Study of Maternal Hepatitis C Infection and Influenza Vac... | NCT00810875

Studies
Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

NCT00810875

Sponsor

University of California, San Francisco

Status

Terminated

Last Update Posted

Aug 25, 2014Estimated

Enrollment

6Actual

Phase

Not provided

Conditions

Hepatitis C

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to lack of enrollment

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2014

Last Update Posted Date

Aug 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hepatitis C		pregnant women with hepatitis C virus infection and their infants
controls		pregnant women without hepatitis C infection and their infants

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine		single time point (birth)

Secondary Outcomes

Measure	Description	Time Frame
Characterization of immune responses in infants against hepatitis C virus and influenza virus vaccine		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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

HIV infection
hepatitis B infection
plan to use cord blood for another purpose

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Both groups will be selected from an outpatient obstetrics clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph M McCune, MD, PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital, University of California, San Francisco		San Francisco	California	94110	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D007251	Influenza, Human

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

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Browse Branches

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