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Immune Effects of Respiratory Syncytial Virus (RSV) Vaccination in Pregnant Women

Antibody and cellular responses to Arexvy RSV Vaccination in Pregnant Women

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001159448
Acronym
REVULPOP
Enrollment
50
Registered
2025-10-23
Start date
2025-11-03
Completion date
2026-12-31
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective observational exploratory study investigating the immunological effects of RSV vaccination in pregnant women. All pregnant women will receive a single dose of the Abrysvo RSV vaccine. Detailed exploratory systems biology assays (transcriptomics, epigenetics, lipidomics, metabolomics) and flow cytometry will be performed to investigate the broad immunomodulatory effects of RSV vaccination.

Interventions

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.

Sponsors

Tasmanian Health Service
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026