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Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers

NCT03383211 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2021-10-20

No results posted yet for this study

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-directionally between maternal and fetal circulation through placenta. Even in the absence of a direct (vertical) transmission of pathogens to fetuses, certain infections make the neonates more prone to allergies and some adverse events of early vaccinations. We postulate that the basal immune status of neonates born to HIV and LTBI infected mothers is primed by gestational exposure to immunological active molecules, which could results in an altered response to early BCG vaccination. Transcripts expression identified by RNA sequencing are compared between sets of mother-child and their respective umbilical cord blood, and between groups of infected and non-infected pairs.

Conditions

  • HIV Infections
  • Neonatal Infection
  • LTBI - Latent Tuberculosis Infection
  • Immune Tolerance

Interventions

OTHER

RNAseq

Transcriptome profiling of peripheral blood using RNA sequencing technology

Sponsors & Collaborators

  • Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu

    collaborator OTHER

  • Children's National Research Institute

    collaborator OTHER

  • DC-Center for Aids Research (DC-CFAR)

    collaborator UNKNOWN

  • SeqLL, Inc.

    collaborator UNKNOWN

  • George Washington University

    lead OTHER

Principal Investigators

  • Ian Toma, MD, PhD · George Washington University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2020-09-01
Completion
2021-06-30

Countries

  • Moldova

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383211 on ClinicalTrials.gov