Study of Maternal Hepatitis C Infection and Influenza Vaccination in Pregnancy

NCT00810875 | Terminated

• 1 other identifier: HCVP-1
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

pregnancy; immunity; cord blood; influenza vaccines; disease transmission, vertical

Outcome Measures

Primary Outcomes (1)

• Detection and characterization of cord blood immune responses against hepatitis C virus and influenza virus vaccine

  single time point (birth)

Secondary Outcomes (2)

• 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

  2 time points (prenatal and postpartum time points)

Study Arms (2)

hepatitis C

pregnant women with hepatitis C virus infection and their infants

controls

pregnant women without hepatitis C infection and their infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both groups will be selected from an outpatient obstetrics clinic.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital, University of California, San Francisco

San Francisco, California, 94110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, peripheral and cord blood mononuclear cells, placental tissue

MeSH Terms

Conditions

Hepatitis C; Influenza, Human

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Study Officials

• Joseph M McCune, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

US (1)