Prevention of Human Cytomegalovirus (HCMV) Mother-to-fetus Transmission by Administration of Virus-specific Hyperimmune Globulin to Pregnant Women With Primary HCMV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 11
- 主要终点
- Evidence of congenital HCMV infection in the fetus/newborn
研究概览
简要总结
The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.
详细描述
HCMV is the leading infectious cause of mental retardation and deafness in infants with congenital HCMV infection. Primary HCMV infections during pregnancy carry the highest risk of fetal infection and disease. No intervention of proven efficacy is available in case of primary HCMV infection in pregnancy. However, a study published in 2005 (Nigro et al., NEJM 353:1350-62, 2005) reported that in pregnant women with primary HCMV infection treated with HCMV-specific hyperimmune globulin (Cytotect®, Biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. Unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed.
In the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary HCMV infection at 4-26 weeks of gestation will be randomized to receive Cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection.
Primary efficacy parameter will be the number of HCMV-infected newborns or fetuses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women (in vitro fertilization permitted)
- •>= 18 years of age
- •primary HCMV infection at 5-26 weeks' gestation
- •<= 6 weeks from presumed onset of infection
- •gestational age between 5-32 weeks' gestation
- •written informed consent
排除标准
- •multiple pregnancy
- •history of HIV or HBV or HCV infection
- •known immunodeficiency or immunosuppression
- •congenital or acquired autoimmune disease
- •known intolerance to protein of human origin
- •known intolerance to immune globulin
- •history of adverse effects to vaccination
- •hypersensitivity to human immune globulin (pathological IgG or IgA deficiences)
- •renal failure
- •serious organic or psychiatric disease
- •lack of motivation to participate in the study
- •women unable to satisfy study requirements
- •women not willing or unable to provide written informed consent
- •women not willing to give consent to transmission of anonymised data
研究组 & 干预措施
Cytotect
干预措施: HCMV-specific hyperimmune globulin (Cytotect®) (Drug)
placebo
干预措施: Isotonic solution of sodium chloride (placebo) (Drug)
结局指标
主要结局
Evidence of congenital HCMV infection in the fetus/newborn
时间窗: At amniocentesis and/or within one week after birth
次要结局
- HCMV-specific immune response (humoral and cell-mediated)(36-48 months)
- Virological and histological findings in placentas(36-48 months)
- Clinical outcome of newborns with congenital HCMV infection(within 2 weeks after birth)
- Safety of Cytotect in the mother and newborn(within 24 hours after delivery)
研究者
Maria Grazia Revello
researcher
Fondazione IRCCS Policlinico San Matteo di Pavia