Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
NCT05791851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31
Last updated 2023-03-30
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
Sponsors & Collaborators
-
Baltimore VA Medical Center
collaborator FED -
University of Maryland, Baltimore
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 109 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-10-23
- Primary Completion
- 2022-06-14
- Completion
- 2022-06-14
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
NCT00435812 ·Status: COMPLETED ·Phase: PHASE3
-
Trial Comparing Two Strategies of Vaccination Against Hepatitis B in HIV-infected Patients Non Responding to Primary Immunization (B-BOOST)
NCT00670839 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine
NCT02117934 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease
NCT00498212 ·Status: TERMINATED ·Phase: PHASE2
-
HBV Vaccination in HIV-infected Adults
NCT03212911 ·Status: UNKNOWN ·Phase: PHASE4
-
Compare the Immune Response & Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine vs Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis & Dialysis Patients Who Did Not Respond to Previous Hepatitis B Vaccination
NCT00291954 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
NCT02003703 ·Status: COMPLETED ·Phase: PHASE3
-
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
NCT00175435 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
New Methods to Measure the Immune Response to Hepatitis B Vaccine
NCT01821547 ·Status: COMPLETED ·Phase: PHASE4
-
Duration of Long-term Immunity After Hepatitis B Virus Immunization
NCT01182311 ·Status: COMPLETED
-
Immunity to Hepatitis B Vaccine
NCT03083158 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
NCT00697125 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
NCT03866187 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
NCT00697931 ·Status: COMPLETED ·Phase: PHASE3
-
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
NCT01777295 ·Status: COMPLETED ·Phase: PHASE2
-
Cellular Immunity in Adult Hepatitis B-vaccinated Serologic Non-responders
NCT01451801 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
NCT01005407 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
NCT00697749 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
NCT00426712 ·Status: COMPLETED ·Phase: PHASE1
-
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
NCT00698061 ·Status: COMPLETED ·Phase: PHASE3
-
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
NCT00356564 ·Status: COMPLETED ·Phase: PHASE4
-
Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
NCT01259453 ·Status: COMPLETED ·Phase: PHASE4
-
Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
NCT02055365 ·Status: COMPLETED ·Phase: NA
-
Evaluate Immune Response Approximately 5 to 6 Years After Receiving Different Formulations of GSK Bio Hep B Vaccine
NCT00329576 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
NCT00697853 ·Status: COMPLETED ·Phase: PHASE2