HIV InfectionsIMMUNEONCT03383211
Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
An observational study of HIV Infections and Neonatal Infection, run by George Washington University at 2 sites in Moldova.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection
- What is being tested?
- RNAseq
- How many people
- 125 participants
- Where
- 2 sitesMoldova
- Study dates
- 16 Jun 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women, 18-45 years old who consented for participation in the study. All women are managed by the local national healthcare system without any interventions from the research team. The collection of samples is performed by the local trained medical personnel, and the samples are processed in a research laboratory.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Moldova2 sites
Clinical Municipal Hospital No. 1
Chisinau
National Center for Mother and Child Health
Chisinau
About this study
Official title: Transcriptomic Profile of the Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
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.
Read the 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 RNA sequencing, the samples are collected in Tempus RNA Blood tubes at 5 time-points (TP): maternal peripheral blood at the time of initial diagnosis with HIV (first OBGYN consultation @ 12-16 weeks of pregnancy - TP1); repeated HIV test in 3rd trimester of pregnancy (34-36 weeks- TP2); umbilical cord blood (after delivery and ligation- TP3); neonates (24 hours after birth and after HBV vaccination, prior to BCG vaccination- TP4); and neonates (7 days after BCG vaccination- TP5).
As an indicator of the inflammatory status, the peripheral blood samples collected at the same TP are stained for serological markers of inflammation, exhaustion, maturation and activation.
An advanced bioinformatics analysis examines the immune-associated transcripts in RNAseq samples to assess the V(D)J recombination of T-cell and B-cell receptors along with immune-associated SNPs.
The main goal of the study is to identify in umbilical cord blood the genomic biomarkers of the neonatal basal immune status for guiding an optimal BCG immunization protocol for such neonates and to avoid potential adverse events after vaccination.
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Being tested
- RNAseq
- Keywords
- RNAseq, Next Generation Sequencing, Transcriptome, Peripheral blood transcripts, Tempus Blood RNA Tubes
- Medical subject headings
- HIV Infections, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNAseqOther
Transcriptome profiling of peripheral blood using RNA sequencing technology
| Study group | Role | What they receive |
|---|---|---|
| HIV+ | Pregnant women diagnosed with HIV infection during pregnancy. No intervention beyond the standard care provided for such cohort. Receives: Other: RNAseq | |
| LTBI | Pregnant women diagnosed with Latent form of TB infection (LTBI). No intervention beyond the standard of care provided for such cohort. Receives: Other: RNAseq | |
| HV+/LTBI | Pregnant women diagnosed with HIV and LTBI co-infection. No intervention beyond the standard of care provided for such cohort. Receives: Other: RNAseq | |
| Healthy Control | Healthy pregnant women without HIV or LTBI. No intervention beyond the standard of care provided for such cohort. Receives: Other: RNAseq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immune-associated transcripts
Identification of transcripts that are differential expressed between groups
Measured: Collection of samples 7-days after BCG vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start16 Jun 2017
- Primary completion1 Sep 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu, Children's National Research Institute, DC-Center for Aids Research (DC-CFAR), SeqLL, Inc.
- Responsible party
- Principal investigator, Ian Toma, MD, PhD, George Washington University
- Investigators
- Ian Toma, MD, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383211
- Sponsor's protocol ID
- GWMDA2017
- Acronym
- IMMUNEO
- Status last verified
- Oct 2021
- First submitted
- 19 Dec 2017
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Genomic data will be submitted to the NCBI SRA archive
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomic Profile of the Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
- ClinicalTrials.gov ID
- NCT03383211
- Acronym / sponsor ID
- IMMUNEO / GWMDA2017
- Conditions
- HIV Infections, Neonatal Infection, LTBI - Latent Tuberculosis Infection, Immune Tolerance
- Keywords
- RNAseq, Next Generation Sequencing, Transcriptome, Peripheral blood transcripts, Tempus Blood RNA Tubes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Universitatea de Stat de Medicina si Farmacie Nicolae Testemiţanu, Children's National Research Institute, DC-Center for Aids Research (DC-CFAR), SeqLL, Inc.
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 RNA sequencing, the samples are collected in Tempus RNA Blood tubes at 5 time-points (TP): maternal peripheral blood at the time of initial diagnosis with HIV (first OBGYN consultation @ 12-16 weeks of pregnancy - TP1); repeated HIV test in 3rd trimester of pregnancy (34-36 weeks- TP2); umbilical cord blood (after delivery and ligation- TP3); neonates (24 hours after birth and after HBV vaccination, prior to BCG vaccination- TP4); and neonates (7 days after BCG vaccination- TP5).
As an indicator of the inflammatory status, the peripheral blood samples collected at the same TP are stained for serological markers of inflammation, exhaustion, maturation and activation.
An advanced bioinformatics analysis examines the immune-associated transcripts in RNAseq samples to assess the V(D)J recombination of T-cell and B-cell receptors along with immune-associated SNPs.
The main goal of the study is to identify in umbilical cord blood the genomic biomarkers of the neonatal basal immune status for guiding an optimal BCG immunization protocol for such neonates and to avoid potential adverse events after vaccination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | Other: RNAseqPregnant women diagnosed with HIV infection during pregnancy. No intervention beyond the standard care provided for such cohort. |
| LTBI | – | Other: RNAseqPregnant women diagnosed with Latent form of TB infection (LTBI). No intervention beyond the standard of care provided for such cohort. |
| HV+/LTBI | – | Other: RNAseqPregnant women diagnosed with HIV and LTBI co-infection. No intervention beyond the standard of care provided for such cohort. |
| Healthy Control | – | Other: RNAseqHealthy pregnant women without HIV or LTBI. No intervention beyond the standard of care provided for such cohort. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women, 18-45 years old who consented for participation in the study. All women are managed by the local national healthcare system without any interventions from the research team. The collection of samples is performed by the local trained medical personnel, and the samples are processed in a research laboratory.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNAseqTranscriptome profiling of peripheral blood using RNA sequencing technology | Other | HIV+, HV+/LTBI, Healthy Control, LTBI |
Primary outcome
Changes in immune-associated transcripts
Time frame: Collection of samples 7-days after BCG vaccination
Identification of transcripts that are differential expressed between groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Yes. Genomic data will be submitted to the NCBI SRA archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Toma, MD, PhD principal investigator
George Washington University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Neonatal Infection, run by George Washington University at 2 sites in Moldova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in immune-associated transcripts (time frame: Collection of samples 7-days after BCG vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.