Arm 2 (co-administration group) for Rheumatic Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Oregon Health & Science University, Portland, OR
Rheumatic Diseases+1 More
Diphtheria, pertussis, and tetanus booster vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help to better understand the immunogenicity and safety of the Pfizer-BioNTech and Moderna COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Patients in Arm 2 will receive the study drug and an active comparator drug to treat their Rheumatic Disease.

Eligible Conditions

  • Rheumatic Diseases

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Rheumatic Diseases

Study Objectives

23 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Number of confirmed cases of COVID-19 (Arm 2 to Arm 1)
Number of confirmed cases of COVID-19 (Arm 3 to Arm 1)
Number of confirmed cases of COVID-19 (Arm 4 to Arm 1)
Number of medically attended events (Arm 2 to Arm 1)
Number of medically attended events (Arm 3 to Arm 1)
Number of medically attended events (Arm 4 to Arm 1)
Number of participants with solicited localized and general symptoms (Arm 2 to Arm 1)
Number of participants with solicited localized and general symptoms (Arm 3 to Arm 1)
Number of participants with solicited localized and general symptoms (Arm 4 to Arm 1)
Number of participants with unsolicited events (Arm 2 to Arm 1)
Number of participants with unsolicited events (Arm 3 to Arm 1)
Number of participants with unsolicited events (Arm 4 to Arm 1)
Number of potential immune-mediated diseases (Arm 2 to Arm 1)
Number of potential immune-mediated diseases (Arm 3 to Arm 1)
Number of potential immune-mediated diseases (Arm 4 to Arm 1)
Number of serious adverse events (Arm 2 to Arm 1)
Number of serious adverse events (Arm 3 to Arm 1)
Number of serious adverse events (Arm 4 to Arm 1)
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a hepA vaccination co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received a tdap booster co-administered with the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a hepA vaccination co-administered with the SARS-CoV-2 booster.
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a tdap booster co-administered with the SARS-CoV-2 booster.
Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 measured post-vaccination for those who received only the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Rheumatic Diseases

Trial Design

4 Treatment Groups

Arm 2 (co-administration group)
1 of 4
Arm 1 (control group, sequential administration)
1 of 4
Arm 3 (co-administration group)
1 of 4
Arm 4 (Inflammatory arthritis patients using DMARDS)
1 of 4
Active Control

400 Total Participants · 4 Treatment Groups

Primary Treatment: Arm 2 (co-administration group) · No Placebo Group · Phase 4

Arm 2 (co-administration group)
Biological
ActiveComparator Group · 1 Intervention: Hepatitis A vaccine · Intervention Types: Biological
Arm 1 (control group, sequential administration)ActiveComparator Group · 2 Interventions: Diphtheria, pertussis, and tetanus booster vaccine, Hepatitis A vaccine · Intervention Types: Biological, Biological
Arm 3 (co-administration group)
Biological
ActiveComparator Group · 1 Intervention: Diphtheria, pertussis, and tetanus booster vaccine · Intervention Types: Biological
Arm 4 (Inflammatory arthritis patients using DMARDS)NoIntervention Group · 1 Intervention: Arm 4 (Inflammatory arthritis patients using DMARDS) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Oregon Health & Science University · Portland, OR
Photo of Portland 1Photo of Portland 2Photo of Portland 3
2013First Recorded Clinical Trial
1 TrialsResearching Rheumatic Diseases
570 CompletedClinical Trials

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
880 Previous Clinical Trials
6,826,407 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must meet all of the inclusion criteria at the time of screening.
You must be at least 18 years of age to participate in this study.
Patients in the Co-administration arms (arms 2 and 3) must meet ACIP recommendations for the use of HAVRIX® (i.e

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.