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

Materno-fetal Transfer of Anti-HCMV-IgG Clinical Trial

— MoChi-HCMV  

Official title:

Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02689700
• Other study ID #: 040713 FRA Mat Fet CMV Antib
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2016
• Last updated: March 4, 2017
• Start date: July 2013
• Est. completion date: July 2018

Study information

• Verified date: March 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Horst Buxmann, PI
• Phone: +49 69 6301
• Email: horst.buxmann[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster
• Materno-fetal Transfer of Anti-HCMV-IgG
• Materno-fetal Transfer of Anti-VZV-IgG

Intervention

Other:
• Blood samples
Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.

Locations

Country	Name	City	State
Germany	Clinic of the Johann Wolfgang-Goethe Univeristy	Frankfurt/Main	Hesse

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Hobbs JR, Davis JA. Serum gamma-G-globulin levels and gestational age in premature babies. Lancet. 1967 Apr 8;1(7493):757-9. — View Citation

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. — View Citation

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. — View Citation

Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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