Clinical trial NCT00810875: Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy
Official title: Analysis of the Maternal-fetal Interface During Maternal Hepatitis C Virus Infection and Influenza Virus Vaccination
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Keywords: pregnancy
immunity
cord blood
influenza vaccines
disease transmission, vertical
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both groups will be selected from an outpatient obstetrics clinic.

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.

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

Primary outcomes:
measure: Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine
timeFrame: single time point (birth)
Secondary outcomes:
measure: Characterization of immune responses in infants against hepatitis C virus and influenza virus vaccine
timeFrame: 2 time points (9-15 months and 24 months)
measure: Detection and characterization of immune responses against hepatitis C virus and influenza virus vaccine in mothers
timeFrame: 2 time points (prenatal and postpartum time points)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital, University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joseph M McCune, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: