Seroepidemiologic Study of Spermatozoal Transmission of Hepatitis B Virus (HBV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
YiYang Zhu, Taizhou Hospital
ClinicalTrials.gov Identifier:
NCT01574521
First received: April 8, 2012
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

Animal experiments demonstrated that father might transmit HBV vertically via male germ line, however, whether it is really existed in human remains to be determined. Since HBV is a blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their fetuses carried the virus from fathers. If women had been vaccinated for HBV before conception, what would happen to a maternal immune system if her fetus carried HBV from spermatozoa? However, the literature on transmission of HBV by spermatozoa in vivo is rare, the viral replicating status and fetal immune response in uterus are unknown. The aim of study was to detect father-to-fetus transmission of hepatitis B virus (HBV) in uterus.


Condition
Hepatitis B

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Fetal Seroepidemiologic Study in Hepatitis B Virus Transmitted Via Male Germ Line

Resource links provided by NLM:


Further study details as provided by Taizhou Hospital:

Primary Outcome Measures:
  • positive rate of HBV in uterus [ Time Frame: one year ] [ Designated as safety issue: No ]
    HBV infection confirmed by serological makers(HBsAg, HBeAg, anti-HBs, anti-HBe anti-HBc)and HBVDNA. Samples were assessed by enzyme immunoassays and FQ-PCR


Secondary Outcome Measures:
  • response rate of postnatal vaccination [ Time Frame: half a year after immunization series ] [ Designated as safety issue: No ]
    neonates received three doses of recombinant vaccines were given on a 0-, 1-, and 6-month schedule, and other 100 IU of HBIG was administrated within 24 hours after birth. Post-vaccination testing for efficacy evaluation was performed at one-year old (half a year after immunization series).


Biospecimen Retention:   Samples With DNA

whole blood, serum,amniotic fluid


Enrollment: 407
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Only father carrier
fetuses whose fathers were HBV carriers whereas mothers negatively.
only mother carrier
fetuses whose mothers were HBV carriers whereas fathers negatively.
both parents carriers
fetuses whose both parents were HBV carriers

Detailed Description:

Transmission of hepatitis B virus (HBV) from mother-to-infant is the predominant route in most high prevalence areas such as China. However, father-to-child transmission also plays another important role in the prevalence of hepatitis B. Children infected with HBV from their carrier fathers would be horizontally by postnatal intimate contact or vertically via male germ line. The latter is considered an intrauterine infection, however, whether it is really existed in human remains to be determined.

In past decades, several experiments reported there presences of integrated HBV DNA in human spermatozoal chromosomes. Studies on embryos hybridized with mammalian ova and human spermatozoa were also confirmed that sperm-integrated HBV DNA can replicate and express the HBV protein in two-cell' hybrid embryos. All above findings demonstrated that father might transmit HBV to fetus by spermatozoa in theory.

Since HBV is a blood-borne virus, the unvaccinated pregnant women would be at risk for HBV exposure if their fetuses carried the virus from fathers. On other hand, maternal antibodies can pass through the placenta and enter the fetal circulation freely. If women had been vaccinated for HBV before conception, thus some attractive questions are raised that what would happen to a maternal immune system if her fetus carried HBV from spermatozoa? Would the fetus be passive immunized by hepatitis B immunoglobulin leaked from maternal circulation? However, the literature on transmission of HBV by spermatozoa in vivo is rare, the viral replicating status and fetal immune response in uterus are unknown. Only one study had detected HBV DNA and serological makers on eight aborted fetuses suspected with HBV transmission via spermatozoa, but it is a small sample study and the maternal serological status is uncertain.

Specimens applied for evaluating intrauterine infection include amniotic fluids, placental tissue and neonatal peripheral blood. Because postnatal sample is inevitably to be contaminated by maternal blood during delivery, it would be useless to determine the time when the infection was occurred (before or during the partum). A better alternative is detecting fetal infection before the partum by prenatal diagnostic technique. Comparing to the postnatal specimens, intrauterine specimens obtained from amniocentesis or cordocentesis can minimize the contamination of maternal blood. It is also a safety technique and the risk of nosocomial infection caused by invasive procedures is very low. The aim of this study was to investigate the fetal hepatitis B seroepidemiology by prenatal diagnostic technique and to find the evidence of HBV vertical transmission via spermatozoa.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The research consisted of the pregnant women who visited for prenatal diagnosis during the January 2008 and June 2010.

Criteria

Inclusion Criteria:

  • one or both of pregnant Woman and her husband were HBV carriers
  • indicated for amniocentesis or cordocentesis

Exclusion Criteria:

  • indicated for chorionic villous sampling
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574521

Locations
China, Zhejiang
Taizhou Hospital of Zhejiang Province
LinHai, Zhejiang, China, 317000
Sponsors and Collaborators
YiYang Zhu
Investigators
Study Director: Yi-Yang Zhu, MD Taizhou Hospital of Zhejiang Province
  More Information

No publications provided

Responsible Party: YiYang Zhu, Center for Prenatal Diagnosis, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT01574521     History of Changes
Other Study ID Numbers: tz2008032
Study First Received: April 8, 2012
Last Updated: April 9, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014