RSV ImmunizationPhase 4SHIELD-RSVNCT07693166
Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF
A Phase 4 study testing RSVpreF in people with RSV Immunization and HIV, run by University of British Columbia.
Trial summary
Respiratory syncytial virus (RSV) is the leading cause of hospitalization in young infants in Canada. While most babies recover, RSV can cause severe breathing problems and place major stress on families and the health system. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- RSV Immunization, HIV
- What is being tested?
- RSVpreF
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women/people aged ≥19 years
- Confirmed diagnosis of HIV
- Gestational age between 28 and 34 weeks at enrollment (to allow scheduling of vaccination at 32-36 weeks)
- Able to provide informed consent
Who cannot join
- Contraindications to RSVpreF vaccine per product monograph
- History of severe allergic reaction to any vaccine component
- Planned delivery outside of British Columbia
- Received RSVpreF in current or previous pregnancy
- Received immunoglobulins (except Rh (D) immuneglobulin) within 1 year of enrollment
- Unable to complete in-person follow-up for infant at the Oak Tree Clinic
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF (SHIELD-RSV)
Respiratory syncytial virus (RSV) is the leading cause of hospitalization in young infants in Canada. While most babies recover, RSV can cause severe breathing problems and place major stress on families and the health system. Infants born to pregnant women and people with HIV, even if they do not acquire the virus, face higher risks of RSV illness. This is partly because HIV increases the chance of preterm birth and can reduce the amount of protective antibodies passed to the baby during pregnancy.
Two new tools now exist to prevent RSV. One is a vaccine given in late pregnancy (RSVpreF), which boosts antibodies that cross the placenta and protect the baby at birth. The other is a long-lasting antibody (nirsevimab) given directly to infants after delivery. Both work well in the general population, but pregnant people living with HIV were excluded from the original studies. Health care providers therefore do not know if perinatal vaccination provides enough protection for these babies.
This study will follow 20 pregnant women/people with HIV at BC Women's Hospital who receive the RSVpreF vaccine. Antibody levels will be measured before and after vaccination from the pregnant recipient, and in infant blood sample, to see how well protection is transferred to infants. We will also assess vaccine safety, birth outcomes, and parental views on RSV immunization. Findings will guide Canadian policies to ensure that all infants, including those exposed to HIV, have equitable access to RSV protection.
- Conditions
- RSV Immunization, HIV
- Being tested
- RSVpreF
- Keywords
- HIV, RSVpreF, RSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVpreFDrug
Participants will receive a single dose of the RSVpreF vaccine (Abrysvo®) intramuscularly between 32+0 and 36+6 weeks of gestation, consistent with Health Canada approval.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant people with HIV | Experimental | We plan to recruit 20 pregnant women/people with HIV receiving antenatal care in British Columbia. Recruitment site will be the Oak Tree Clinic at BC Women's Hospital, which is the provincial referral centre for all pregnant women/people with HIV in British Columbia.
Inclusion criteria:
* Pregnant women/people aged ≥18 years
* Confirmed HIV infection
* Gestational age between 28 and 34 weeks at enrollment (to allow scheduling of vaccination at 32-36 weeks)
* Able to provide informed consent in English Receives: Drug: RSVpreF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
To measure the RSV neutralizing antibody geometric mean titer and geometric mean ratio in twenty pregnant women/people with HIV at pre-vaccination (32-36 weeks) and post-vaccination (4 weeks post-vaccination) from RSVpreF
Measured: Within 10 weeks
Transplacental Antibody
To measure the RSV neutralizing antibody geometric mean titer and geometric mean ratio through infant dried blood spots after birth among twenty infants born to pregnant people with HIV immunized with RSVpreF
Measured: 8-10 weeks
Secondary outcomes (3)
Safety profile and reactogenicity
Among pregnant women/people with HIV vaccinated with RSVpreF, proportion of individuals with fatigue, headache, and fever will be determined
Measured: 8-10 weeks
Pregnancy Factors
Among pregnant women/people with HIV vaccinated with RSVpreF, gestational age at delivery and rate of adverse birth outcomes (e.g., rate of preterm birth, low birth weight) will be determined as percentage of cohort.
Measured: 8-10 weeks
Acceptability
To understand the acceptability of RSV immunization strategies among pregnant women/people with HIV, presented as descriptive statistics based on proportion who would accept repeat vaccination and/or recommend to others
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV ImmunizationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Responsible party
- Principal investigator, Jeffrey Wong, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693166
- Sponsor's protocol ID
- H26-01191
- Acronym
- SHIELD-RSV
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No