Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

Hepatitis C Clinical Trial

Official title:

Analysis of the Maternal-fetal Interface During Maternal Hepatitis C Virus Infection and Influenza Virus Vaccination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00810875
• Other study ID #: HCVP-1
• Status: Terminated
• Phase: N/A
• First received: December 16, 2008
• Last updated: August 21, 2014
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
United States	San Francisco General Hospital, University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine		single time point (birth)	No
Secondary	Characterization of immune responses in infants against hepatitis C virus and influenza virus vaccine		2 time points (9-15 months and 24 months)	No
Secondary	Detection and characterization of immune responses against hepatitis C virus and influenza virus vaccine in mothers		2 time points (prenatal and postpartum time points)	No