ConductScience.org, home

Trial ยท NCT05000216

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

NCT05000216, Phase 2, Terminated, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-08-22

3 sourcestrials-2026-11-12-0.5.0

Download JSON
Cite this record

ConductScience Library. COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders. Trials, record NCT05000216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05000216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
NCT number
NCT05000216
Status
Terminated
Phases
Phase 2
Enrollment
258 participants, actual
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS), Systemic Sclerosis (SSc), Pediatric SLE, Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), Pediatric-Onset Multiple Sclerosis (POMS)
Interventions
Moderna mRNA-1273, BNT162b2, Ad26.COV2.S, Continue IS (MMF or MPA), Continue IS (MTX), Continue IS (B cell depletion therapy), Monovalent [B.1.351] CoV2 preS dTM-AS03, Withhold IS (MMF or MPA), Withhold IS (MTX), Withhold IS (B cell depletion therapy), Moderna mRNA-1273, Bivalent, BNT162b2, Bivalent
First posted
2021-08-11
Last updated
2026-06-10
Results first posted
2025-08-22
Limitations and caveats
The trial was closed prior to fully enrolling because of slow enrollment due to increasing infections in the general population with resulting elevated antibody titers, changing CDC vaccination recommendations, and vaccine hesitancy. Original enrollment goals were 60 participants per arm.

Source ClinicalTrials.gov

Registered outcomes58

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPercent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Week 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.
PrimaryPercent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4Week 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.
PrimaryPercent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4Week 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.
SecondaryPercentage of Stage 1 Adult Participants Who SeroconvertedWeek 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.
SecondaryPercentage of Stage 2 Adult Participants Who SeroconvertedWeek 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.
SecondaryFold Increase in Stage 1 Adult Anti-COVID-19 Antibody LevelsWeek 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).
SecondaryFold Increase in Stage 2 Adult Anti-COVID-19 Antibody LevelsWeek 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).
SecondaryChange in Stage 1 Adult Anti-COVID-19 Antibody ResponseWeek 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.
SecondaryChange in Stage 2 Adult Anti-COVID-19 Antibody ResponseWeek 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.
SecondaryFold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult SamplesWeek 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.

Outcomes58

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Week 4 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.Percentage of participantsNUMBER
PRIMARYPercent of Stage 2 Adult Participants Who Have a Protective Antibody Response at Week 4Week 4 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were allocated and received study vaccine in the study.Percentage of participantsNUMBER
PRIMARYPercent of Stage 2 Pediatric Participants Who Have a Protective Antibody Response at Week 4Week 4 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were allocated and received study vaccine in the study.Percentage of participantsNUMBER
SECONDARYPercentage of Stage 1 Adult Participants Who SeroconvertedWeek 4 Status Post Receipt of COVID-19 Vaccination
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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Stage 2 Adult Participants Who SeroconvertedWeek 4 Status Post Receipt of COVID-19 Vaccination
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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYFold Increase in Stage 1 Adult Anti-COVID-19 Antibody LevelsWeek 4 Status Post Receipt of COVID-19 Vaccination
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.
Fold ChangeGEOMETRIC_MEAN
SECONDARYFold Increase in Stage 2 Adult Anti-COVID-19 Antibody LevelsWeek 4 Status Post Receipt of COVID-19 Vaccination
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.
Fold ChangeGEOMETRIC_MEAN
SECONDARYChange in Stage 1 Adult Anti-COVID-19 Antibody ResponseWeek 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.IU/mLGEOMETRIC_MEAN
SECONDARYChange in Stage 2 Adult Anti-COVID-19 Antibody ResponseWeek 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were allocated and received study vaccine in the study.IU/mLGEOMETRIC_MEAN
SECONDARYFold Inhibition of ACE2 Binding to SARS-CoV-2 Variant Antigens by Stage 1 Adult SamplesWeek 0 and Weeks 4 and 12 Status Post Receipt of COVID-19 VaccinationThe vaccinated population includes all participants who were randomized or allocated and received study vaccine in the study.Fold InhibitionGEOMETRIC_MEAN

Results by group1,047

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants
Percent of Stage 1 Adult Participants Who Have a Protective Antibody Response at Week 4Cohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)Week 4, Wu-1 Full-Length SpikeNAPercentage of participants

Participant flow198

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Stage 1STARTEDCohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)2
Stage 1STARTEDCohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)2
Stage 1STARTEDCohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)9
Stage 1STARTEDCohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)10
Stage 1STARTEDCohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)2
Stage 1STARTEDCohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)3
Stage 1STARTEDCohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)3
Stage 1STARTEDCohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)11
Stage 1STARTEDCohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)11
Stage 1STARTEDCohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)41

Adverse events882

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherTachycardiaCardiac disordersCohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)020
otherTachycardiaCardiac disordersCohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)010
otherTachycardiaCardiac disordersCohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)181
otherTachycardiaCardiac disordersCohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)090
otherTachycardiaCardiac disordersCohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)020
otherTachycardiaCardiac disordersCohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)030
otherTachycardiaCardiac disordersCohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)030
otherTachycardiaCardiac disordersCohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)0100
otherTachycardiaCardiac disordersCohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)0100
otherTachycardiaCardiac disordersCohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)0400

Adverse event totals63

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCohort A, Arm A1: Moderna mRNA-1273 + Continue IS (MMF or MPA)02
Total, all-cause mortalityCohort A, Arm A4: Moderna mRNA-1273 + Withhold IS (MMF or MPA)01
Total, all-cause mortalityCohort A, Arm A2: Pfizer-BioNTech + Continue IS (MMF or MPA)08
Total, all-cause mortalityCohort A, Arm A5: Pfizer-BioNTech + Withhold IS (MMF or MPA)09
Total, all-cause mortalityCohort A, Arm A6: Janssen + Withhold IS (MMF or MPA)02
Total, all-cause mortalityCohort B, Arm B1: Moderna mRNA-1273 + Continue IS (MTX)03
Total, all-cause mortalityCohort B, Arm B4: Moderna mRNA-1273 + Withhold IS (MTX)03
Total, all-cause mortalityCohort B, Arm B2: Pfizer-BioNTech + Continue IS (MTX)010
Total, all-cause mortalityCohort B, Arm B5: Pfizer-BioNTech + Withhold IS (MTX)010
Total, all-cause mortalityCohort C, Arm C1: Moderna mRNA-1273 + Continue IS (BCDT)040

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
41289027DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) vs Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX): Percent of Stage 2 Pediatric Participants Who Experience Any Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection
Trial comparisons
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) vs Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX): Percent of Stage 2 Pediatric Participants Who Experience Any Grade 1 or Higher Adverse Events Related to Study Vaccine
Trial comparisons
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) vs Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX): Percent of Stage 2 Pediatric Participants Who Experience Any New Onset Chronic Medical Conditions (NOCMCs)
Trial comparisons
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) vs Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX): Percent of Stage 2 Pediatric Participants Who Experience Any Medically Attended Adverse Events (MAAEs)
Trial comparisons
Cohort D, Arm D2P: Moderna mRNA-1273 + Withhold IS (MMF/MPA) vs Cohort E, Arm E2P: Moderna mRNA-1273 + Withhold IS (MTX): Percent of Stage 2 Pediatric Participants Who Experience Any Serious Adverse Events (SAEs)
Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05000216

GET https://conductscience.org/api/trials/v1/NCT05000216/registered?page=2