Conditions

Hepatitis B HIV Infection

Keywords

vaccinationcytosine phosphoguanine adjuvantseroprotection

Outcome Measures

Primary Outcomes (2)

Percentage of Participants With Primary Seroprotection Response
Primary seroprotection response was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL at 8 weeks after 2-dose vaccination series and at 4 weeks after 3-dose vaccination series. If the completion of the vaccine series was delayed (a delay of ≤4 weeks was allowed), the trial protocol specified obtaining an antibody result at 8 weeks for the 2-dose series or at 4 weeks for the 3-dose series after vaccine completion for use in the primary outcome analysis. The study was designed separately for the two study populations (Groups A and B), and the analysis was conducted separately, as prespecified in the study protocol and Statistical Analysis Plan (SAP). In Group A, two-sided 97.5% confidence intervals (CI) were specified for the SPR differences between study arms (presented in the Statistical Analyses sections below). In Group B, two-sided 95% Wilson CI around the single-arm estimate was specified (presented in the Data Table below).
Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Percentage of Participants With Adverse Events (AEs)
The protocol required reporting of (1) Grade ≥2 AEs, (2) AEs that led to a change in study treatment regardless of grade, (3) AEs meeting serious AE (SAE) definition or expedited AE (EAE) reporting requirement, (4) Grade ≥1 local and systemic injection reactions within 7 days of any study vaccine injection, (5) medically attended adverse events (MAAE) regardless of grade, and (6) potential immune-mediated AEs regardless of grade. Grading was per DAIDS AE Grading Table (Version 2.1): Grade 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening) and 5 (death). DAIDS EAE Manual (V1.0) was used. Wilson method was used for confidence intervals.

Secondary Outcomes (3)

Percentage of Participants With Seroprotection Response
Weeks 4, 8, 12, 24, 28, 32 (Group A 3-CpG and 3-alum and Group B), 48 (Group A 3-CpG and 3-alum and Group B), 52 (Group A 2-CpG) and 72. The visit schedule differed between the study arms.
Count of Participants by Anti-HBs Titer Categories
Weeks 4, 8, 12, 24, 28, 32 (Group A 3-CpG and 3-alum and Group B), 48 (Group A 3-CpG and 3-alum and Group B), 52 (Group A 2-CpG) and 72. The visit schedule differed between the study arms.
Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events
From study vaccination initiation to 4 weeks after last study vaccination (Week 8 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and Group B)

Other Outcomes (2)

Percentage of Participants With Primary Seroprotection Response by Sex
Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Percentage of Participants With Primary Seroprotection Response by Race
Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B

Study Arms (4)

Group A, 2-CpG: HEPLISAV-B (two injections)

EXPERIMENTAL

Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular (IM) injection at Weeks 0 and 4.

Biological: HEPLISAV-B

Group A, 3-CpG: HEPLISAV-B (three injections)

EXPERIMENTAL

Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by IM injection at Weeks 0, 4, and 24.

Biological: HEPLISAV-B

Group A, 3-alum: ENGERIX-B (three injections)

ACTIVE COMPARATOR

Interventions

HEPLISAV-BBiological

Administered by IM injection

Group A, 2-CpG: HEPLISAV-B (two injections)Group A, 3-CpG: HEPLISAV-B (three injections)Group B: HEPLISAV-B (three injections)

ENGERIX-BBiological

Administered by IM injection

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

HIV-1 infection
On current HIV-1 antiretroviral therapy (ART)

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
NIHlead
Dynavax Technologies Corporation
Industrycollaborator

Study Sites (41)

Alabama CRS

Birmingham, Alabama, 35222, United States

UCLA CARE Center CRS

Los Angeles, California, 90035-4709, United States

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Ucsf Hiv/Aids Crs

San Francisco, California, 94110, United States

Harbor-UCLA CRS

Torrance, California, 90502, United States

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Whitman-Walker Health CRS

Washington D.C., District of Columbia, 20005, United States

Related Publications (3)

Marks KM, Kang M, Umbleja T, Avihingsanon A, Sugandhavesa P, Cox AL, Vigil K, Perazzo H, Price JC, Katsidzira L, Vernon C, Alston-Smith B, Sherman KE; ACTG 5379 Study Team. Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naive People With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Aug 14;77(3):414-418. doi: 10.1093/cid/ciad201.
PMID: 37017075RESULT
Marks KM, Kang M, Umbleja T, Cox A, Vigil KJ, Ta NT, Omoz-Oarhe A, Perazzo H, Kosgei J, Hatlen T, Price J, Katsidzira L, Supparatpinyo K, Knowles K, Alston-Smith BL, Rathod P, Sherman KE; ACTG 5379 (BEe-HIVe) Study Team. HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial. JAMA. 2025 Jan 28;333(4):295-306. doi: 10.1001/jama.2024.24490.
PMID: 39616603

MeSH Terms

Conditions

HIV InfectionsHepatitis B

Interventions

Heplisav-BEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital Diseases

Results Point of Contact

Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company

Study Officials

Kenneth E. Sherman, MD, PhD
Cincinnati CRS
STUDY CHAIR
Kristen Marks, MD
Weill Cornell Chelsea CRS
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Other Outcomes (2)

Study Arms (4)

Group A, 2-CpG: HEPLISAV-B (two injections)

Group A, 3-CpG: HEPLISAV-B (three injections)

Group A, 3-alum: ENGERIX-B (three injections)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Group B: HEPLISAV-B (three injections)

You may not qualify if:

Data Sharing

Source record

Documents

Locations