Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500747
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2007-07-12
Brief Title:
Chiron Corp HCV E1E2 Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Randomized Observer-Blinded Placebo-Controlled Study to Evaluate the Safety Tolerability and Immunogenicity of Chiron Corporations HCV E1E2MF59 Vaccine Administered to Healthy HCV-Negative Adults
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to evaluate the safety tolerability and effectiveness of a vaccine the HCV E1E2MF59 vaccine against hepatitis C HCV The vaccine will be given to 60 healthy adult volunteers aged 18-45 years and the study will compare the immune system the bodys protective response response to the HCV E1E2 vaccine given at different dosage levels 4 micrograms 20 micrograms or 100 micrograms in MF59 adjuvant substance that can improve vaccine effectiveness The volunteers will be assigned randomly by chance to 1 of 4 different groups Volunteers in each group will receive a shot of the vaccine or a placebo shot with no medication Participants will be involved in study related procedures for up to 71 weeks which includes blood samples recording symptoms on a diary card and 4 vaccine or placebo injections
Detailed Description:
Hepatitis C virus HCV has emerged as a significant public health concern throughout the world Its estimated prevalence in the US is 15 percent or 27 million people with chronic infection As many as 170 million people may have chronic HCV infection worldwide The Centers for Disease control currently estimates that 40000 HCV infections occur yearly in the US with most current infection acquired through illegal injection drug use It is estimated that 70 percent of those infected will develop chronic liver disease The purpose of this study is to conduct a Phase I vaccine trial with a novel vaccine HCV E1E2MF59 The study objectives are to evaluate the safety tolerability and immunogenicity of HCV E1E2MF59 vaccine administered to healthy adult subjects and to compare the immune response to HCV E1E2 vaccine given at 4 20 or 100 mcg in MF59 adjuvant Sixty healthy adults aged 18-45 will be randomized to receive one of 3 different doses of vaccine or placebo Each subject will receive vaccine at 0 4 24 and 48 weeks Study procedures will include blood sample collections and questions regarding risk factors for acquiring HCV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11806 | None | None | None |