Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001159448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
31/07/2025
Date registered
Help: Date registered
23/10/2025
Date last updated
Help: Date last updated
23/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
23/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Immune Effects of Respiratory Syncytial Virus (RSV) Vaccination in Pregnant Women
Scientific title
Antibody and cellular responses to Arexvy RSV Vaccination in Pregnant Women
Additional trial identifiers [1] 315041 0
None
Universal Trial Number (UTN)
Trial acronym
REVULPOP
Related trial records

Health condition
Health condition(s) studied:
Response to vaccination 338390 0
Depression 338932 0
Anxiety 339211 0
Stress 339212 0
Condition category
Condition code
Inflammatory and Immune System 334696 334696 0 0
Normal development and function of the immune system
Diet and Nutrition 334698 334698 0 0
Other diet and nutrition disorders
Mental Health 334699 334699 0 0
Depression
Mental Health 335230 335230 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
A single 0.5 mL dose of Abrysvo RSV vaccine administered by intramuscular injection from 28 weeks' gestation. This vaccine is offered to all pregnant women whether they participate in the trial or not, but we will recruit those who agree to vaccination and wish to participate in the trial.
Intervention code [1] 331643 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342361 0
Change in antibody response
Timepoint [1] 342361 0
4 weeks post-vaccination
Primary outcome [2] 342362 0
Change in T cell response
Timepoint [2] 342362 0
4 weeks post-vaccination
Secondary outcome [1] 450502 0
Change in gene expression
Timepoint [1] 450502 0
24 hours post-vaccination
Secondary outcome [2] 450503 0
Change in innate immune cell subsets
Timepoint [2] 450503 0
1 week and 4 weeks post-vaccination
Secondary outcome [3] 450504 0
Change in plasma epigenetic marks
Timepoint [3] 450504 0
1 week, 4 weeks, 12 months post-vaccination
Secondary outcome [4] 450505 0
Change in plasma lipidome
Timepoint [4] 450505 0
24 hours, 1 week, 4 weeks post-vaccination
Secondary outcome [5] 450506 0
Change in plasma metabolome
Timepoint [5] 450506 0
24 hours, 1 week, 4 weeks post-vaccination
Secondary outcome [6] 450507 0
Change in the Edinburgh Postnatal Depression Scale Score
Timepoint [6] 450507 0
1 week, 4 weeks and 12 months post-vaccination
Secondary outcome [7] 450508 0
Change in the depression and anxiety composite score
Timepoint [7] 450508 0
1 week, 4 weeks and 12 months post-vaccination
Secondary outcome [8] 450509 0
Change in immune cell epigenetic profile
Timepoint [8] 450509 0
1 week, 4 weeks, 12 months post-vaccination
Secondary outcome [9] 452324 0
Change in antibody response
Timepoint [9] 452324 0
12 months post-vaccination
Secondary outcome [10] 452325 0
Change in T cell response
Timepoint [10] 452325 0
12 months post-vaccination
Secondary outcome [11] 452534 0
Change in adaptive immune cell subsets
Timepoint [11] 452534 0
1 weeks and 4 weeks post-vaccination

Eligibility
Key inclusion criteria
Pregnant.
Aged 18 years and above.
Healthy uncomplicated pregnancy at 28 weeks' gestation or more.
Ability to communicate in English.
Ability to communicate by mobile telephone and text messaging.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
<18 years old.
Less that 28 weeks' gestation.
Inability to speak and/or understand English.
Inability to provide informed consent.
Known allergy or contraindication to Abrysvo RSV vaccination.
Unwilling to give consent to participate.
Unlikely to be available for the duration of the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The main aim of this study is to use a systems vaccinology approach to explore the broad immunological effects of vaccination. It is exploratory and will analyse for multiple factors. The power calculations are based on our previous published transcriptomic studies where 50 individuals have provided post-vaccination RNA signatures.
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
3/11/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
14/01/2028
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 28269 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 44481 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 319603 0
Charities/Societies/Foundations
Name [1] 319603 0
Clifford Craig Foundation
Country [1] 319603 0
Australia
Primary sponsor type
Government body
Name
Tasmanian Health Service
Address
Country
Australia
Secondary sponsor category [1] 322108 0
None
Name [1] 322108 0
Address [1] 322108 0
Country [1] 322108 0
Other collaborator category [1] 283608 0
University
Name [1] 283608 0
RMIT University
Address [1] 283608 0
Country [1] 283608 0
Australia
Other collaborator category [2] 283609 0
University
Name [2] 283609 0
University of Tasmania
Address [2] 283609 0
Country [2] 283609 0
Australia
Other collaborator category [3] 283610 0
University
Name [3] 283610 0
The Hudson Institute, Monash University
Address [3] 283610 0
Country [3] 283610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318168 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 318168 0
Ethics committee country [1] 318168 0
Australia
Date submitted for ethics approval [1] 318168 0
06/01/2025
Approval date [1] 318168 0
28/02/2025
Ethics approval number [1] 318168 0
H0026241

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

Contacts
Principal investigator
Name 143334 0
Prof Katie Flanagan
Address 143334 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead, Sydney, NSW 2145
Country 143334 0
Australia
Phone 143334 0
+61 0429933111
Fax 143334 0
Email 143334 0
[email protected]
Contact person for public queries
Name 143335 0
Monika O'Connor
Address 143335 0
Research Centre, 1st Floor, Northern Integrated Care Services, 41 Frankland Street, Launceston TAS 7250
Country 143335 0
Australia
Phone 143335 0
+61 3 6777 6010
Fax 143335 0
Email 143335 0
[email protected]
Contact person for scientific queries
Name 143336 0
Katie Flanagan
Address 143336 0
Westmead Hospital, Cnr Hawkesbury Road and, Darcy Rd, Westmead, Sydney, NSW 2145
Country 143336 0
Australia
Phone 143336 0
+61 2 8890 5264
Fax 143336 0
Email 143336 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: [email protected]

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


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.