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

NCT07693166 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: H26-01191
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV; RSV Immunization

Keywords

HIV; RSVpreF; RSV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Safety profile and reactogenicity

  8-10 weeks

• Pregnancy Factors

  8-10 weeks

• Acceptability

  4 weeks

Study Arms (1)

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

Drug: RSVpreF

Interventions

RSVpreF DRUG

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.

Pregnant people with HIV

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator

Central Study Contacts

Jeffrey MH Wong, MD, FRCSC

CONTACT

604-875-2212; jeffrey.wong@phsa.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 9, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share