Hepatitis CNCT00810875
Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy
An observational study of Hepatitis C, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both groups will be selected from an outpatient obstetrics clinic.
Who may be able to join
- pregnant women 18 years of age or older
- infants born to these women from this pregnancy
- hepatitis C virus antibody and RNA positive (for study group)
- hepatitis C virus antibody and RNA negative (for control group)
Who cannot join
- HIV infection
- hepatitis B infection
- plan to use cord blood for another purpose
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital, University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Analysis of the Maternal-fetal Interface During Maternal Hepatitis C Virus Infection and Influenza Virus Vaccination
The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus.
Read the detailed description
The rate of mother-to-child transmission of hepatitis C virus (HCV) is only 5%, even though the level of fetal exposure to the virus during pregnancy is probably much higher. How can the fetus avoid infection in so many cases? We believe the fetal immune system is not immature as has previously been thought, but instead plays an active role in protecting the fetus from infection. In this study, we aim to better understand the immune response of the fetus against maternal HCV infection. In addition, since the fetus has been shown in some cases to make an immune response against vaccines given to the mother during pregnancy, we also aim to study the fetal immune response against maternal influenza virus vaccination. We plan to study 50 HCV-positive pregnant women and their infants (study group) and compare them to 20 HCV-negative pregnant women and their infants (control group). We estimate that approximately 30 women in the study group will have received the influenza virus vaccine. We will analyze 3 important components of mother-to-child transmission: (1) the maternal immune response against HCV and influenza virus vaccine during and after pregnancy; (2) the baby's immune response to these agents at birth, 9-15 months, and 24 months; and (3) the placenta, for the presence of HCV particles or influenza virus vaccine components. The results of this study may have implications for the prevention of mother-to-child transmission of HCV and other infections, as well as for the development of novel vaccination strategies.
- Conditions
- Hepatitis C
- Keywords
- pregnancy, immunity, cord blood, influenza vaccines, disease transmission, vertical
- Medical subject headings
- Hepatitis C, Influenza, Human
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 |
|---|---|---|
| hepatitis C | pregnant women with hepatitis C virus infection and their infants | |
| controls | pregnant women without hepatitis C infection and their infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine
Measured: single time point (birth)
Secondary outcomes (2)
Characterization of immune responses in infants against hepatitis C virus and influenza virus vaccine
Measured: 2 time points (9-15 months and 24 months)
Detection and characterization of immune responses against hepatitis C virus and influenza virus vaccine in mothers
Measured: 2 time points (prenatal and postpartum time points)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Terminated due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph M McCune, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810875
- Sponsor's protocol ID
- HCVP-1
- Status last verified
- Aug 2014
- First submitted
- 16 Dec 2008
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Maternal-fetal Interface During Maternal Hepatitis C Virus Infection and Influenza Virus Vaccination
- ClinicalTrials.gov ID
- NCT00810875
- Acronym / sponsor ID
- HCVP-1
- Conditions
- Hepatitis C
- Keywords
- pregnancy, immunity, cord blood, influenza vaccines, disease transmission, vertical
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Dec 2008 (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.
The purpose of this study is to determine if hepatitis C virus and influenza virus vaccine components can cross the placenta and stimulate an immune response in the fetus.
Detailed description
The rate of mother-to-child transmission of hepatitis C virus (HCV) is only 5%, even though the level of fetal exposure to the virus during pregnancy is probably much higher. How can the fetus avoid infection in so many cases? We believe the fetal immune system is not immature as has previously been thought, but instead plays an active role in protecting the fetus from infection. In this study, we aim to better understand the immune response of the fetus against maternal HCV infection. In addition, since the fetus has been shown in some cases to make an immune response against vaccines given to the mother during pregnancy, we also aim to study the fetal immune response against maternal influenza virus vaccination. We plan to study 50 HCV-positive pregnant women and their infants (study group) and compare them to 20 HCV-negative pregnant women and their infants (control group). We estimate that approximately 30 women in the study group will have received the influenza virus vaccine. We will analyze 3 important components of mother-to-child transmission: (1) the maternal immune response against HCV and influenza virus vaccine during and after pregnancy; (2) the baby's immune response to these agents at birth, 9-15 months, and 24 months; and (3) the placenta, for the presence of HCV particles or influenza virus vaccine components. The results of this study may have implications for the prevention of mother-to-child transmission of HCV and other infections, as well as for the development of novel vaccination strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatitis C | – | –pregnant women with hepatitis C virus infection and their infants |
| controls | – | –pregnant women without hepatitis C infection and their infants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both groups will be selected from an outpatient obstetrics clinic.
Key inclusion criteria (4 listed)
- pregnant women 18 years of age or older
- infants born to these women from this pregnancy
- hepatitis C virus antibody and RNA positive (for study group)
- hepatitis C virus antibody and RNA negative (for control group)
Key exclusion criteria (3 listed)
- HIV infection
- hepatitis B infection
- plan to use cord blood for another purpose
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
Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine
Time frame: single time point (birth)
2 secondary outcomes
Characterization of immune responses in infants against hepatitis C virus and influenza virus vaccine
Time frame: 2 time points (9-15 months and 24 months)
Detection and characterization of immune responses against hepatitis C virus and influenza virus vaccine in mothers
Time frame: 2 time points (prenatal and postpartum time points)
Results and safety
The study was stopped early (reason given: Terminated due to lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
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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.
Joseph M McCune, MD, PhD principal investigator
University of California, San Francisco
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 C, run by University of California, San Francisco at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 25 Aug 2014. 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 United States. 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 was stopped early (reason given: Terminated due to lack of enrollment). Results are not available in the source record.
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?
Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine (time frame: single time point (birth)). 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 25 Aug 2014.