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

Hepatitis B Clinical Trial

Official title:

A Fetal Seroepidemiologic Study in Hepatitis B Virus Transmitted Via Male Germ Line

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574521
• Other study ID #: tz2008032
• Status: Completed
• Phase: N/A
• First received: April 8, 2012
• Last updated: April 9, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Taizhou Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
China	Taizhou Hospital of Zhejiang Province	LinHai	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
YiYang Zhu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive rate of HBV in uterus	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	one year	No
Secondary	response rate of postnatal vaccination	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).	half a year after immunization series	No