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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; RSV Immunization
• Intervention / Treatment: Drug: RSVpreF

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeffrey MH Wong, MD, FRCSC; Phone Number: 604-875-2212; Email: jeffrey.wong@phsa.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Pregnant women/people aged ≥19 years
2. Confirmed diagnosis of HIV
3. Gestational age between 28 and 34 weeks at enrollment (to allow scheduling of vaccination at 32-36 weeks)
4. Able to provide informed consent

Exclusion Criteria:

1. Contraindications to RSVpreF vaccine per product monograph
2. History of severe allergic reaction to any vaccine component
3. Planned delivery outside of British Columbia
4. Received RSVpreF in current or previous pregnancy
5. Received immunoglobulins (except Rh (D) immuneglobulin) within 1 year of enrollment
6. Unable to complete in-person follow-up for infant at the Oak Tree Clinic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pregnant people with HIV; 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	8-10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile and reactogenicity	Among pregnant women/people with HIV vaccinated with RSVpreF, proportion of individuals with fatigue, headache, and fever will be determined	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.	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	4 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Women's Health Research Institute of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: HIV; RSV; RSVpreF
• Other Study ID Numbers: H26-01191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes