Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001211459
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
14/10/2025
Date registered
Help: Date registered
3/11/2025
Date last updated
Help: Date last updated
3/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
3/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Immune Effects of Respiratory Syncytial Virus (RSV) Vaccination in Older Adults
Scientific title
Antibody and cellular responses to Arexvy or Abrysvo RSV Vaccination in Older Adults
Additional trial identifiers [1] 315578 0
None
Universal Trial Number (UTN)
Trial acronym
REVULPOP
Related trial records

Health condition
Health condition(s) studied:
Response to vaccination 339213 0
Depression 339215 0
Anxiety 339216 0
Stress 339217 0
Condition category
Condition code
Inflammatory and Immune System 335492 335492 0 0
Normal development and function of the immune system
Mental Health 335494 335494 0 0
Depression
Mental Health 335495 335495 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Randomised to receive a single 0.5mL dose intramuscularly of the Arexvy RSV vaccine. The vaccine will be administered by a research nurse who will not be directly supervised but will document the vaccine given in the CRF.
Intervention code [1] 332281 0
Prevention
Description of the comparator or control
A single 0.5mL dose intramuscularly of Abrysvo RSV vaccine. The vaccine will be administered by a research nurse who will not be directly supervised but will document the vaccine given in the CRF.
Control group
Active

Outcomes
Primary outcome [1] 343044 0
Change in antibody response
Timepoint [1] 343044 0
4 weeks post-vaccination
Primary outcome [2] 343045 0
Change in T cell response
Timepoint [2] 343045 0
4 weeks post-vaccination
Secondary outcome [1] 453248 0
Change in gene expression
Timepoint [1] 453248 0
24 hours post-vaccination
Secondary outcome [2] 453249 0
Change in innate immune cell subsets
Timepoint [2] 453249 0
1 week and 4 weeks post-vaccination
Secondary outcome [3] 453251 0
Change in plasma epigenetic marks
Timepoint [3] 453251 0
1 week, 4 weeks, 12 months post-vaccination
Secondary outcome [4] 453252 0
Change in plasma lipidome
Timepoint [4] 453252 0
24 hours, 1 week, 4 weeks post-vaccination
Secondary outcome [5] 453253 0
Change in plasma metabolome
Timepoint [5] 453253 0
24 hours, 1 week, 4 weeks post-vaccination
Secondary outcome [6] 453254 0
Change in the Edinburgh Postnatal Depression Scale Score
Timepoint [6] 453254 0
1 week, 4 weeks and 12 months post-vaccination
Secondary outcome [7] 453255 0
Change in the depression and anxiety composite score
Timepoint [7] 453255 0
1 week, 4 weeks and 12 months post-vaccination
Secondary outcome [8] 453256 0
Change in immune cell epigenetic profile
Timepoint [8] 453256 0
week, 4 weeks, 12 months post-vaccination
Secondary outcome [9] 453257 0
Change in antibody response
Timepoint [9] 453257 0
12 months post-vaccination
Secondary outcome [10] 453258 0
Change in T cell response
Timepoint [10] 453258 0
12 months post-vaccination
Secondary outcome [11] 453259 0
Change in adaptive immune cell subsets
Timepoint [11] 453259 0
1 weeks and 4 weeks post-vaccination

Eligibility
Key inclusion criteria
Men and women aged 60 years and older with or without co-morbidities.
Ability to communicate in English.
Ability to communicate by mobile telephone and text messaging.
Written informed consent to participate in the trial.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Known allergy or contraindication to Abrysvo or Arexvy RSV vaccination.
Unlikely to be available for the duration of the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
The main aim of this study is to use a systems vaccinology approach to explore the broad immunological effects of the two RSV vaccines. It is exploratory and will analyse for multiple factors. The power calculations are based on our previous published transcriptomic studies where >100 combined males and females have provided significant post-vaccination RNA signatures when analysed separately by sex.
Primary statistical analyses will take place after all subjects have had their 4-week post-vaccination assessment. Repeated antibody, T cell and other categorical variables will be analysed by fitting linear mixed models. The F-test will be used to test for interactions with effect of time. The systems vaccinology ‘omics’ analyses require a highly complex bioinformatics analysis approach using proprietary software and bioinformatics expertise.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/01/2026
Actual
Date of last participant enrolment
Anticipated
20/12/2027
Actual
Date of last data collection
Anticipated
29/12/2028
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 28645 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 44874 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 320180 0
Charities/Societies/Foundations
Name [1] 320180 0
Clifford Craig Foundation
Country [1] 320180 0
Australia
Primary sponsor type
Government body
Name
Tasmanian Health Service
Address
Country
Australia
Secondary sponsor category [1] 322740 0
None
Name [1] 322740 0
Address [1] 322740 0
Country [1] 322740 0
Other collaborator category [1] 283708 0
University
Name [1] 283708 0
Royal Melbourne Institute of Technology University
Address [1] 283708 0
Country [1] 283708 0
Australia
Other collaborator category [2] 283709 0
University
Name [2] 283709 0
University of Tasmania
Address [2] 283709 0
Country [2] 283709 0
Australia
Other collaborator category [3] 283710 0
University
Name [3] 283710 0
The Hudson Institute, Monash University
Address [3] 283710 0
Country [3] 283710 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318718 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 318718 0
Ethics committee country [1] 318718 0
Australia
Date submitted for ethics approval [1] 318718 0
06/01/2025
Approval date [1] 318718 0
28/02/2025
Ethics approval number [1] 318718 0
H0026241

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

Contacts
Principal investigator
Name 145050 0
Prof Katie Flanagan
Address 145050 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead, Sydney, NSW 2145
Country 145050 0
Australia
Phone 145050 0
+61 0429933111
Fax 145050 0
Email 145050 0
[email protected]
Contact person for public queries
Name 145051 0
Monika O'Connor
Address 145051 0
Research Centre, 1st Floor, Northern Integrated Care Services, 41 Frankland Street, Launceston TAS 7250
Country 145051 0
Australia
Phone 145051 0
+61 0474516022
Fax 145051 0
Email 145051 0
[email protected]
Contact person for scientific queries
Name 145052 0
Katie Flanagan
Address 145052 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead, Sydney, NSW 2145
Country 145052 0
Australia
Phone 145052 0
+61 0429933111
Fax 145052 0
Email 145052 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: By application to [email protected] or [email protected] who will provide an application form for consideration by the Biobank Management Committee. This can be for access to data or the study biospecimens.

Are there extra considerations when requesting access to individual participant data?
Yes: Subject to a data transfer agreement after the scientific merit has been approved by the Biobank Mangement Committee.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    H0026241 Tas HREC Approval Letter 28Feb25.pdf


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.