Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05791851
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2023-03-07
Brief Title:
Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
Status:
COMPLETED
Status Verified Date:
2023-03
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:
HBR2
Brief Summary:
The goal of this natural history study is to examine the immune responses to the Heplisav-B vaccine in Veterans living with HIV who were non-responders to prior HBV vaccination A comparison group of HBV vaccine nonresponders without HIV infection will be enrolled to characterize the HIV-associated immune alterations that affect vaccine response The investigators hypothesize that TLR9-mediated innate immune stimulation with Heplisav will elicit HBV seroprotection despite prior vaccination failures in persons living with HIV compared to HIV uninfected individuals
Participants eligible for Heplisav-B vaccination will be asked to provide blood samples at multiple timepoints before and after their vaccination
Participants eligible for Heplisav-B vaccination will be asked to provide blood samples at multiple timepoints before and after their vaccination
Detailed Description:
HIV-positive individuals are at increased risk of morbidity and mortality from Hepatitis B co-infection due to shared routes of transmission increased likelihood of developing chronic infection as opposed to spontaneous clearance and increased immune dysregulation leading to accelerated disease progression and so current guidelines recommend the routine vaccination of HIV-positive individuals against HBV However because achieved seroprotection rates SPR are historically lower than in HIV-negative individuals post-vaccination serologic testing is recommended for this group and re-vaccination with increased dose or additional doses should be attempted for those who were non-responders to the initial vaccine Heplisav-B is a HBV vaccine adjuvanted with a TLR9 agonist that has shown improved SPR among groups with reduced response rates to classic alum-adjuvanted vaccines such as those with CKD obesity or diabetes The investigators propose to evaluate immunological mechanisms of protection in Veterans who were non-responders to prior HBV vaccination now receiving Heplisav vaccinations The investigators will enroll a comparison group of HIV-negative individuals to characterize the HIV-associated immune alterations that modulate vaccine response The investigators hypothesize that TLR9-mediated innate immune stimulation with Heplisav will elicit HBV seroprotection despite prior vaccination failures in persons living with HIV compared to HIV uninfected individuals By assessing innate immune responses and B cell immunophenotypes at baseline post-vaccination and at long-term followup in Veterans with and without HIV the investigators will assess the mechanisms by which the immunostimulatory effects of TLR9 agonists may overcome the immune dysfunction in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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