Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders

NCT05791851 | Completed

• 1 other identifier: HP-83378
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections; Hepatitis B; Vaccine Response Impaired

Keywords

Heplisav-B; HIV; vaccine

Outcome Measures

Primary Outcomes (7)

• Change in B cell functional responses

  Characterize the change in B cell functional responses by ELISpot on day 30 compared to baseline

  Day 30

• Change in B cell functional responses

  Characterize the change in B cell functional responses by ELISpot on day 60 compared to baseline

  Day 60

• Change in B cell functional responses

  Characterize the change in B cell functional responses by ELISpot on day 365 compared to baseline

  Day 365

• 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

• 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

• 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

• Cytokine profile

  Change in cytokine profile on day 1 compared to baseline

  Day 1

Secondary Outcomes (6)

• Hepatitis B surface antibody responses

  Day 30

• Hepatitis B surface antibody responses

  Day 60

• Hepatitis B surface antibody responses

  Day 365

• Hepatitis B surface antibody response rates

  Day 30

• Hepatitis B surface antibody response rates

  Day 60

Study Arms (2)

HIV infected

HIV uninfected

Eligibility Criteria

• Age: 18 Years - 109 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population includes patients (or healthcare providers) who have received prior Hepatitis B vaccines without achieving seroprotection (defined as a negative SAb qualitative titer or a SAb quantitative titer \<10 mIU/mL collected at least 30 days after last vaccine dose). The primary enrollment group will include Veterans living with HIV, with a comparator group of HIV-negative individuals. An additional exploratory population of HBV vaccine nonresponders who were successfully treated for HCV infection may be included to provide an opportunity for evaluation of the immune responses in patients who have been cured of chronic viral infections.

You may qualify if:

• 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.
• Untreated ≥ 8 weeks with CD4 count \>100
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baltimore VA Medical Center: collaborator

Study Sites (2)

Baltimore Veterans Affairs Medical Center

Baltimore, Maryland, 21201, United States

Location

Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 30, 2023
• Study Start: October 23, 2019
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)