Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns (MoChi-HCMV)

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.

Study Overview

• Status: Unknown
• Conditions: Materno-fetal Transfer of Anti-HCMV-IgG; Materno-fetal Transfer of Anti-VZV-IgG
• Intervention / Treatment: Other: Blood samples

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 Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

Study Locations

• Germany
  • Hesse
    • Frankfurt/Main, Hesse, Germany, 60590
      • Recruiting
      • Clinic of the Johann Wolfgang-Goethe Univeristy
      • Contact: Horst Buxmann, Dr. med.; Phone Number: 5247 0049 69 6301; Email: horst.buxmann@kgu.de
      • Contact: Rolf L Schloesser, Prof Dr med; Phone Number: 5120 0049 69 6301; Email: rolf.schloesser@kgu.de
      • Principal Investigator: Horst Buxmann, Dr. med.
      • Sub-Investigator: Hannah Hürter, Dr. med.
      • Sub-Investigator: Clara A Lüdeke, Cand. med.
      • Sub-Investigator: Frank Louwen, Prof Dr med
      • Sub-Investigator: Rolf L Schloesser, Prof Dr med
      • Sub-Investigator: Holger F Rabenau, Prof Dr rer nat
      • Sub-Investigator: Hanns Ackermann, Dr rer med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 10 minutes (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 450 mother-child-pairs seropositive for HCMV and/or VZV

Description

Inclusion Criteria:

• HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.

Exclusion Criteria:

• Newborns of underage mothers.
• Newborns whose mother did not sign the written informed consent.
• Pregnant women with a known hereditary or acquired immune deficiency

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HCMV antibody-transfer; Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation	Other: Blood samples; Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
VZV antibody-transfer; Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation	Other: Blood samples; Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Newborn: immediately after birth; Mother +/- 3 days at birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Newborn: immediately after birth; Mother +/- 3 days at birth

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital

Publications and helpful links

General 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.
• Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.
• Mussi-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.
• Linder 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: February 19, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 4, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; Gestational age; Varicella Zoster Virus; Human Cytomegalovirus; Materno-fetal antibody transfer
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Herpesviridae Infections; Varicella Zoster Virus Infection; Premature Birth; Herpes Zoster
• Other Study ID Numbers: 040713 FRA Mat Fet CMV Antib

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO