Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF (SHIELD-RSV)
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
- 否
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
Jeffrey Wong
Clinical Assistant Professor
University of British Columbia
