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NOT YET RECRUITING
NCT07693166
PHASE4

Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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. 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.

Official title: Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF (SHIELD-RSV)

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-01

Completion Date

2028-03-01

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

RSVpreF

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.