NCT07693166Not yet recruitingPhase 4
Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF
Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF (SHIELD-RSV)
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of British Columbia
- Diseases
- HIV
- NCT number
- NCT07693166
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to RSVpreF vaccine per product monograph
- Received RSVpreF in current or previous pregnancy
- Received immunoglobulins (except Rh (D) immuneglobulin) within 1 year of enrollment
Other illness
- History of severe allergic reaction to any vaccine component
Other
- Planned delivery outside of British Columbia
- Unable to complete in-person follow-up for infant at the Oak Tree Clinic
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.