Arm 2 (co-administration group) for Rheumatic Diseases
Phase-Based Progress Estimates
Effectiveness
Safety
Oregon Health & Science University, Portland, OR
Rheumatic Diseases+1 More
Diphtheria, pertussis, and tetanus booster vaccine - BiologicalEligibility
18+
All Sexes
What conditions do you have?
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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
This is further along than 93% of similar trials
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
This is further along than 85% of similar trials
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: BiologicalArm 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: BiologicalArm 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
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 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.
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