Status:
COMPLETED
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu
Children's National Research Institute
Conditions:
HIV Infections
Neonatal Infection
Eligibility:
FEMALE
18-45 years
Brief Summary
Maternal infections affect the basal immune status of neonates. One of the possible mechanism is the fetomaternal microchimerism, in which some cells and active substances are exchanged bi-directional...
Detailed Description
The study is comparing the transcriptomic profiles of maternal peripheral blood with those of the corresponding umbilical cord blood and neonatal peripheral blood pre- and post-BCG vaccination. For R...
Eligibility Criteria
Inclusion
- Pregnant women, 18-45 years old, capable of reading and understanding the informed consent and the purpose of the study The newborns of the enrolled pregnant women. Women of reproductive age with or without HIV and LTBI infections
Exclusion
- Pregnant women younger than 18 years or older than 45 years of age Pregnant women and infants with known genetic abnormalities, including primary immunodeficiencies; or receiving immunosuppressive therapy; Infants infected in utero, perinatally, or neonatally with hepatitis B virus, Treponema pallidum (syphilis), Toxoplasma gondii, rubella virus, cytomegalovirus, or herpes simplex virus.
- Pregnant women with known history of alcohol or drug abuse, cancer diagnosis and treatment with chemotherapeutic agents, radiation.
- Pregnant women with history of organ transplantation.
Key Trial Info
Start Date :
June 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03383211
Start Date
June 16 2017
End Date
June 30 2021
Last Update
October 20 2021
Active Locations (2)
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1
Clinical Municipal Hospital No. 1
Chisinau, Moldova
2
National Center for Mother and Child Health
Chisinau, Moldova