Viewing Study NCT00100633



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00100633
Status: COMPLETED
Last Update Posted: 2008-10-01
First Post: 2005-01-04

Brief Title: Safety of and Immune Response to a Hepatitis B Virus Vaccine Given With a Booster CpG7909 ODN in HIV Infected and HIV Uninfected People
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Immunologic Effects of CpG ODN Administration to HIV Uninfected and HIV Infected Patients
Status: COMPLETED
Status Verified Date: 2007-12
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 purpose of the study is to determine the safety of and immune response to a hepatitis B virus vaccine series given with a boosting agent CpG7909 oligodeoxynucleotides ODN in HIV infected and HIV uninfected individuals who previously failed to develop a response to hepatitis B vaccine

Study hypothesis Administration of CpG7909 ODN together with recombinant hepatitis B vaccine will result in increased frequency and magnitude of response to vaccine in individuals who have previously failed to mount a response to vaccination and that in HIV infected subjects with detectable plasma viremia it will lead to the enhancement of HIV-specific responses
Detailed Description: As HIV disease progresses in HIV infected people their immune responses to infectious and other foreign invaders becomes weaker in particular the cellular T-cell immune response is particularly affected by HIV A boosting agent called CpG7909 ODN may be an ideal adjuvant for vaccines given to HIV infected people because it may help elicit an increased CD8 T-cell response This study will evaluate the safety of and immune response to a hepatitis B virus vaccine series given with CpG7909 ODN in HIV infected and uninfected people

There will be three groups in this study participants will be stratified by baseline CD4 counts and viral load Within each group participants will be randomly assigned to receive 3 injections of hepatitis B vaccine with CpG7909 ODN or 3 injections of hepatitis B vaccine alone Injections will be given at study entry and Months 1 and 6 There will be 10 study visits a physical exam and blood collection will occur at each visit

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
P01AI055793 NIH None httpsreporternihgovquickSearchP01AI055793