Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of California, San Francisco.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00810875
First received: December 16, 2008
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Analysis of the Maternal-fetal Interface During Maternal Hepatitis C Virus Infection and Influenza Virus Vaccination

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine [ Time Frame: single time point (birth) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, peripheral and cord blood mononuclear cells, placental tissue


Estimated Enrollment: 140
Study Start Date: April 2009
Estimated Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
hepatitis C
pregnant women with hepatitis C virus infection and their infants
controls
pregnant women without hepatitis C infection and their infants

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Both groups will be selected from an outpatient obstetrics clinic.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810875

Locations
United States, California
San Francisco General Hospital, University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Joseph M McCune, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00810875     History of Changes
Other Study ID Numbers: HCVP-1
Study First Received: December 16, 2008
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
pregnancy
immunity
cord blood
influenza vaccines
disease transmission, vertical

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Influenza, Human
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014