Evolution of HCMV Non-primary Infection and Host Immune Response in HCMV-seropositive Mothers of Children Attending Day-care Centers: an Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- HCMV non-primary infection (reinfection or reactivation).
研究概览
简要总结
The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.
Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).
To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers.
详细描述
Eligible women will be identified and enrolled during pregnancy or at delivery. Consenting mothers will be tested for HCMV DNA in saliva, urine and vaginal swab at delivery and/or at the first scheduled post-partum visit (2-4 months after delivery). In addition, mothers and children will be tested for presence of HCMV DNA in milk and saliva samples, respectively.
A mother-child pair is considered HCMV-DNA positive and, therefore, suitable for continuing the study (i.e. the 12 months follow up after admission of the child to day care center) whenever viral DNA is detected in clinical samples of either the mother or the child or both. In fact, when viral DNA is undetectable in the mother but is present in the saliva of a 2-4 month old infant it can be reasonably assumed that the strain is of maternal origin.
The study does not require any modification in the normal mother-child relationship and participating mothers will be encouraged to behave normally. However, mothers will be asked to fill in a short questionnaire about basic behaviours in daily child care (i.e. frequency of hand washing, kissing of the infant, sharing of food...).
The following clinical samples will be collected from mothers and infants at indicated times (T):
T0. Delivery:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult (≥18 years of age) HCMV IgG-positive, breast feeding* woman.
- •Willingness to enroll the infant in a public or private day care facility with at least 5 attendees at ≤ 12 months of age.
- •Willingness to participate in the study.
- •In case of foreign origin, language skills sufficient to understand information material and give informed consent.
- •Written informed consent. * Breast feeding not required in case of availability of HCMV DNA-positive samples from the mother and/or fetus and/or newborn.
排除标准
- •Congenital or acquired immunodeficiency
- •Immunosuppressive therapy
结局指标
主要结局
HCMV non-primary infection (reinfection or reactivation).
时间窗: T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.
HCMV non-primary infections will be calculated as the frequency of women with the presence of HCMV DNA in at least one of the body compartments examined (blood, saliva, urine, genital tract) at any time point. Reinfections will be considered non-primary infections in which the HCMV strain detected is different from the strain detected at baseline.
次要结局
- HCMV-specific humoral and cell-mediated immune response during non-primary infection.(T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.)
- Maternal behaviours and occurrence of non-primary infection(T3-T6: 3-6-9-12 months after admission of the infant to the day-care center.)
研究者
Daniele Lilleri
Principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia