Terminated PHASE2 INTERVENTIONAL 43-arm NCT05000216

COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders

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

Sponsor: Autoimmunity Centers of Excellence

Conditions Juvenile Dermatomyositis (JDM) Juvenile Idiopathic Arthritis (JIA) Multiple Sclerosis (MS) Pediatric SLE Pediatric-Onset Multiple Sclerosis (POMS) Pemphigus Vulgaris Rheumatoid Arthritis (RA) Systemic Lupus Erythematosus (SLE) Systemic Sclerosis (SSc)

Interventions Ad26.COV2.S BNT162b2 BNT162b2, Bivalent Continue IS (B cell depletion therapy) Continue IS (MMF or MPA) Continue IS (MTX) Moderna mRNA-1273 Moderna mRNA-1273, Bivalent Monovalent [B.1.351] CoV2 preS dTM-AS03 Withhold IS (B cell depletion therapy) Withhold IS (MMF or MPA) Withhold IS (MTX)

Updated 20 times since 2021 Last updated: Aug 4, 2025 Started: Aug 13, 2021 Primary completion: Jun 22, 2023 Completion: Mar 28, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study was closed due to continued enrollment hurdles.

Other terminated trials from Autoimmunity Centers of Excellence

See all terminations from Autoimmunity Centers of Excellence

Listed as NCT05000216, this PHASE2 trial focuses on Juvenile Dermatomyositis (JDM) and Juvenile Idiopathic Arthritis (JIA) and remains terminated or withdrawn. Sponsored by Autoimmunity Centers of Excellence, it has been updated 20 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

20 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE2

Status: Completed → Terminated
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
May 2024 — Jul 2024 [monthly]

Completed PHASE2

Status: Active Not Recruiting → Completed
Apr 2024 — May 2024 [monthly]

Active Not Recruiting PHASE2

▶ Show 15 earlier versions

Feb 2024 — Apr 2024 [monthly]

Active Not Recruiting PHASE2
Sep 2023 — Feb 2024 [monthly]

Active Not Recruiting PHASE2
Aug 2023 — Sep 2023 [monthly]

Active Not Recruiting PHASE2
Jun 2023 — Aug 2023 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
May 2023 — Jun 2023 [monthly]

Recruiting PHASE2
Apr 2023 — May 2023 [monthly]

Recruiting PHASE2
Dec 2022 — Apr 2023 [monthly]

Recruiting PHASE2
Sep 2022 — Dec 2022 [monthly]

Recruiting PHASE2
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE2
Jun 2022 — Jul 2022 [monthly]

Recruiting PHASE2
Apr 2022 — Jun 2022 [monthly]

Recruiting PHASE2
Jan 2022 — Apr 2022 [monthly]

Recruiting PHASE2
Nov 2021 — Jan 2022 [monthly]

Recruiting PHASE2
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE2
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE2

First recorded

Aug 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Autoimmunity Centers of Excellence
National Institute of Allergy and Infectious Diseases (NIAID)
Rho Federal Systems Division, Inc.

Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Boston, United States , Chapel Hill, United States , Charleston, United States , Cleveland, United States , Columbus, United States , Dallas, United States , Durham, United States , Houston, United States and 11 more locations