Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04843852
Status:
WITHDRAWN
Last Update Posted:
2022-07-22
First Post:
2021-04-06
Brief Title:
TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Augmentation of Humoral Immunity Using Toll-Like Receptor TLR 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not implemented
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOOST-9
Brief Summary:
Unmethylated cystine-guanosine dinucleotide CpG motifs are pathogen-associated molecular patterns PAMPs associated with bacterial and viral-derived DNA that activate the innate and humoral immunity via toll-like receptor 9 This is a randomized controlled pilot study evaluating the clinical and immune correlates of a seroprotective immune response against a CpG-adjuvanted vaccine for hepatitis B
Detailed Description:
This is an open-label randomized pilot study to assess the effect of CpG-adjuvanted vaccination among people with chronic hepatitis B This study will evaluate the effect of CpG-adjuvanted vaccination on B-cells that produce anti-HBsAg antibody
The primary hypothesis is that TLR9 agonism with CpG-adjuvanted hepatitis B vaccine will increase the number of anti-HBsAg producing B-cells in people with chronic hepatitis B infection who are virally suppressed on nucleostide analogue NUC therapy
In this study 40 people with chronic hepatitis B virally suppressed on NUC therapy will be randomized in a 11 fashion to receive an 05ml intramuscular injection of HEPLISAV-B vaccine - an FDA approved vaccine for preventing hepatitis B infection Participants randomized to receive the vaccine will receive a total of 2 injections at day 0 and week 4 Participants will be evaluated at days 7 14 28 35 56 96 393 for adverse events with and blood sample collections on days 0 14 28 56 196
The primary hypothesis is that TLR9 agonism with CpG-adjuvanted hepatitis B vaccine will increase the number of anti-HBsAg producing B-cells in people with chronic hepatitis B infection who are virally suppressed on nucleostide analogue NUC therapy
In this study 40 people with chronic hepatitis B virally suppressed on NUC therapy will be randomized in a 11 fashion to receive an 05ml intramuscular injection of HEPLISAV-B vaccine - an FDA approved vaccine for preventing hepatitis B infection Participants randomized to receive the vaccine will receive a total of 2 injections at day 0 and week 4 Participants will be evaluated at days 7 14 28 35 56 96 393 for adverse events with and blood sample collections on days 0 14 28 56 196
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None