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临床试验/NCT07693166
NCT07693166尚未招募4 期

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

University of British Columbia0 个研究点目标入组 20 人开始时间: 2026年9月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
20
主要终点
Immunogenicity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Immunogenicity

时间窗: Within 10 weeks

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

Transplacental Antibody

时间窗: 8-10 weeks

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

次要结局

  • Safety profile and reactogenicity(8-10 weeks)
  • Pregnancy Factors(8-10 weeks)
  • Acceptability(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey Wong

Clinical Assistant Professor

University of British Columbia

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