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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jeffrey MH Wong, MD, FRCSC
- Número de teléfono: 604-875-2212
- Correo electrónico: jeffrey.wong@phsa.ca
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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:
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immunogenicity
Periodo de tiempo: Within 10 weeks
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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
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Within 10 weeks
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Transplacental Antibody
Periodo de tiempo: 8-10 weeks
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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
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8-10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety profile and reactogenicity
Periodo de tiempo: 8-10 weeks
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Among pregnant women/people with HIV vaccinated with RSVpreF, proportion of individuals with fatigue, headache, and fever will be determined
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8-10 weeks
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Pregnancy Factors
Periodo de tiempo: 8-10 weeks
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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.
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8-10 weeks
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Acceptability
Periodo de tiempo: 4 weeks
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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
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre VIH
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Icahn School of Medicine at Mount SinaiClearPoint NeuroReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
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Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
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China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre RSVpreF
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PfizerTerminado
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PfizerTerminadoVirus Respiratorio Sincitial (RSV)Estados Unidos
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PfizerReclutamientoVirus Respiratorio Sincitial (RSV)Japón
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PfizerTerminadoVIRUS SINCITIAL RESPIRATORIO (RSV)Estados Unidos
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PfizerTerminadoInfección del tracto respiratorioEstados Unidos, Países Bajos, España, Corea, república de, Dinamarca, Taiwán, Australia, México, Canadá, Japón, Finlandia, Argentina, Brasil, Chile, Gambia, Nueva Zelanda, Filipinas, Sudáfrica
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HvivoPfizerTerminadoInfecciones por virus respiratorio sincitialReino Unido
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PfizerTerminadoVIRUS SINCITIAL RESPIRATORIO (RSV)Estados Unidos
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PfizerTerminado
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PfizerThe Kids Research Institute Australia on behalf of the Centre for Child Health...Activo, no reclutandoEnfermedades de las vías respiratorias | Virus Respiratorio Sincitial (RSV) | Virus sincitial respiratorio | Enfermedad del tracto respiratorio inferior | Enfermedad respiratoria aguda (ARI)Australia