Hepatitis B, HIV Infection
Conditions
Keywords
vaccination, cytosine phosphoguanine adjuvant, seroprotection
Brief summary
The purpose of this study was to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations of people living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.
Detailed description
This phase III/IV study evaluated the response to and safety of the HBV vaccine HEPLISAV-B in two study populations of people living with HIV: prior HBV vaccine recipients who are deemed non-responders (Group A) and individuals who are naïve to HBV vaccination (Group B). The analyses were conducted as separate evaluations of the two study populations for all primary and secondary objectives. Group A (HBV vaccine non-responders) The study was designed as an open-label three-arm study to evaluate whether: 1. HEPLISAV-B vaccination given as a two-dose series achieves non-inferior seroprotection response (SPR) compared to standard dose ENGERIX-B. 2. HEPLISAV-B vaccination given as a three-dose series achieves superior SPR compared to standard dose ENGERIX-B. Participants were randomized in 1:1:1 ratio to the following study arms, stratified by sex at birth (male vs. female) and diabetes diagnosis status (yes vs. no): 2-CpG: Two doses of HEPLISAV-B at weeks 0 and 4. 3-CpG: Three doses of HEPLISAV-B at weeks 0, 4, and 24. 3-alum: Three doses of ENGERIX-B at weeks 0, 4, and 24. The target sample size in Group A was 561 participants, 187 participants in each arm. Group B (Naïve to HBV vaccination) Group B study was a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size was 73 participants. In both groups, participants were scheduled to attend several study visits through Week 72. All participants were to remain on their antiretroviral therapy (ART), not provided by the study, throughout the study. Visits included physical examinations and blood collection. For 7 days after each vaccination, participants were asked to record temperature and any reactions they experienced.
Interventions
BIOLOGICALHEPLISAV-B
Administered by IM injection
BIOLOGICALENGERIX-B
Administered by IM injection
Sponsors
Dynavax Technologies Corporation
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
, Groups A and B * HIV-1 infection * On current HIV-1 antiretroviral therapy (ART) * CD4+ T-cell count ≥100 cells/mm\^3 * HIV-1 RNA \<1000 copies/mL Inclusion Criteria, Group A only * Serum Hepatitis B antibody \<10 mlU/mL, non-reactive (negative), or indeterminate * Documentation of HBV vaccination \>168 days prior to study entry Inclusion Criterion, Group B only * Serum Hepatitis B antibody non-reactive (negative) within 45 days prior to study entry
Exclusion criteria
, Groups A and B * Infection or prior exposure to HBV * Serum HBsAb level ≥10 mlU/mL or positive at screening or any other time prior to screening * Presence of any active or acute AIDS-defining opportunistic infections * Solid organ transplantation * History of ascites, encephalopathy, or variceal hemorrhage * Diagnosis of chronic kidney disease (CKD) stage G4 * Cancer diagnosis within 5 years * Currently receiving chemotherapy * Chronic use and/or receipt of systemically administered immunosuppressive * Known allergy/sensitivity or any hypersensitivity to any HBV vaccine or yeast * Active, serious infection other than HIV-1 * Receipt of any inactivated virus vaccine within 14 days * Receipt of any of the following within 45 days prior to study entry: * Live virus vaccine * Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) * Any other investigational medicinal agent * Receipt of immunoglobulin or blood products within 90 days prior to study entry * Receipt of an injection of DNA plasmids or oligonucleotides within 60 days prior to study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Primary Seroprotection Response | Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B | 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). |
| Percentage of Participants With Adverse Events (AEs) | From study entry to study discontinuation (Week 72 or premature discontinuation) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. This outcome is limited to the Grade ≥2 AEs that occurred within 4 weeks after any study vaccination. 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. |
| 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. | Count of participants by antibody titer against hepatitis B surface antigen (anti-HBs), categorized using cutoffs at 5, 10, 100 and 1000 mIU/mL. The testing assay lower limit of quantitation was 5 mIU/mL and upper limit 1000 mIU/mL. Study visit weeks are according to protocol-specified visit windows; anti-HBs results outside visit windows were not included. Because high proportions of participants achieved anti-HBs above the assay upper limit of quantitation, the planned geometric mean analysis was not conducted. Instead, anti-HBs were summarized according to the categories shown in the Data Table below. |
| 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. | Seroprotection response (SPR) was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL. Study visit weeks are according to protocol-specified visit windows; anti-HBs results outside visit windows were not included. These are snapshots at scheduled visits irrespective of delayed vaccinations, unlike the visits defined in Primary Outcome 1. 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 CIs around the single-arm estimates were specified (presented in the Data Table below). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Subgroup analysis of the primary seroprotection response outcome measure (as described in the Primary Outcome Measure 1 above) by sex. Descriptive summary of the SPR by subgroups; the study was not powered for testing the success of HEPLISAV-B vaccination within subgroups. |
| 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 | Subgroup analysis of the primary seroprotection response outcome measure (as described in the Primary Outcome Measure 1 above) by race. Descriptive summary of the SPR by subgroups; the study was not powered for testing the success of HEPLISAV-B vaccination within subgroups. |
Countries
Botswana, Brazil, Kenya, Malawi, Philippines, South Africa, Thailand, Uganda, United States, Vietnam
Participant flow
Recruitment details
Participants were enrolled from December 2020 to February 2023 at sites in USA and select countries in Africa, Asia and South America.
Participants by arm
| Arm | Count |
|---|---|
| Group A: 2-CpG Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0 and 4. | 187 |
| Group A: 3-CpG Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24. | 188 |
| Group A: 3-alum Participants were prescribed 1 mL of ENGERIX-B (conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant) by intramuscular injection at Weeks 0, 4, and 24. | 186 |
| Group B Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular injection at Weeks 0, 4, and 24. | 74 |
| Total | 635 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 9 | 7 | 9 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Group A: 3-CpG | Total | Group B | Group A: 2-CpG | Group A: 3-alum |
|---|---|---|---|---|---|
| Age, Customized 18-26 years | 34 Participants | 112 Participants | 4 Participants | 42 Participants | 32 Participants |
| Age, Customized 27-39 years | 35 Participants | 112 Participants | 14 Participants | 30 Participants | 33 Participants |
| Age, Customized 40-49 years | 45 Participants | 147 Participants | 30 Participants | 30 Participants | 42 Participants |
| Age, Customized 50-59 years | 53 Participants | 173 Participants | 19 Participants | 58 Participants | 43 Participants |
| Age, Customized ≥60 years | 21 Participants | 91 Participants | 7 Participants | 27 Participants | 36 Participants |
| Anti-HBs <10 mIU/mL | 185 Participants | 623 Participants | 74 Participants | 182 Participants | 182 Participants |
| Anti-HBs ≥10 mIU/mL | 3 Participants | 10 Participants | 0 Participants | 3 Participants | 4 Participants |
| CD4 cell count 200-<350 cells/mm^3 | 13 Participants | 53 Participants | 10 Participants | 19 Participants | 11 Participants |
| CD4 cell count <200 cells/mm^3 | 3 Participants | 16 Participants | 1 Participants | 6 Participants | 6 Participants |
| CD4 cell count 350-<500 cells/mm^3 | 28 Participants | 108 Participants | 11 Participants | 35 Participants | 34 Participants |
| CD4 cell count ≥500 cells/mm^3 | 144 Participants | 458 Participants | 52 Participants | 127 Participants | 135 Participants |
| Diabetes status Diabetes | 23 Participants | 81 Participants | 7 Participants | 25 Participants | 26 Participants |
| Diabetes status No diabetes | 165 Participants | 554 Participants | 67 Participants | 162 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 132 Participants | 11 Participants | 39 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 500 Participants | 63 Participants | 148 Participants | 144 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| HIV-1 RNA <40 copies/mL | 176 Participants | 594 Participants | 68 Participants | 175 Participants | 175 Participants |
| HIV-1 RNA ≥40 copies/mL | 12 Participants | 40 Participants | 5 Participants | 12 Participants | 11 Participants |
| HIV-1 RNA Indeterminate | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 35 Participants | 146 Participants | 49 Participants | 29 Participants | 33 Participants |
| Race/Ethnicity, Customized Black or African American | 76 Participants | 247 Participants | 12 Participants | 85 Participants | 74 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 5 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 7 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 8 Participants | 18 Participants | 1 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 62 Participants | 207 Participants | 11 Participants | 62 Participants | 72 Participants |
| Region of Enrollment Botswana | 9 Participants | 29 Participants | 0 Participants | 10 Participants | 10 Participants |
| Region of Enrollment Brazil | 13 Participants | 37 Participants | 0 Participants | 13 Participants | 11 Participants |
| Region of Enrollment Kenya | 8 Participants | 21 Participants | 0 Participants | 8 Participants | 5 Participants |
| Region of Enrollment Malawi | 5 Participants | 16 Participants | 0 Participants | 5 Participants | 6 Participants |
| Region of Enrollment Philippines | 4 Participants | 6 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment South Africa | 12 Participants | 43 Participants | 6 Participants | 14 Participants | 11 Participants |
| Region of Enrollment Thailand | 17 Participants | 102 Participants | 48 Participants | 18 Participants | 19 Participants |
| Region of Enrollment Uganda | 5 Participants | 14 Participants | 0 Participants | 5 Participants | 4 Participants |
| Region of Enrollment United States | 102 Participants | 332 Participants | 20 Participants | 103 Participants | 107 Participants |
| Region of Enrollment Vietnam | 13 Participants | 35 Participants | 0 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Female | 68 Participants | 242 Participants | 40 Participants | 67 Participants | 67 Participants |
| Sex: Female, Male Male | 120 Participants | 393 Participants | 34 Participants | 120 Participants | 119 Participants |
| Sex/Gender, Customized Cisgender | 181 Participants | 617 Participants | 72 Participants | 184 Participants | 180 Participants |
| Sex/Gender, Customized Not reported | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Transgender spectrum | 6 Participants | 16 Participants | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 187 | 1 / 188 | 0 / 186 | 0 / 74 |
| other Total, other adverse events | 133 / 187 | 146 / 188 | 134 / 186 | 64 / 74 |
| serious Total, serious adverse events | 12 / 187 | 15 / 188 | 11 / 186 | 4 / 74 |
Outcome results
Primary
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.
Time frame: From study entry to study discontinuation (Week 72 or premature discontinuation)
Population: Eligible participants who initiated study vaccination series
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Adverse Events (AEs) | 73.3 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Adverse Events (AEs) | 77.7 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Adverse Events (AEs) | 73.7 percentage of participants |
| Group B | Percentage of Participants With Adverse Events (AEs) | 87.8 percentage of participants |
Primary
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).
Time frame: Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Population: Eligible participants who initiated study vaccination series and had anti-HBs data available at the specified time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response | 93.1 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response | 99.4 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response | 80.6 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response | 100 percentage of participants |
Comparison: Primary objective of Group A97.5% CI: [4.1, 20.9]
Comparison: Primary objective of Group A97.5% CI: [10.4, 26.2]
Comparison: Secondary objective of Group A97.5% CI: [-0.2, 11.8]
Secondary
Count of Participants by Anti-HBs Titer Categories
Count of participants by antibody titer against hepatitis B surface antigen (anti-HBs), categorized using cutoffs at 5, 10, 100 and 1000 mIU/mL. The testing assay lower limit of quantitation was 5 mIU/mL and upper limit 1000 mIU/mL. Study visit weeks are according to protocol-specified visit windows; anti-HBs results outside visit windows were not included. Because high proportions of participants achieved anti-HBs above the assay upper limit of quantitation, the planned geometric mean analysis was not conducted. Instead, anti-HBs were summarized according to the categories shown in the Data Table below.
Time frame: 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.
Population: Eligible participants who initiated study vaccination series, and had anti-HBs data available at the given time point
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 100-1000 mIU/mL | 76 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 100-1000 mIU/mL | 72 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 52: anti-HBs | <5 mIU/mL | 12 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 52: anti-HBs | 5-9 mIU/mL | 5 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 52: anti-HBs | 10-99 mIU/mL | 39 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 52: anti-HBs | 100-1000 mIU/mL | 84 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 52: anti-HBs | >1000 mIU/mL | 22 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | <5 mIU/mL | 16 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 5-9 mIU/mL | 3 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | <5 mIU/mL | 6 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | <5 mIU/mL | 6 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 5-9 mIU/mL | 6 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | >1000 mIU/mL | 41 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | >1000 mIU/mL | 51 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 100-1000 mIU/mL | 81 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | >1000 mIU/mL | 15 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 10-99 mIU/mL | 33 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 10-99 mIU/mL | 45 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | >1000 mIU/mL | 38 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | <5 mIU/mL | 47 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | >1000 mIU/mL | 46 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 10-99 mIU/mL | 29 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 5-9 mIU/mL | 13 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 10-99 mIU/mL | 39 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 100-1000 mIU/mL | 77 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 100-1000 mIU/mL | 85 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 10-99 mIU/mL | 34 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 5-9 mIU/mL | 3 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 100-1000 mIU/mL | 65 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 5-9 mIU/mL | 6 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | <5 mIU/mL | 16 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | <5 mIU/mL | 8 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | >1000 mIU/mL | 18 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 5-9 mIU/mL | 2 Participants |
| Group A: 2-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 10-99 mIU/mL | 31 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 100-1000 mIU/mL | 28 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 100-1000 mIU/mL | 49 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 10-99 mIU/mL | 15 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 10-99 mIU/mL | 27 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | >1000 mIU/mL | 23 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 100-1000 mIU/mL | 70 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 100-1000 mIU/mL | 39 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 5-9 mIU/mL | 3 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 5-9 mIU/mL | 7 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 10-99 mIU/mL | 37 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 10-99 mIU/mL | 25 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | >1000 mIU/mL | 53 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | <5 mIU/mL | 5 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | <5 mIU/mL | 6 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | >1000 mIU/mL | 48 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 5-9 mIU/mL | 6 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | <5 mIU/mL | 2 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 10-99 mIU/mL | 38 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 100-1000 mIU/mL | 71 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 10-99 mIU/mL | 8 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 10-99 mIU/mL | 46 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | >1000 mIU/mL | 127 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | >1000 mIU/mL | 112 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | <5 mIU/mL | 3 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | <5 mIU/mL | 9 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 5-9 mIU/mL | 1 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | <5 mIU/mL | 52 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | >1000 mIU/mL | 79 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | <5 mIU/mL | 1 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | <5 mIU/mL | 5 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 100-1000 mIU/mL | 68 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | >1000 mIU/mL | 49 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | >1000 mIU/mL | 55 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 10-99 mIU/mL | 6 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 100-1000 mIU/mL | 79 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 5-9 mIU/mL | 7 Participants |
| Group A: 3-CpG | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 100-1000 mIU/mL | 76 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 100-1000 mIU/mL | 48 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | >1000 mIU/mL | 18 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 100-1000 mIU/mL | 46 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | >1000 mIU/mL | 29 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | <5 mIU/mL | 47 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 10-99 mIU/mL | 42 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 5-9 mIU/mL | 13 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 10-99 mIU/mL | 28 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 5-9 mIU/mL | 10 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 10-99 mIU/mL | 27 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | <5 mIU/mL | 45 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 5-9 mIU/mL | 11 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | >1000 mIU/mL | 24 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | <5 mIU/mL | 53 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 100-1000 mIU/mL | 39 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | >1000 mIU/mL | 17 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | <5 mIU/mL | 80 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 5-9 mIU/mL | 4 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 10-99 mIU/mL | 36 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 100-1000 mIU/mL | 36 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | <5 mIU/mL | 52 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 5-9 mIU/mL | 10 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 10-99 mIU/mL | 36 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 5-9 mIU/mL | 9 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 100-1000 mIU/mL | 50 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | >1000 mIU/mL | 19 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | <5 mIU/mL | 50 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 10-99 mIU/mL | 50 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 100-1000 mIU/mL | 42 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | >1000 mIU/mL | 9 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | <5 mIU/mL | 25 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 5-9 mIU/mL | 7 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 100-1000 mIU/mL | 43 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | >1000 mIU/mL | 57 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | <5 mIU/mL | 31 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 100-1000 mIU/mL | 47 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | >1000 mIU/mL | 46 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 10-99 mIU/mL | 32 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 5-9 mIU/mL | 12 Participants |
| Group A: 3-alum | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 10-99 mIU/mL | 32 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 5-9 mIU/mL | 5 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | <5 mIU/mL | 46 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 10-99 mIU/mL | 10 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 100-1000 mIU/mL | 34 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | >1000 mIU/mL | 27 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 100-1000 mIU/mL | 32 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | >1000 mIU/mL | 57 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | >1000 mIU/mL | 19 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | <5 mIU/mL | 1 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | >1000 mIU/mL | 39 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 10-99 mIU/mL | 10 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | <5 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 10-99 mIU/mL | 5 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 5-9 mIU/mL | 1 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | 100-1000 mIU/mL | 25 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 48: anti-HBs | <5 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 10-99 mIU/mL | 2 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | >1000 mIU/mL | 56 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 10-99 mIU/mL | 24 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 28: anti-HBs | 100-1000 mIU/mL | 9 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 100-1000 mIU/mL | 11 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 10-99 mIU/mL | 2 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 72: anti-HBs | 5-9 mIU/mL | 1 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 10-99 mIU/mL | 19 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 100-1000 mIU/mL | 38 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | <5 mIU/mL | 4 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 5-9 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 12: anti-HBs | >1000 mIU/mL | 11 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | >1000 mIU/mL | 8 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 32: anti-HBs | <5 mIU/mL | 0 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | <5 mIU/mL | 1 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 5-9 mIU/mL | 2 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | <5 mIU/mL | 7 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | >1000 mIU/mL | 4 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 4: anti-HBs | 100-1000 mIU/mL | 8 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 8: anti-HBs | 100-1000 mIU/mL | 28 Participants |
| Group B | Count of Participants by Anti-HBs Titer Categories | Week 24: anti-HBs | 10-99 mIU/mL | 14 Participants |
Secondary
Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events
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. This outcome is limited to the Grade ≥2 AEs that occurred within 4 weeks after any study vaccination. 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.
Time frame: 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)
Population: Eligible participants who initiated study vaccination series
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events | 33.7 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events | 45.7 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events | 43.5 percentage of participants |
| Group B | Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events | 48.6 percentage of participants |
Secondary
Percentage of Participants With Seroprotection Response
Seroprotection response (SPR) was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL. Study visit weeks are according to protocol-specified visit windows; anti-HBs results outside visit windows were not included. These are snapshots at scheduled visits irrespective of delayed vaccinations, unlike the visits defined in Primary Outcome 1. 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 CIs around the single-arm estimates were specified (presented in the Data Table below).
Time frame: 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.
Population: Eligible participants who initiated study vaccination series, and had anti-HBs data available at the given time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 28: SPR | 92.6 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 24: SPR | 95.1 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 12: SPR | 93.6 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 8: SPR | 89.1 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 52: SPR | 89.5 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 72: SPR | 86.1 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Seroprotection Response | Week 4: SPR | 66.1 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 28: SPR | 99.4 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 12: SPR | 92.9 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 24: SPR | 95.0 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 8: SPR | 90.8 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 32: SPR | 98.8 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 72: SPR | 96.9 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 4: SPR | 66.7 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Seroprotection Response | Week 48: SPR | 97.6 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 48: SPR | 65.0 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 72: SPR | 57.5 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 24: SPR | 61.6 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 28: SPR | 80.0 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 32: SPR | 74.5 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 12: SPR | 66.5 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 4: SPR | 51.7 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Seroprotection Response | Week 8: SPR | 64.2 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 28: SPR | 100 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 24: SPR | 98.5 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 48: SPR | 98.6 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 72: SPR | 97.2 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 32: SPR | 100 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 8: SPR | 87.0 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 12: SPR | 94.4 percentage of participants |
| Group B | Percentage of Participants With Seroprotection Response | Week 4: SPR | 30.1 percentage of participants |
Comparison: Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)97.5% CI: [0.1, 18.1]
Comparison: Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)97.5% CI: [10, 27.9]
Comparison: Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)97.5% CI: [17.7, 37.2]
Comparison: Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)97.5% CI: [21.3, 42.3]
Comparison: Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)97.5% CI: [15.5, 32.3]
Comparison: Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)97.5% CI: [23.2, 41.2]
Comparison: Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)97.5% CI: [28.9, 48.1]
Comparison: Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)97.5% CI: [3.1, 16.4]
Comparison: Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)97.5% CI: [-0.8, 10.5]
Comparison: Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)97.5% CI: [-0.8, 11.2]
Comparison: Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)97.5% CI: [0.7, 14.2]
Other Pre-specified
Percentage of Participants With Primary Seroprotection Response by Race
Subgroup analysis of the primary seroprotection response outcome measure (as described in the Primary Outcome Measure 1 above) by race. Descriptive summary of the SPR by subgroups; the study was not powered for testing the success of HEPLISAV-B vaccination within subgroups.
Time frame: Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Population: Eligible participants who initiated study vaccination series and had anti-HBs data available at the specified time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Black race | 97.5 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Other or Unknown race | 63.6 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Asian race | 96.4 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among White race | 90.7 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Asian race | 100 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Black race | 100 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among White race | 98.0 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Race | Among Other or Unknown race | 100 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Race | Among Asian race | 80.0 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Race | Among White race | 67.7 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Race | Among Black race | 92.3 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Race | Among Other or Unknown race | 100 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Race | Among Black race | 100 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Race | Among White race | 100 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Race | Among Other or Unknown race | 100 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Race | Among Asian race | 100 percentage of participants |
Other Pre-specified
Percentage of Participants With Primary Seroprotection Response by Sex
Subgroup analysis of the primary seroprotection response outcome measure (as described in the Primary Outcome Measure 1 above) by sex. Descriptive summary of the SPR by subgroups; the study was not powered for testing the success of HEPLISAV-B vaccination within subgroups.
Time frame: Week 12 in Group A 2-CpG, Week 28 in Group A 3-CpG and 3-alum and in Group B
Population: Eligible participants who initiated study vaccination series and had anti-HBs data available at the specified time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Sex | Among females | 98.4 percentage of participants |
| Group A: 2-CpG | Percentage of Participants With Primary Seroprotection Response by Sex | Among males | 90.0 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Sex | Among males | 100 percentage of participants |
| Group A: 3-CpG | Percentage of Participants With Primary Seroprotection Response by Sex | Among females | 98.5 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Sex | Among females | 89.7 percentage of participants |
| Group A: 3-alum | Percentage of Participants With Primary Seroprotection Response by Sex | Among males | 75.7 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Sex | Among females | 100 percentage of participants |
| Group B | Percentage of Participants With Primary Seroprotection Response by Sex | Among males | 100 percentage of participants |