Hepatitis BNCT01574521
Seroepidemiologic Study of Spermatozoal Transmission of Hepatitis B Virus (HBV)
An observational study of Hepatitis B, run by YiYang Zhu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Hepatitis B
- How many people
- 407 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2011
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The research consisted of the pregnant women who visited for prenatal diagnosis during the January 2008 and June 2010.
Who may be able to join
- one or both of pregnant Woman and her husband were HBV carriers
- indicated for amniocentesis or cordocentesis
Who cannot join
- indicated for chorionic villous sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Fetal Seroepidemiologic Study in Hepatitis B Virus Transmitted Via Male Germ Line
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.
Read the 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.
- Conditions
- Hepatitis B
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
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).
Measured: half a year after immunization series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- YiYang Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiYang Zhu, Taizhou Hospital
- Investigators
- Yi-Yang Zhu, MD, Study director, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574521
- Sponsor's protocol ID
- tz2008032
- Status last verified
- Apr 2012
- First submitted
- 8 Apr 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fetal Seroepidemiologic Study in Hepatitis B Virus Transmitted Via Male Germ Line
- ClinicalTrials.gov ID
- NCT01574521
- Acronym / sponsor ID
- tz2008032
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- YiYang ZhuUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Apr 2012 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The research consisted of the pregnant women who visited for prenatal diagnosis during the January 2008 and June 2010.
Key inclusion criteria (2 listed)
- one or both of pregnant Woman and her husband were HBV carriers
- indicated for amniocentesis or cordocentesis
Key exclusion criteria (1 listed)
- indicated for chorionic villous sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
positive rate of HBV in uterus
Time frame: one year
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
1 secondary outcome
response rate of postnatal vaccination
Time frame: half a year after immunization series
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
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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.
Yi-Yang Zhu, MD study director
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
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 Hepatitis B, run by YiYang Zhu at 1 site in China.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 2012. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive rate of HBV in uterus (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2012.