | — | — | — | — | — | — | — | — | — | — | 31 Participants | — | — | — | — | — | — | — | — | 5 Participants | 20 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Stage 2 Sanofi Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Stage 1 American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 Black or African American | 2 Participants | 3 Participants | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 8 Participants | 2 Participants | 30 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 1 White | 0 Participants | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants | 6 Participants | 38 Participants | 35 Participants | 7 Participants | 109 Participants | 2 Participants | — | — | — | — | — | — | — | — | — | — |
| Race (NIH/OMB) Stage 2 American Indian or Alaska Native | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 Asian | — | — | — | — | — | — | — | — | — | — | — | 2 Participants | — | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 Black or African American | — | — | — | — | — | — | — | — | — | — | — | 9 Participants | — | 2 Participants | 0 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 More than one race | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | 3 Participants | — | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 White | — | — | — | — | — | — | — | — | — | — | — | 65 Participants | — | 6 Participants | 8 Participants | 48 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | — | — | — |
| Race (NIH/OMB) Stage 2 Sanofi American Indian or Alaska Native | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi Asian | — | — | — | — | — | — | — | — | — | — | — | 2 Participants | — | — | — | — | — | — | — | — | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi Black or African American | — | — | — | — | — | — | — | — | — | — | — | 3 Participants | — | — | — | — | — | — | — | — | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi More than one race | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi Native Hawaiian or Other Pacific Islander | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi Unknown or Not Reported | — | — | — | — | — | — | — | — | — | — | — | 0 Participants | — | — | — | — | — | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Stage 2 Sanofi White | — | — | — | — | — | — | — | — | — | — | — | 26 Participants | — | — | — | — | — | — | — | — | 3 Participants | 17 Participants | 6 Participants |
| Region of Enrollment United States Stage 1 | 2 Participants | 9 Participants | 10 Participants | 2 Participants | 3 Participants | 3 Participants | 11 Participants | 11 Participants | 41 Participants | 45 Participants | 9 Participants | 148 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Stage 2 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 79 Participants | 0 Participants | 9 Participants | 8 Participants | 57 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States Stage 2 Sanofi | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 31 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Stage 1 Female | 2 Participants | 8 Participants | 9 Participants | 2 Participants | 2 Participants | 3 Participants | 11 Participants | 10 Participants | 27 Participants | 35 Participants | 5 Participants | 116 Participants | 2 Participants | — | — | — | — | — | — | — | — | — | — |
| Sex: Female, Male Stage 1 Male | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 14 Participants | 10 Participants | 4 Participants | 32 Participants | 0 Participants | — | — | — | — | — | — | — | — | — | — |
| Sex: Female, Male Stage 2 Female | — | — | — | — | — | — | — | — | — | — | — | 62 Participants | — | 9 Participants | 6 Participants | 43 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | — | — | — |
| Sex: Female, Male Stage 2 Male | — | — | — | — | — | — | — | — | — | — | — | 17 Participants | — | 0 Participants | 2 Participants | 14 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | — | — | — |
| Sex: Female, Male Stage 2 Sanofi Female | — | — | — | — | — | — | — | — | — | — | — | 28 Participants | — | — | — | — | — | — | — | — | 5 Participants | 19 Participants | 4 Participants |
| Sex: Female, Male Stage 2 Sanofi Male | — | — | — | — | — | — | — | — | — | — | — | 3 Participants | — | — | — | — | — | — | — | — | 0 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 8 | 0 / 9 | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 10 | 0 / 10 | 0 / 40 | 0 / 45 | 0 / 8 | 0 / 9 | 0 / 5 | 0 / 8 | 0 / 6 | 0 / 53 | 0 / 2 | 0 / 20 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 2 | 0 / 1 | 3 / 8 | 4 / 9 | 0 / 2 | 2 / 3 | 0 / 3 | 3 / 10 | 5 / 10 | 15 / 40 | 12 / 45 | 6 / 8 | 5 / 9 | 2 / 5 | 3 / 8 | 4 / 6 | 20 / 53 | 0 / 2 | 9 / 20 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 8 | 0 / 9 | 1 / 2 | 0 / 3 | 0 / 3 | 0 / 10 | 1 / 10 | 5 / 40 | 4 / 45 | 0 / 8 | 1 / 9 | 1 / 5 | 0 / 8 | 0 / 6 | 6 / 53 | 0 / 2 | 1 / 20 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
Primary
Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
Primary
Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). A threshold for achieving a protective antibody response was not established for the NIAID VRC MSD assay. The intent was to use a pre-established threshold to define a protective antibody response. However, correlates from previous studies could not be extrapolated to the CoV-2 variants circulating over the entire course of this trial.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Wu-1 Full-Length Spike | NA Percentage of participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4 | Week 4, Receptor Binding Domain (RBD) | NA Percentage of participants |
Secondary
Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 5.8 cm | Standard Deviation 1.1 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 7.2 cm | Standard Deviation 2.1 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 7.9 cm | Standard Deviation 0.5 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 7.5 cm | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 6.5 cm | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3 cm | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.5 cm | Standard Deviation 2.9 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 2.7 cm | Standard Deviation 2.3 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.1 cm | Standard Deviation 2.9 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.7 cm | Standard Deviation 3.2 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.8 cm | Standard Deviation 2.9 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3.1 cm | Standard Deviation 2.3 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 5.8 cm | Standard Deviation 1.8 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 4.9 cm | Standard Deviation 4.4 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 6.2 cm | Standard Deviation 1.1 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 4.6 cm | Standard Deviation 1.1 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 4.8 cm | Standard Deviation 1.9 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 6.5 cm | Standard Deviation 0.9 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 5.6 cm | Standard Deviation 1.8 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 5.4 cm | Standard Deviation 1.6 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 6.8 cm | Standard Deviation 1.5 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3.6 cm | Standard Deviation 2.9 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 4.3 cm | Standard Deviation 3.1 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.7 cm | Standard Deviation 2.4 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 4.9 cm | Standard Deviation 3.6 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 5.1 cm | Standard Deviation 3.6 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 4.9 cm | Standard Deviation 3 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.5 cm | Standard Deviation 2.5 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.8 cm | Standard Deviation 2.4 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3.3 cm | Standard Deviation 2.6 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.2 cm | Standard Deviation 2.9 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 2.3 cm | Standard Deviation 2.2 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 2.6 cm | Standard Deviation 2.4 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 2.3 cm | Standard Deviation 2.3 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.9 cm | Standard Deviation 3.2 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3 cm | Standard Deviation 2.6 |
Secondary
Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 37.3 T-Score | Standard Deviation 0.8 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 37.9 T-Score | — |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 39.8 T-Score | Standard Deviation 0.9 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 56.9 T-Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 41.8 T-Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 43.4 T-Score | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 47.6 T-Score | Standard Deviation 10.1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 48.9 T-Score | Standard Deviation 8.7 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 47.6 T-Score | Standard Deviation 10.1 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 42.1 T-Score | Standard Deviation 7.7 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 40.2 T-Score | Standard Deviation 3.9 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 42.7 T-Score | Standard Deviation 10 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 35.6 T-Score | Standard Deviation 3.3 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 41.9 T-Score | Standard Deviation 2.1 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 35 T-Score | Standard Deviation 2.4 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 45.3 T-Score | Standard Deviation 0 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 50.1 T-Score | Standard Deviation 6.1 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 46.5 T-Score | Standard Deviation 2.7 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 42.7 T-Score | Standard Deviation 12.3 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 39.6 T-Score | Standard Deviation 5 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 39.3 T-Score | Standard Deviation 7.5 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 47.2 T-Score | Standard Deviation 10.5 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 46.1 T-Score | Standard Deviation 11.5 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 48.9 T-Score | Standard Deviation 9 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 41.7 T-Score | Standard Deviation 10.5 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 41.8 T-Score | Standard Deviation 12 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 41.1 T-Score | Standard Deviation 11.9 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 43.5 T-Score | Standard Deviation 9.4 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 43.5 T-Score | Standard Deviation 9.5 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 43.5 T-Score | Standard Deviation 9.1 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 44.2 T-Score | Standard Deviation 9.9 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 44.7 T-Score | Standard Deviation 9.5 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 44.7 T-Score | Standard Deviation 10.5 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 44.1 T-Score | Standard Deviation 11.9 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 43.5 T-Score | Standard Deviation 11.8 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 43.6 T-Score | Standard Deviation 11.7 |
Secondary
Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.1 cm | Standard Deviation 1.3 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 2.8 cm | Standard Deviation 1.6 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 2.1 cm | Standard Deviation 2.7 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 0.4 cm | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 0 cm | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 0.2 cm | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.6 cm | Standard Deviation 1.1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.2 cm | Standard Deviation 0.9 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 1.6 cm | Standard Deviation 1.2 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 1.7 cm | Standard Deviation 1.9 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.2 cm | Standard Deviation 1.3 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 2.5 cm | Standard Deviation 2.6 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 3.4 cm | Standard Deviation 4.4 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.9 cm | Standard Deviation 1.5 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 4.5 cm | Standard Deviation 2.8 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.2 cm | Standard Deviation 0.6 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 0.7 cm | Standard Deviation 0.8 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1 cm | Standard Deviation 0.7 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 0.5 cm | Standard Deviation 0.8 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.2 cm | Standard Deviation 1.6 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.8 cm | Standard Deviation 0.8 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 1.2 cm | Standard Deviation 1.2 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 0.7 cm | Standard Deviation 0.9 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.5 cm | Standard Deviation 1.2 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 1.3 cm | Standard Deviation 1.6 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.2 cm | Standard Deviation 1.8 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.3 cm | Standard Deviation 1.1 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.6 cm | Standard Deviation 1.9 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.1 cm | Standard Deviation 1.5 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 1.3 cm | Standard Deviation 1.7 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.6 cm | Standard Deviation 2.6 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 0.8 cm | Standard Deviation 1.5 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 0.5 cm | Standard Deviation 1 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 12 | 1.1 cm | Standard Deviation 1.8 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 0 | 1.3 cm | Standard Deviation 1.8 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Adult Stage 1 Disease Activity as Measured by the Physician's Global Assessment | Week 4 | 0.7 cm | Standard Deviation 1.1 |
Secondary
Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 1.3 cm | Standard Deviation 1.2 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 1.7 cm | Standard Deviation 1.7 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 1.7 cm | Standard Deviation 1.6 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 3.4 cm | Standard Deviation 2.4 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 2.6 cm | Standard Deviation 3.1 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 1.8 cm | Standard Deviation 2.1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 0.5 cm | Standard Deviation 0.4 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 0.4 cm | Standard Deviation 0.4 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 0.6 cm | Standard Deviation 0.5 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 0.9 cm | Standard Deviation 0.6 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 1 cm | Standard Deviation 0.8 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 1 cm | Standard Deviation 0.8 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 1.54 cm | Standard Deviation 1.8 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 1.4 cm | Standard Deviation 2 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 1.6 cm | Standard Deviation 1.8 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 0.8 cm | Standard Deviation 0.1 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 0.2 cm | Standard Deviation 0.1 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 1.1 cm | Standard Deviation 0.9 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 1 cm | Standard Deviation 1.4 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 1.3 cm | Standard Deviation 1.6 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 1.4 cm | Standard Deviation 1.1 |
Secondary
Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 2.9 cm | Standard Deviation 2.7 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3 cm | Standard Deviation 2.1 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.2 cm | Standard Deviation 2.6 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 2.9 cm | Standard Deviation 3.1 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 2.7 cm | Standard Deviation 3.4 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 1.8 cm | Standard Deviation 2.2 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.1 cm | Standard Deviation 2.3 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 3.2 cm | Standard Deviation 2.1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3 cm | Standard Deviation 2.5 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3 cm | Standard Deviation 2 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 2.8 cm | Standard Deviation 2.6 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.9 cm | Standard Deviation 2.7 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 3 cm | Standard Deviation 2.5 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 2.7 cm | Standard Deviation 2.5 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 3.1 cm | Standard Deviation 2.5 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 2.6 cm | Standard Deviation 3.4 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 2.5 cm | Standard Deviation 3.5 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 1 cm | Standard Deviation 1.4 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 1.9 cm | Standard Deviation 2.2 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 2.7 cm | Standard Deviation 2.9 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 2.6 cm | Standard Deviation 2.6 |
Secondary
Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29)
The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Short Form (Version 2.0) will be used to assess trends over time in this state of health measure. The PROMIS-29 consists of 7 domains related to physical, mental and social health. Raw scores are calculated for each domain and translated into a T-score per the PROMIS-29 scoring guide. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Physical Function domain score is presented. A higher score represents better functioning for the Physical Function domain.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 45.5 T-Score | Standard Deviation 9.3 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 46.4 T-Score | Standard Deviation 8.5 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 44.9 T-Score | Standard Deviation 7.9 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 42.5 T-Score | Standard Deviation 10.5 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 46.3 T-Score | Standard Deviation 7.6 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 46.8 T-Score | Standard Deviation 9.3 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 47.6 T-Score | Standard Deviation 9 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 48.3 T-Score | Standard Deviation 10.4 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 48.4 T-Score | Standard Deviation 10.4 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 47.2 T-Score | Standard Deviation 9.4 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 48.3 T-Score | Standard Deviation 8.4 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 44.2 T-Score | Standard Deviation 8.5 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 44.9 T-Score | Standard Deviation 9.6 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 45.9 T-Score | Standard Deviation 9.9 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 43.9 T-Score | Standard Deviation 10 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 56.9 T-Score | Standard Deviation 0 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 51.1 T-Score | Standard Deviation 8.2 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 56.9 T-Score | Standard Deviation 0 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 12 | 48.3 T-Score | Standard Deviation 9.4 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 4 | 48.6 T-Score | Standard Deviation 9.6 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Adult Stage 2 Disease Activity as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS-29) | Week 0 | 47.1 T-Score | Standard Deviation 9.5 |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Time frame: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Multiple Sclerosis (MS) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Pemphigus are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 0 | 1 PDAI Total Activity Score | — |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 4 | 5 PDAI Total Activity Score | — |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 12 | 0 PDAI Total Activity Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 0 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 4 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 12 | 1 PDAI Total Activity Score | Standard Deviation 1.41 |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Rheumatoid Arthritis (RA) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 3 DAS28-CRP Score | Standard Deviation 0.7 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 2.7 DAS28-CRP Score | Standard Deviation 1.1 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 3.5 DAS28-CRP Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2.6 DAS28-CRP Score | Standard Deviation 0.9 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 2.5 DAS28-CRP Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 3.5 DAS28-CRP Score | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 1.6 DAS28-CRP Score | Standard Deviation 0.6 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 2.1 DAS28-CRP Score | Standard Deviation 0.8 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 2.1 DAS28-CRP Score | Standard Deviation 1.1 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2.8 DAS28-CRP Score | Standard Deviation 1.1 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 2.7 DAS28-CRP Score | Standard Deviation 1.3 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 2.8 DAS28-CRP Score | Standard Deviation 1 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 3.3 DAS28-CRP Score | Standard Deviation 1.3 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 3.1 DAS28-CRP Score | Standard Deviation 1.4 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 3.4 DAS28-CRP Score | Standard Deviation 2.3 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 3.3 DAS28-CRP Score | Standard Deviation 1.5 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 3.2 DAS28-CRP Score | Standard Deviation 1.7 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 3.3 DAS28-CRP Score | Standard Deviation 1.1 |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 0 hSLEDAI Score | — |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 0 hSLEDAI Score | — |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 4 hSLEDAI Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 2 hSLEDAI Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 2 hSLEDAI Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 0 hSLEDAI Score | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 3.33 hSLEDAI Score | Standard Deviation 3.27 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 2 hSLEDAI Score | Standard Deviation 2.19 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 3.4 hSLEDAI Score | Standard Deviation 2.97 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 5.57 hSLEDAI Score | Standard Deviation 6.11 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 7.83 hSLEDAI Score | Standard Deviation 6.21 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 5.57 hSLEDAI Score | Standard Deviation 4.31 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 4 hSLEDAI Score | — |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 6 hSLEDAI Score | — |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 0 hSLEDAI Score | — |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 2.67 hSLEDAI Score | Standard Deviation 3.06 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 2 hSLEDAI Score | Standard Deviation 3.46 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 0 hSLEDAI Score | Standard Deviation 0 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 0.67 hSLEDAI Score | Standard Deviation 1.15 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 1.33 hSLEDAI Score | Standard Deviation 2.31 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 0.67 hSLEDAI Score | Standard Deviation 1.15 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 3 hSLEDAI Score | Standard Deviation 4.24 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 2 hSLEDAI Score | Standard Deviation 2.83 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 4 hSLEDAI Score | — |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 4 hSLEDAI Score | Standard Deviation 2.83 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 4 hSLEDAI Score | — |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 4 hSLEDAI Score | Standard Deviation 2.83 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 0 hSLEDAI Score | — |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 0 hSLEDAI Score | — |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 2 hSLEDAI Score | — |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 2 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
Secondary
Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Sclerosis (SSc) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 1 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS
Relapse required: either criteria (a) with investigator determination of relapse or criteria (a) and (b): (a) New, recurrent or worsening neurological symptoms attributable to MS, that meet all of the following: i. Appeared or evolved subacutely (over \<3 months). ii. Persisting \>24 hours. iii. Can't be attributed to confounding factors. iv. Occur ≥30 days after onset of a prior confirmed relapse. (b) New, recurrent or worsening neurological symptoms accompanied by corresponding objective worsening on neurologic examination with an increase of any one of the following compared to the immediate prior assessment: i. ≥0.5 step(s) on the Expanded Disability Status Scale (EDSS), ii. ≥2 points on one Functional Systems Score (FSS), iii. ≥1 point on two or more FSS. Episodic spasms, sexual dysfunction, fatigue, mood change, or bladder/bowel urgency or incontinence will not suffice to establish relapse. Sexual dysfunction and fatigue will not contribute to the EDSS/FSS for assessing relapse.
Time frame: Screening and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Multiple Sclerosis (MS) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Screening | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Multiple Sclerosis (MS) as Measured by Physician Assessed Relapse for MS | MS Relapse at Week 4 | 0 Participants |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus
The Pemphigus Disease Area Index (PDAI) was developed by the International Pemphigus Committee and measures both activity of and damage due to pemphigus on the skin, scalp, and mucous membranes. Total scores can range from 0 to a possible 263 maximum score, with 250 points representing disease activity (120 points for skin activity, 10 points for scalp activity, and 120 points for mucosal activity) and 13 points representing disease damage. Higher scores reflect worse disease.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Pemphigus are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 0 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 4 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 12 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 0 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 4 | 0 PDAI Total Activity Score | Standard Deviation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Pemphigus as Measured by Disease Area Index (PDAI) for Pemphigus | Week 12 | 0 PDAI Total Activity Score | Standard Deviation 0 |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
The Disease Activity Score 28 C-reactive Protein (DAS28-CRP) is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\>5.1=high disease activity; \<=3.2=low disease activity; \<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein in mg/L (CRP) and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm). Reference: van Gestel AM et al. Arthritis Rheum.1998; 41(10): 1845-50.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Rheumatoid Arthritis (RA) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 1.9 DAS28-CRP Score | Standard Deviation 0.6 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 1.9 DAS28-CRP Score | Standard Deviation 0.4 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2.1 DAS28-CRP Score | Standard Deviation 0.5 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 1.8 DAS28-CRP Score | Standard Deviation 0.7 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 2 DAS28-CRP Score | Standard Deviation 0.8 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2 DAS28-CRP Score | Standard Deviation 0.7 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2.6 DAS28-CRP Score | Standard Deviation 1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 2.8 DAS28-CRP Score | Standard Deviation 1.2 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 3 DAS28-CRP Score | Standard Deviation 1.2 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 0 | 3 DAS28-CRP Score | Standard Deviation 0.8 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 12 | 2.3 DAS28-CRP Score | Standard Deviation 0.4 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Rheumatoid Arthritis (RA) as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) | Week 4 | 2.6 DAS28-CRP Score | Standard Deviation 0.9 |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)
The Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 0.7 hSLEDAI Score | Standard Deviation 1.2 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 4 hSLEDAI Score | Standard Deviation 4 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 0.7 hSLEDAI Score | Standard Deviation 1.2 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 4 hSLEDAI Score | Standard Deviation 2.8 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 2 hSLEDAI Score | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 2 hSLEDAI Score | Standard Deviation 0 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 0 | 4 hSLEDAI Score | Standard Deviation 4.4 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 12 | 3 hSLEDAI Score | Standard Deviation 1.4 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) | Week 4 | 4.3 hSLEDAI Score | Standard Deviation 4 |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index
The Thanou Modified Safety of Estrogens in Lupus Erythematosus: National Assessment- Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), other disease activity criteria, and hospitalization due to SLE. The hSLEDAI is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. hSLEDAI total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 0 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Lupus Erythematosus (SLE) as Measured by the Thanou Modified SELENA-SLEDAI Flare Index | Severe SELENA-SLEDAI Flare at Week 4 | 0 Participants |
Secondary
Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity
Severe disease flare included onset of new or significant worsening of internal organ involvement requiring hospitalization or change in treatment. Internal organ involvement included scleroderma renal crisis, interstitial lung disease, left or right sided heart failure, pulmonary arterial hypertension on right-sided heart catheterization or other worsening of internal organs.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants with Systemic Sclerosis (SSc) are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 0 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 12 | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Adult Participants With Systemic Sclerosis (SSc) as Measured by Disease Flare Activity | Severe Flare at Week 4 | 0 Participants |
Secondary
Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10)
The Juvenile Arthritis Disease Activity Score 10-C-reactive Protein (JADAS10-CRP) is a score on a scale (0 to 40) indicating activity of juvenile idiopathic arthritis. Total active joints are scored 0 to 10, with an active joint count \>10 scored as 10 points. The Physician's Global Assessment and Patient's Global Assessment are measured on a 0-10 scale (0 cm, no disease activity to 10 cm, worst disease activity). CRP is normalized to a 0 to 10 scale according to the following formula: (CRP (mg/L) - 10)/10. CRP values \<10 mg/L are scored as 0, and CRP \>110 mg/L are scored as 10. The final score is given by the simple sum of its component. Higher scores indicate worse disease activity.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Juvenile Idiopathic Arthritis (JIA) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10) | Week 0 | 0.8 JADAS10 Score |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10) | Week 4 | 0.6 JADAS10 Score |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Juvenile Idiopathic Arthritis (JIA) as Measured by the Juvenile Arthritis Disease Activity Score 10 (JADAS10) | Week 12 | 0.4 JADAS10 Score |
Secondary
Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K is a validated, physician-based assessment tool used to measure the extent of lupus disease activity within the past 28 days. SLEDAI-2K total score is a weighted sum of the presence of 24 lupus disease symptoms and ranges from 0 to 105, with higher scores indicating more lupus disease activity present.
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants with Systemic Lupus Erythematosus (SLE) are included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K | Week 0 | 2 SLEDAI-2K Score |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K | Week 4 | 2 SLEDAI-2K Score |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Disease Activity in Stage 2 Pediatric Participants With Systemic Lupus Erythematosus (SLE) as Measured by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K | Week 12 | 0 SLEDAI-2K Score |
Secondary
Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment
The Physician's Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 0 cm |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 0 cm |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 0 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 0 | 0.8 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 4 | 0.6 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Physician's Global Assessment | Week 12 | 0.4 cm |
Secondary
Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment
The Patient Global Assessment of the participant's current disease activity is assessed on a 10 cm linear horizontal visual analog scale, where the left hand extreme of the line is considered Very Good (0 cm, no disease activity) and the right hand extreme is considered Very Bad (10 cm, severe disease activity).
Time frame: Baseline and Weeks 4, 12 Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 5 cm |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 5 cm |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 5 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 0 | 0 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 4 | 0 cm |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Pediatric Stage 2 Disease Activity as Measured by the Patient Global Assessment | Week 12 | 0 cm |
Secondary
Change in Stage 1 Adult Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 466.11 IU/mL | Geometric Coefficient of Variation 104511.25 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 356.28 IU/mL | Geometric Coefficient of Variation 6108.73 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 6.45 IU/mL | Geometric Coefficient of Variation 39.72 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 434.06 IU/mL | Geometric Coefficient of Variation 157747.37 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 2.52 IU/mL | Geometric Coefficient of Variation 221.96 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 321.14 IU/mL | Geometric Coefficient of Variation 10668.22 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 2763.2 IU/mL | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 3464.82 IU/mL | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 3734.51 IU/mL | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 207.45 IU/mL | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 3121.73 IU/mL | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 224.49 IU/mL | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 14.52 IU/mL | Geometric Coefficient of Variation 196.41 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 331.49 IU/mL | Geometric Coefficient of Variation 333.85 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 518.82 IU/mL | Geometric Coefficient of Variation 452.03 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 272.17 IU/mL | Geometric Coefficient of Variation 920.54 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 12.34 IU/mL | Geometric Coefficient of Variation 142.28 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 458.18 IU/mL | Geometric Coefficient of Variation 1185.39 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 8.67 IU/mL | Geometric Coefficient of Variation 1803.07 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 12.36 IU/mL | Geometric Coefficient of Variation 424.64 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 632.72 IU/mL | Geometric Coefficient of Variation 2925.17 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 626.32 IU/mL | Geometric Coefficient of Variation 650.04 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 617.58 IU/mL | Geometric Coefficient of Variation 630.84 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 491.61 IU/mL | Geometric Coefficient of Variation 7488.68 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 296.41 IU/mL | Geometric Coefficient of Variation 70.11 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 276.55 IU/mL | Geometric Coefficient of Variation 225.66 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 355.86 IU/mL | Geometric Coefficient of Variation 131.08 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 12.27 IU/mL | Geometric Coefficient of Variation 67.11 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 232.72 IU/mL | Geometric Coefficient of Variation 97.53 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 16.83 IU/mL | Geometric Coefficient of Variation 279.39 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 24.54 IU/mL | Geometric Coefficient of Variation 92.01 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 1681.23 IU/mL | Geometric Coefficient of Variation 20.2 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 18.83 IU/mL | Geometric Coefficient of Variation 87.58 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 2266.65 IU/mL | Geometric Coefficient of Variation 59.16 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 660.98 IU/mL | Geometric Coefficient of Variation 91.92 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 926.48 IU/mL | Geometric Coefficient of Variation 162 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 1104.81 IU/mL | Geometric Coefficient of Variation 436.85 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 5.31 IU/mL | Geometric Coefficient of Variation 107.14 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 1751.42 IU/mL | Geometric Coefficient of Variation 544.5 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 296.69 IU/mL | Geometric Coefficient of Variation 481.82 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 497.09 IU/mL | Geometric Coefficient of Variation 542.78 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 6.65 IU/mL | Geometric Coefficient of Variation 45.13 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 601.12 IU/mL | Geometric Coefficient of Variation 797.51 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 362.53 IU/mL | Geometric Coefficient of Variation 214.09 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 459.48 IU/mL | Geometric Coefficient of Variation 1333.45 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 13.88 IU/mL | Geometric Coefficient of Variation 65.76 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 456.9 IU/mL | Geometric Coefficient of Variation 123.89 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 7.22 IU/mL | Geometric Coefficient of Variation 121.07 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 2211.08 IU/mL | Geometric Coefficient of Variation 252.38 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 948.78 IU/mL | Geometric Coefficient of Variation 219.75 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 17.42 IU/mL | Geometric Coefficient of Variation 119.26 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 597.3 IU/mL | Geometric Coefficient of Variation 216.04 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 3074.6 IU/mL | Geometric Coefficient of Variation 246.3 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 11.72 IU/mL | Geometric Coefficient of Variation 117.09 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 8.84 IU/mL | Geometric Coefficient of Variation 943.12 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 4.88 IU/mL | Geometric Coefficient of Variation 5181.02 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 6.88 IU/mL | Geometric Coefficient of Variation 3896.56 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 10.36 IU/mL | Geometric Coefficient of Variation 989.47 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 2.45 IU/mL | Geometric Coefficient of Variation 134.77 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 0.95 IU/mL | Geometric Coefficient of Variation 289.7 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 1.74 IU/mL | Geometric Coefficient of Variation 206.49 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 6.61 IU/mL | Geometric Coefficient of Variation 2278.71 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 6.28 IU/mL | Geometric Coefficient of Variation 6838.48 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 1.99 IU/mL | Geometric Coefficient of Variation 1091.74 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 7.73 IU/mL | Geometric Coefficient of Variation 3104.64 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 8.02 IU/mL | Geometric Coefficient of Variation 8352.66 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 12.37 IU/mL | Geometric Coefficient of Variation 102810.04 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 7.53 IU/mL | Geometric Coefficient of Variation 282.2 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 5.59 IU/mL | Geometric Coefficient of Variation 1429421.94 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 9.03 IU/mL | Geometric Coefficient of Variation 62605.68 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 16.64 IU/mL | Geometric Coefficient of Variation 4363.12 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 2.25 IU/mL | Geometric Coefficient of Variation 1536.33 |
Secondary
Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 7 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 6 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 3 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 2 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 1 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 7 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 2 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 7 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 2 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 26 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 4 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 6 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 1 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 1 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 2 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 42 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 8 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
Secondary
Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 8 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 7 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 2 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 1 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 2 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 2 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 1 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 8 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 1 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 1 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 6 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 2 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 1 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 31 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 1 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 5 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 1 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 1 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 41 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 2 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 7 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 1 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Change in Stage 1 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
Secondary
Change in Stage 2 Adult Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 1329.5 IU/mL | Geometric Coefficient of Variation 3501.1 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 18.28 IU/mL | Geometric Coefficient of Variation 314.85 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 812.4 IU/mL | Geometric Coefficient of Variation 6728.02 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 684.1 IU/mL | Geometric Coefficient of Variation 7400.94 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 1583.14 IU/mL | Geometric Coefficient of Variation 2496.89 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 22.14 IU/mL | Geometric Coefficient of Variation 1247.32 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 205.05 IU/mL | Geometric Coefficient of Variation 683623.84 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 311.56 IU/mL | Geometric Coefficient of Variation 120989.28 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 306.1 IU/mL | Geometric Coefficient of Variation 1263457.31 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 40.85 IU/mL | Geometric Coefficient of Variation 5113.92 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 48.64 IU/mL | Geometric Coefficient of Variation 23319.38 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 593.17 IU/mL | Geometric Coefficient of Variation 173461.3 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 127.11 IU/mL | Geometric Coefficient of Variation 3076.5 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 8464.11 IU/mL | Geometric Coefficient of Variation 216.65 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 6307.1 IU/mL | Geometric Coefficient of Variation 166.16 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 1458.9 IU/mL | Geometric Coefficient of Variation 113.83 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 1143.73 IU/mL | Geometric Coefficient of Variation 109.59 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 136.55 IU/mL | Geometric Coefficient of Variation 5462.96 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 228.43 IU/mL | Geometric Coefficient of Variation 163.73 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 701.21 IU/mL | Geometric Coefficient of Variation 193.34 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 312.05 IU/mL | Geometric Coefficient of Variation 167.64 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 1668.91 IU/mL | Geometric Coefficient of Variation 162.22 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 1030.47 IU/mL | Geometric Coefficient of Variation 203.85 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 1122.85 IU/mL | Geometric Coefficient of Variation 156.9 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 11.4 IU/mL | Geometric Coefficient of Variation 3794.97 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 3.87 IU/mL | Geometric Coefficient of Variation 933.74 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 3.83 IU/mL | Geometric Coefficient of Variation 1803.22 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 9.67 IU/mL | Geometric Coefficient of Variation 7718.35 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 7.56 IU/mL | Geometric Coefficient of Variation 4854.01 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 13.88 IU/mL | Geometric Coefficient of Variation 6077.43 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 1.24 IU/mL | Geometric Coefficient of Variation 69.04 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 0.8 IU/mL | — |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 1.17 IU/mL | Geometric Coefficient of Variation 58.88 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 0.33 IU/mL | Geometric Coefficient of Variation 144.78 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 0.15 IU/mL | — |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 0.33 IU/mL | Geometric Coefficient of Variation 145.66 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 187.34 IU/mL | Geometric Coefficient of Variation 21600.14 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 195.64 IU/mL | Geometric Coefficient of Variation 32100.88 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 137.36 IU/mL | Geometric Coefficient of Variation 5885.99 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 123.87 IU/mL | Geometric Coefficient of Variation 9374.45 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 139.71 IU/mL | Geometric Coefficient of Variation 8202.42 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 88.11 IU/mL | Geometric Coefficient of Variation 4049.13 |
Secondary
Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 7 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 2 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 3 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 8 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 4 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 5 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 3 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 44 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 2 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 2 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 18 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
Secondary
Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 2 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 7 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 2 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 2 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 7 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 5 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 2 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 46 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 3 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 2 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 1 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 19 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Change in Stage 2 Adult Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
Secondary
Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) 3 plex assay (Wu-1 full-length spike, receptor binding domain (RBD), and N proteins). Wu-1 full-length spike and RBD were used to assess vaccine response. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 1.27 IU/mL |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 6.53 IU/mL |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 2.49 IU/mL |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 10.65 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 12, Wu-1 Full-Length Spike | 3583.89 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 4, Receptor Binding Domain (RBD) | 19688.14 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 0, Receptor Binding Domain (RBD) | 175.7 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 0, Wu-1 Full-Length Spike | 123.28 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 12, Receptor Binding Domain (RBD) | 3664.63 IU/mL |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Anti-COVID-19 Antibody Response | Week 4, Wu-1 Full-Length Spike | 18473.06 IU/mL |
Secondary
Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C)
The Clinical Global Impression of Change (CGI-C) is the clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | No change | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Minimally worse | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity After Receipt of Additional Doses of COVID-19 Vaccine as Measured by the Clinical Global Impression of Change (CGI-C) | Much worse | 0 Participants |
Secondary
Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C)
The Patient Global Impression of Change (PGI-C) is the participant's global impression of their clinical condition in terms of change relative to the start of treatment. Change is rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Weeks 4 Status Post Receipt of COVID-19 Vaccine Dose
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Very much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally improved | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | No change | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Minimally worse | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Change in Stage 2 Pediatric Disease Activity as Measured by the Patient Global Impression of Change (PGI-C) | Much worse | 0 Participants |
Secondary
Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 12.31 Fold Change | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 16.7 Fold Change | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 35.78 Fold Change | Geometric Coefficient of Variation 326.98 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 85.53 Fold Change | Geometric Coefficient of Variation 101.49 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 35.32 Fold Change | Geometric Coefficient of Variation 358.06 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 65.38 Fold Change | Geometric Coefficient of Variation 165.08 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 9.3 Fold Change | — |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 3.97 Fold Change | — |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 66.34 Fold Change | Geometric Coefficient of Variation 30.51 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 85.18 Fold Change | Geometric Coefficient of Variation 53.39 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 111.83 Fold Change | — |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 99.52 Fold Change | Geometric Coefficient of Variation 168.72 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 67.9 Fold Change | Geometric Coefficient of Variation 142.36 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 80.66 Fold Change | Geometric Coefficient of Variation 115.89 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 95.54 Fold Change | Geometric Coefficient of Variation 75.93 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 2.58 Fold Change | Geometric Coefficient of Variation 257.03 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 4.99 Fold Change | Geometric Coefficient of Variation 1175.81 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 4.09 Fold Change | Geometric Coefficient of Variation 1485.84 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 1.95 Fold Change | Geometric Coefficient of Variation 86.7 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 4.48 Fold Change | — |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Fold Increase in Stage 1 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 2.91 Fold Change | — |
Secondary
Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody positive at Week 0 is defined separately for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 54.15 Fold Change | Geometric Coefficient of Variation 103.71 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 93.53 Fold Change | Geometric Coefficient of Variation 111.68 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 9.97 Fold Change | Geometric Coefficient of Variation 146.18 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 17.65 Fold Change | Geometric Coefficient of Variation 309.52 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 49.62 Fold Change | Geometric Coefficient of Variation 603.67 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 44.49 Fold Change | Geometric Coefficient of Variation 716.62 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 5.17 Fold Change | Geometric Coefficient of Variation 278.52 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 5.46 Fold Change | Geometric Coefficient of Variation 299.38 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 2.74 Fold Change | Geometric Coefficient of Variation 287.75 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 4.02 Fold Change | Geometric Coefficient of Variation 648.61 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 0.82 Fold Change | Geometric Coefficient of Variation 12.82 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Increase in Stage 2 Adult Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 0.8 Fold Change | Geometric Coefficient of Variation 10.47 |
Secondary
Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Fold increase was assessed in the subgroup of participants who were anti-COVID-19 antibody positive at Week 0; defined as having a result greater than the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Fold increase = (antibody response at Week 4)/(antibody response at Week 0).
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody positive at Week 0 were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels | Fold Change, Wu-1 Full-Length Spike | 149.84 Fold Change |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Increase in Stage 2 Pediatric Anti-COVID-19 Antibody Levels | Fold Change, Receptor Binding Domain (RBD) | 112.05 Fold Change |
Secondary
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 9.11 Fold Inhibition | Geometric Coefficient of Variation 13182.95 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 15.03 Fold Inhibition | Geometric Coefficient of Variation 154928.64 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 30 Fold Inhibition | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 18 Fold Inhibition | — |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 2 Fold Inhibition | — |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 2.99 Fold Inhibition | Geometric Coefficient of Variation 249.41 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 5.96 Fold Inhibition | Geometric Coefficient of Variation 291.28 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 3.56 Fold Inhibition | Geometric Coefficient of Variation 135.35 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1.08 Fold Inhibition | Geometric Coefficient of Variation 23.42 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 9.49 Fold Inhibition | Geometric Coefficient of Variation 577.34 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 3.46 Fold Inhibition | Geometric Coefficient of Variation 91.02 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 4.47 Fold Inhibition | Geometric Coefficient of Variation 162.84 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 1.59 Fold Inhibition | Geometric Coefficient of Variation 41.68 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 5.52 Fold Inhibition | Geometric Coefficient of Variation 255.65 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 40.15 Fold Inhibition | Geometric Coefficient of Variation 914418.24 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 5.67 Fold Inhibition | Geometric Coefficient of Variation 9124.55 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 6.16 Fold Inhibition | Geometric Coefficient of Variation 383.45 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 2.16 Fold Inhibition | Geometric Coefficient of Variation 63.89 |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 24.88 Fold Inhibition | Geometric Coefficient of Variation 2444.17 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 4.25 Fold Inhibition | Geometric Coefficient of Variation 203.12 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 1.08 Fold Inhibition | Geometric Coefficient of Variation 22.87 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 1.16 Fold Inhibition | Geometric Coefficient of Variation 38.7 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1.02 Fold Inhibition | Geometric Coefficient of Variation 10.36 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 1.55 Fold Inhibition | Geometric Coefficient of Variation 653.94 |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 1.14 Fold Inhibition | Geometric Coefficient of Variation 31.58 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 12 | 1.59 Fold Inhibition | Geometric Coefficient of Variation 94.74 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 0 | 1.09 Fold Inhibition | Geometric Coefficient of Variation 24.88 |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult Samples | Week 4 | 1.31 Fold Inhibition | Geometric Coefficient of Variation 73.48 |
Secondary
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 7.61 Fold Inhibition | Geometric Coefficient of Variation 701.06 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 23.32 Fold Inhibition | Geometric Coefficient of Variation 651.97 |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 15.31 Fold Inhibition | Geometric Coefficient of Variation 6552.75 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 1.64 Fold Inhibition | Geometric Coefficient of Variation 51.25 |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 10.34 Fold Inhibition | Geometric Coefficient of Variation 4255.15 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 5.71 Fold Inhibition | Geometric Coefficient of Variation 319.78 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 3.2 Fold Inhibition | Geometric Coefficient of Variation 9598.1 |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 109.39 Fold Inhibition | Geometric Coefficient of Variation 1119.69 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 7.34 Fold Inhibition | Geometric Coefficient of Variation 1124.11 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 1.62 Fold Inhibition | Geometric Coefficient of Variation 59.19 |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 4.03 Fold Inhibition | Geometric Coefficient of Variation 451.42 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 1.54 Fold Inhibition | Geometric Coefficient of Variation 195.75 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 1.14 Fold Inhibition | Geometric Coefficient of Variation 86.32 |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 1.43 Fold Inhibition | Geometric Coefficient of Variation 117.21 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 1 Fold Inhibition | — |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 1 Fold Inhibition | Geometric Coefficient of Variation 0 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 12 | 2.9 Fold Inhibition | Geometric Coefficient of Variation 100.15 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 4 | 6.6 Fold Inhibition | Geometric Coefficient of Variation 268.6 |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Adult Samples | Week 0 | 9.42 Fold Inhibition | Geometric Coefficient of Variation 412.99 |
Secondary
Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center (NIAID-VRC) Meso Scale Discovery (MSD) V-Plex ACE2 neutralization assay which measure antibodies that block the binding of angiotensin-converting enzyme 2 (ACE2) to the SARS-CoV-2 Spike antigens, including variants of the SARS-CoV-2 virus according to the manufacturer's instruction (MSD Catalog # K15654U). Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing anti-COVID-19 antibody response data were considered to be missing-completely-at-random. Results are reported as fold inhibition by a sample relative to signal from a 'diluent only' control (maximum ACE2 binding to antigen). Highly neutralizing samples show high fold inhibition whereas negative or low samples show low fold inhibition of ACE2 binding.
Time frame: Week 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 0 | 1 Fold Inhibition |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 4 | 1 Fold Inhibition |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 0 | 1 Fold Inhibition |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 4 | 722 Fold Inhibition |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Fold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 2 Pediatric Samples | Week 12 | 158 Fold Inhibition |
Secondary
Percentage of Stage 1 Adult Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative (by either Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 2 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 2 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 2 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 2 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 3 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 3 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 1 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 3 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 2 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 2 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 3 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 3 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 2 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 13 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 12 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 10 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 12 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 2 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percentage of Stage 1 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
Secondary
Percentage of Stage 2 Adult Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or COVID-19 vaccine given off-study were excluded from the analyses. Participants missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858). Anti-COVID-19 antibody negative at Week 0 is defined separately for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative (by Wu-1 full-length spike or RBD) at Week 0 were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 1 Participants |
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 7 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 4 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Receptor Binding Domain (RBD) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percentage of Stage 2 Adult Participants Who Seroconverted | Seroconverted, Wu-1 Full-Length Spike | 0 Participants |
Secondary
Percentage of Stage 2 Pediatric Participants Who Seroconverted
Antibody response was measured using the National Institute of Allergy and Infectious Disease Vaccine Research Center Meso Scale Discovery 3 plex assay. For concentrations below the lower limit of detection (LLOD), numeric values equivalent to LLOD/2 were assigned; concentrations above the upper limit of quantification were reported without adjustments. Antibody results collected after a documented COVID-19 infection, monoclonal antibody use, or a COVID-19 vaccine given off-study were excluded from the analyses. Participants with missing antibody data were considered missing-completely-at-random. Seroconversion was assessed in the subgroup of participants who were anti-COVID-19 antibody negative at Week 0; defined as a result less than or equal to the positive threshold value (spike=10.8424, RBD=14.0858), defined independently for spike and RBD. Seroconversion was defined as having a result greater than the positive threshold at the Week 4 visit.
Time frame: Week 4 Status Post Receipt of COVID-19 Vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study. Only participants who were anti-COVID-19 antibody negative at Week 0 were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percentage of Stage 2 Pediatric Participants Who Seroconverted | 0 Participants |
Secondary
Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 5 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 1 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
Secondary
Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
Secondary
Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 5 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
Secondary
Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 5 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 4 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
Efficacy measure.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 3 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 3 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 1 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |
| Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 3 Participants |
| Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 6 Participants |
| Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 14 Participants |
| Cohort C, Arm C2: Pfizer-BioNTech + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 12 Participants |
| Cohort C, Arm C3: Janssen + Continue IS (BCDT) | Percent of Stage 1 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 6 Participants |
Secondary
Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 2 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 1 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 4 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
Secondary
Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
Secondary
Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 2 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 1 Participants |
Secondary
Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 6 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 2 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 1 Participants |
| Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 1 Participants |
| Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 3 Participants |
| Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 20 Participants |
| Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |
| Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX) | Percent of Stage 2 Adult Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 6 Participants |
Secondary
Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
All unsolicited adverse events (AEs) (all grades) were collected from Day 1 through Day 28; solicited AEs were collected if they were ongoing at Day 7 (post vaccination); any flares of a secondary autoimmune disease, serious AEs, medically attended AEs, new onset chronic medical conditions, and COVID-19 infections were collected from Day 1 through the end of the participant's study participation. All AEs were classified by system organ class (SOC) and preferred term, according to a standardized thesaurus (Medical Dictionary for Regulatory Activities \[MedDRA\] version 24.0. Related AEs were defined as possibly related (the AE has a reasonable possibility to be related; there is evidence to suggest a causal relationship) or related (the adverse event is clearly related). Severity was assessed according to the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 5.0.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine | 0 Participants |
Secondary
Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Medically attended adverse event (MAAE) is defined as a hospitalization, emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason that is considered possibly related or related to study vaccine.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs) | 0 Participants |
Secondary
Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
A new onset chronic medical condition (NOCMC) is defined as any new ICD diagnosis (per current International Statistical Classification of Diseases and Related Health Problems) that is applied to the study participant during the course of the study, after receipt of the vaccine, that is expected to continue for at least 3 months and requires continued health care intervention.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs) | 0 Participants |
Secondary
Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs)
An event is considered serious if, in the view of either the investigator or Sponsor, it results in any of the following: 1. Death. 2. Life-threatening event: considered life-threatening if, in the view of either the investigator or Sponsor, its occurrence places the participant at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death. 3. Inpatient hospitalization or prolongation of existing hospitalization. 4. Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital anomaly or birth defect. 6. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
COVID-19 infections (all grades) were confirmed by molecular COVID-19 testing. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 24.0.
Time frame: Up to Week 48 post study vaccination
Population: The vaccinated population includes all participants who were allocated and received study vaccine in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |
| Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA) | Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection | 0 Participants |