Materno-fetal Transfer of Anti-HCMV-IgGMoChi-HCMVNCT02689700
Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns
An observational study of Materno-fetal Transfer of Anti-HCMV-IgG and Materno-fetal Transfer of Anti-VZV-IgG, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth. Read more about this study
- Who is it for?
- Ages 1 minute to 10 minutesHealthy volunteers can take part
- Conditions the study is for
- Materno-fetal Transfer of Anti-HCMV-IgG, Materno-fetal Transfer of Anti-VZV-IgG
- What is being tested?
- Blood samples
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jul 2018
- 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 1 minute to 10 minutes
- All sexes
- Healthy volunteers accepted
- Child
Study population: Approximately 450 mother-child-pairs seropositive for HCMV and/or VZV
Who may be able to join
- HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.
Who cannot join
- Newborns of underage mothers.
- Newborns whose mother did not sign the written informed consent.
- Pregnant women with a known hereditary or acquired immune deficiency
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinic of the Johann Wolfgang-Goethe Univeristy
Frankfurt am Main, Hesse, 60590
Horst Buxmann, Dr. med., 0049 69 6301 ext. 5247, horst.buxmann@kgu.de
Rolf L Schloesser, Prof Dr med, 0049 69 6301 ext. 5120, rolf.schloesser@kgu.de
About this study
Official title: Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns
The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.
Read the detailed description
For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:
Mother: Venous blood sample taken at birth (+/- three days)
Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.
The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.
- Being tested
- Blood samples
- Keywords
- Human Cytomegalovirus, Varicella Zoster Virus, Materno-fetal antibody transfer, Pregnancy, Gestational age
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
| Study group | Role | What they receive |
|---|---|---|
| HCMV antibody-transfer | Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation Receives: Other: Blood samples | |
| VZV antibody-transfer | Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.
Measurement of HCMV and VZV-antibodies in the fetal and the maternal circulation
Measured: Newborn: immediately after birth; Mother +/- 3 days at birth
Secondary outcomes (1)
Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.
Measurement of neutralizing IgG-HCMV and VZV-antibodies in the fetal and the maternal circulation
Measured: Newborn: immediately after birth; Mother +/- 3 days at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJul 2013
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Materno-fetal Transfer of Anti-HCMV-IgGStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689700
- Sponsor's protocol ID
- 040713 FRA Mat Fet CMV Antib
- Acronym
- MoChi-HCMV
- Status last verified
- Mar 2017
- First submitted
- 19 Feb 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hobbs JR, Davis JA. Serum gamma-G-globulin levels and gestational age in premature babies. Lancet. 1967 Apr 8;1(7493):757-9. doi: 10.1016/s0140-6736(67)91369-4. No abstract available.
PubMed 4164125Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.
PubMed 12850341Mussi-Pinhata MM, Pinto PC, Yamamoto AY, Berencsi K, de Souza CB, Andrea M, Duarte G, Jorge SM. Placental transfer of naturally acquired, maternal cytomegalovirus antibodies in term and preterm neonates. J Med Virol. 2003 Feb;69(2):232-9. doi: 10.1002/jmv.10271.
PubMed 12683413Linder N, Waintraub I, Smetana Z, Barzilai A, Lubin D, Mendelson E, Sirota L. Placental transfer and decay of varicella-zoster virus antibodies in preterm infants. J Pediatr. 2000 Jul;137(1):85-9. doi: 10.1067/mpd.2000.106902.
PubMed 10891827
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns
- ClinicalTrials.gov ID
- NCT02689700
- Acronym / sponsor ID
- MoChi-HCMV / 040713 FRA Mat Fet CMV Antib
- Keywords
- Human Cytomegalovirus, Varicella Zoster Virus, Materno-fetal antibody transfer, Pregnancy, Gestational age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- 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.
The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.
Detailed description
For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:
Mother: Venous blood sample taken at birth (+/- three days)
Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.
The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCMV antibody-transfer | – | Other: Blood samplesMaterno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation |
| VZV antibody-transfer | – | Other: Blood samplesMaterno-fetal VZV antibody-Transfer form 24-41 weeks of gestation |
Who may qualify
- Ages
- 1 minute to 10 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Approximately 450 mother-child-pairs seropositive for HCMV and/or VZV
Key inclusion criteria (1 listed)
- HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.
Key exclusion criteria (3 listed)
- Newborns of underage mothers.
- Newborns whose mother did not sign the written informed consent.
- Pregnant women with a known hereditary or acquired immune deficiency
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 |
|---|---|---|
| Blood samplesTaking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother. | Other | HCMV antibody-transfer, VZV antibody-transfer |
Primary outcome
To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.
Time frame: Newborn: immediately after birth; Mother +/- 3 days at birth
Measurement of HCMV and VZV-antibodies in the fetal and the maternal circulation
1 secondary outcome
Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.
Time frame: Newborn: immediately after birth; Mother +/- 3 days at birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Results publication: PubMed 4164125Hobbs JR, Davis JA. Serum gamma-G-globulin levels and gestational age in premature babies. Lancet. 1967 Apr 8;1(7493):757-9. doi: 10.1016/s0140-6736(67)91369-4. No abstract available.
- Results publication: PubMed 12850341Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.
- Results publication: PubMed 12683413Mussi-Pinhata MM, Pinto PC, Yamamoto AY, Berencsi K, de Souza CB, Andrea M, Duarte G, Jorge SM. Placental transfer of naturally acquired, maternal cytomegalovirus antibodies in term and preterm neonates. J Med Virol. 2003 Feb;69(2):232-9. doi: 10.1002/jmv.10271.
- Results publication: PubMed 10891827Linder N, Waintraub I, Smetana Z, Barzilai A, Lubin D, Mendelson E, Sirota L. Placental transfer and decay of varicella-zoster virus antibodies in preterm infants. J Pediatr. 2000 Jul;137(1):85-9. doi: 10.1067/mpd.2000.106902.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Materno-fetal Transfer of Anti-HCMV-IgG and Materno-fetal Transfer of Anti-VZV-IgG, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Horst Buxmann, PI (+49 69 6301 ext. 5524, horst.buxmann@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth. (time frame: Newborn: immediately after birth; Mother +/- 3 days at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689700, which also lists 4 linked publications.
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 7 Mar 2017.