HIV Infections Clinical Trial
— HBR2Official title:
Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
NCT number | NCT05791851 |
Other study ID # | HP-83378 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 23, 2019 |
Est. completion date | June 14, 2022 |
Verified date | March 2023 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 14, 2022 |
Est. primary completion date | June 14, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 109 Years |
Eligibility | Inclusion Criteria: - Age >18 by age of screening - If HIV positive, either: - Suppressed on a stable, ARV regimen for >4 weeks with CD4 count >100. HIV VL suppressed <50 copies/mL, although single isolated VL >50 not excluded. OR - Untreated = 8 weeks with CD4 count >100 - Prior HBV vaccine (other than Heplisav) with last dose >30 days prior to screening and anti-HBSAg =10 IU/mL measured >30days from last vaccine dose. (No exclusion for HBV CAb positive.) - Ability to provide informed consent and adhere to clinic visits (in the judgment of both the participant and the provider) - No history of adverse reaction to HBV vaccines or components thereof - If HCV Ab positive: undetectable HCV viral load and >12 weeks from completion of any HCV therapy. Exclusion Criteria: - History of allergic reaction to HBV vaccines or components (including yeast) - HBsAb titer >10 IU/mL on screening evaluation - Clinically significant illness (other than HIV) that may, in the opinion of the investigator, interfere with the subject treatment, or adherence to protocol. This may include but is not limited to a history of transplant, decompensated cirrhosis, or malignancy that may interfere with host immunity. - Poor venous access interfering with blood sample collection - Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent. - No exclusion will be made for chronic renal disease or ESRD |
Country | Name | City | State |
---|---|---|---|
United States | Baltimore Veterans Affairs Medical Center | Baltimore | Maryland |
United States | Institute of Human Virology | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Baltimore Veterans Affairs Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in B cell functional responses | Characterize the change in B cell functional responses by ELISpot on day 30 compared to baseline | Day 30 | |
Primary | Change in B cell functional responses | Characterize the change in B cell functional responses by ELISpot on day 60 compared to baseline | Day 60 | |
Primary | Change in B cell functional responses | Characterize the change in B cell functional responses by ELISpot on day 365 compared to baseline | Day 365 | |
Primary | Change in B cell phenotypic responses | Characterize the change in B cell phenotypic responses by flow cytometry on day 365 compared to baseline | Day 30 | |
Primary | Change in B cell phenotypic responses | Characterize the change in B cell phenotypic responses by flow cytometry on day 365 compared to baseline | Day 60 | |
Primary | Change in B cell phenotypic responses | Characterize the change in B cell phenotypic responses by flow cytometry on day 365 compared to baseline | Day 365 | |
Primary | Cytokine profile | Change in cytokine profile on day 1 compared to baseline | Day 1 | |
Secondary | Hepatitis B surface antibody responses | Characterization of the hepatitis B surface antibody titers on day 30 compared to baseline | Day 30 | |
Secondary | Hepatitis B surface antibody responses | Characterization of the hepatitis B surface antibody titers on day 60 compared to baseline | Day 60 | |
Secondary | Hepatitis B surface antibody responses | Characterization of the hepatitis B surface antibody titers on day 365 compared to baseline | Day 365 | |
Secondary | Hepatitis B surface antibody response rates | Characterization of the hepatitis B surface antibody response rates on day 30 compared to baseline | Day 30 | |
Secondary | Hepatitis B surface antibody response rates | Characterization of the hepatitis B surface antibody response rates on day 60 compared to baseline | Day 60 | |
Secondary | Hepatitis B surface antibody response rates | Characterization of the hepatitis B surface antibody response rates on day 365 compared to baseline | Day 365 |
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