Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

NCT ID: NCT00810875

Last Updated: 2014-08-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-08-31

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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

hepatitis C

pregnant women with hepatitis C virus infection and their infants

No interventions assigned to this group

controls

pregnant women without hepatitis C infection and their infants

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph M McCune, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital, University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

HCVP-1

Identifier Type: -

Identifier Source: org_study_id