Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000661875
Ethics application status
Approved
Date submitted
20/05/2021
Date registered
1/06/2021
Date last updated
27/08/2021
Date data sharing statement initially provided
1/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antibody response to COVID-19 vaccination in immunosuppressed patients with autoimmune disease
Scientific title
Antibody response to COVID-19 vaccination in immunosuppressed patients with autoimmune disease
Secondary ID [1] 304257 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RESCUE
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 321975 0
Psoriatic arthritis 321976 0
Ankylosing spondylitis 321977 0
Crohn's Disease 321978 0
Ulcerative Colitis 321979 0
COVID-19 322019 0
Inflammatory bowel disease 322020 0
Condition category
Condition code
Inflammatory and Immune System 319700 319700 0 0
Autoimmune diseases
Oral and Gastrointestinal 319739 319739 0 0
Crohn's disease
Oral and Gastrointestinal 319740 319740 0 0
Inflammatory bowel disease
Musculoskeletal 319741 319741 0 0
Other muscular and skeletal disorders
Infection 319742 319742 0 0
Other infectious diseases
Inflammatory and Immune System 319743 319743 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 319770 319770 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are planning to have the COVID-19 vaccination will be followed. Patients having the AstraZenca vaccine will have the vaccination at weeks 0 and 12, while the patients receiving the Pfizer vaccination will receive it on weeks 0 and 4. The vaccinations will be provided by their general practitioner. Records from their GP or from My Health Record will be obtained to confirm vaccine administration. The only intervention is some patients will be randomly assigned to withhold their immunosuppressive medications for 1 week after the first vaccine dose only.

There are no adherence measures implemented to confirm if patients a compliant to the instructions of continuing or withholding their medication. A member of the research team will instruct the patient which arm they have been assigned to.

Intervention code [1] 320596 0
Treatment: Other
Intervention code [2] 320629 0
Treatment: Drugs
Comparator / control treatment
Healthy individuals not on immunosuppressive therapy will receive either the Pfizer or Astra Zeneca vaccine.
Control group
Active

Outcomes
Primary outcome [1] 327579 0
Antibody response to the Pfizer/BioNTech COVID-19 mRNA vaccine BNT162b2 using the COVID-19 total and IgG Siemens panel
Timepoint [1] 327579 0
Weeks 4 & 8 (primary timepoints) and 24
Primary outcome [2] 327629 0
Antibody response to the Oxford/Astra Zeneca (ChAdOx1nCov-19) using the COVID-19 total and IgG Siemens panel
Timepoint [2] 327629 0
Weeks 4 & 16 (primary timepoints) and 24
Secondary outcome [1] 395719 0
Exploratory outcome looking at the cytokine levels in the post vaccination period assessed using plasma multiplex assay for the Pfizer/BioNTech COVID-19 mRNA vaccine.
Timepoint [1] 395719 0
4 weeks after 1st vaccine dose
Secondary outcome [2] 395989 0
Exploratory outcome looking at the cytokine levels in the post vaccination period assessed using plasma multiplex assay for the Oxford/Astra Zeneca (ChAdOx1nCov-19) vaccine.
Timepoint [2] 395989 0
4 weeks post vaccination

Eligibility
Key inclusion criteria
• 18 years or older
• Have an autoimmune rheumatic disease or inflammatory bowel disease
• Treated and stable on immunosuppressive therapy
- Patients who do not have an autoimmune disorder and are not on immunosuppressive therapy will be included as a healthy volunteer cohort
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Prior vaccination to COVID-19
• Previous history of COVID-19 infection
• Recent prednisolone use within 4 weeks of COVID-19 vaccination
• Inability to have the COVID-19 vaccine
• Previous life threatening or end organ disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Shapiro-Wilk test and student T-test or non-parametric test will be used to investigate the differences in immune antibody response between the different study groups. In addition covariate analyses or logistical regression will be used to determine whether variables such as age, sex, BMI, vaccine type, smoking or current therapies have an effect on immune status. A p-value of <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 19472 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [2] 19473 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34066 0
6150 - Murdoch
Recruitment postcode(s) [2] 34067 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 308637 0
Self funded/Unfunded
Name [1] 308637 0
Dr Ai Tran
Country [1] 308637 0
Australia
Primary sponsor type
Individual
Name
Dr Ai Tran
Address
Wexford Medical Centre
Suite 29, 3 Barry Marshall Parade
Murdoch, WA 6150
Country
Australia
Secondary sponsor category [1] 309508 0
None
Name [1] 309508 0
Address [1] 309508 0
Country [1] 309508 0
Other collaborator category [1] 281787 0
Individual
Name [1] 281787 0
Asoc Prof Nik Ding
Address [1] 281787 0
St Vincent's Hospital Melbourne 41 Victoria Parade Fitzroy VIC 3065
Country [1] 281787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308563 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 308563 0
Ethics committee country [1] 308563 0
Australia
Date submitted for ethics approval [1] 308563 0
06/04/2021
Approval date [1] 308563 0
14/04/2021
Ethics approval number [1] 308563 0
1809

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111150 0
Dr Ai Tran
Address 111150 0
Wexford Medical Centre Suite 29, 3 Barry Marshall Parade Murdoch, WA 6150
Country 111150 0
Australia
Phone 111150 0
+61410786007
Fax 111150 0
+61893322005
Email 111150 0
[email protected]
Contact person for public queries
Name 111151 0
Ai Tran
Address 111151 0
Wexford Medical Centre Suite 29, 3 Barry Marshall Parade Murdoch, WA 6150
Country 111151 0
Australia
Phone 111151 0
+61893322004
Fax 111151 0
+61893322005
Email 111151 0
[email protected]
Contact person for scientific queries
Name 111152 0
Ai Tran
Address 111152 0
Wexford Medical Centre Suite 29, 3 Barry Marshall Parade Murdoch, WA 6150
Country 111152 0
Australia
Phone 111152 0
+61893322004
Fax 111152 0
+61893322005
Email 111152 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data of published results only

What types of analyses could be done with individual participant data?
• for IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11717Ethical approval    Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAntibody response to the COVID-19 ChAdOx1nCov-19 and BNT162b vaccines after temporary suspension of DMARD therapy in immune-mediated inflammatory disease (RESCUE).2022https://dx.doi.org/10.1136/rmdopen-2022-002301
EmbaseCOVID-19 phase 4 vaccine candidates, effectiveness on SARS-CoV-2 variants, neutralizing antibody, rare side effects, traditional and nano-based vaccine platforms: a review.2022https://dx.doi.org/10.1007/s13205-021-03076-0
N.B. These documents automatically identified may not have been verified by the study sponsor.