Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
NCT02003703 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2019-01-31
Summary
Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.
Conditions
Interventions
- BIOLOGICAL
-
Recombinant Hepatitis B Virus Vaccine
Sponsors & Collaborators
-
Roche Pharma AG
collaborator INDUSTRY - collaborator INDUSTRY
-
Aclin Laboratory
collaborator OTHER -
Universidad de Valparaiso
lead OTHER
Principal Investigators
-
Francisco Fuster, MD · Hospital Gustavo Fricke, Viña del Mar, Chile
-
Jose I Vargas, MD · Escuela de Medicina, Universidad de Valparaíso, Chile
-
Daniela Jensen, MD · Escuela de Medicina, Universidad de Valparaíso
-
Felipe T Martinez, MD · Centro de Investigaciones Biomédicas, Escuela de Medicina, Universidad de Valparaíso
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2018-06-30
- Completion
- 2018-12-31
Countries
- Chile
Study Locations
More Related Trials
-
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
NCT05561673 ·Status: COMPLETED ·Phase: PHASE1
-
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
NCT00291876 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants
NCT00697125 ·Status: COMPLETED ·Phase: PHASE2
-
Hepatitis B Vaccination in HIV-infected Persons
NCT00230061 ·Status: COMPLETED ·Phase: PHASE4
-
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
NCT00697840 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
NCT00697229 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
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
-
Heplisav-B Revaccination for Hepatitis B Vaccine Nonresponders
NCT05791851 ·Status: COMPLETED
-
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
NCT00698087 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
NCT00805389 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
NCT00696917 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
NCT00697216 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
NCT00684671 ·Status: COMPLETED ·Phase: PHASE4
-
Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration.
NCT05142553 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
NCT00289718 ·Status: COMPLETED ·Phase: PHASE3
-
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults
NCT00696891 ·Status: COMPLETED ·Phase: PHASE3
-
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
NCT00289744 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y
NCT00698061 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to Aventis Pasteur MSD's Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Responded to Previous Hepatitis B Vaccination But Lost Antibody.
NCT00291980 ·Status: COMPLETED ·Phase: PHASE3
-
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
-
Study to Evaluate Induction of HBV Virus Neutralizing Antibodies Using VVX001
NCT03625934 ·Status: UNKNOWN ·Phase: PHASE2
-
Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders
NCT00697931 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
NCT00289770 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
NCT00519649 ·Status: COMPLETED ·Phase: PHASE4