Trial · NCT01005407
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
NCT01005407, Phase 3, Completed, Dynavax Technologies Corporation; results first posted 2018-01-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine. Trials, record NCT01005407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01005407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
- NCT number
- NCT01005407
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,452 participants, actual
- Lead sponsor
- Dynavax Technologies Corporation
- Conditions
- Healthy
- Interventions
- HEPLISAV and/or Placebo, Engerix-B
- First posted
- 2009-11-02
- Last updated
- 2019-03-20
- Results first posted
- 2018-01-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Have a Seroprotective Immune Response | at Week 12 and at Week 32 | Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody≥ 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B® |
| Secondary | Percentage of Participants With Local and Systemic Reaction to Injections | within 7 days for post-injection reactions |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Who Have a Seroprotective Immune Response | at Week 12 and at Week 32 | Non-Inferiority per Protocol population:Randomized subjects who received 1 of 3 consistency lots of HEPLISAV or Engerix-B within the study visit windows, had all 3 study injections as randomized and within the study visit windows, no major protocol deviations, and anti-HBs levels obtained within study visit windows at baseline, Week 12, and Week 32 | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Local and Systemic Reaction to Injections | within 7 days for post-injection reactions | Safety population: All participants who received at least 1 study injection and had at least 1 post-baseline safety data. NOTE: Only subjects with non-missing injection results in the Safety population are included in this analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Have a Seroprotective Immune Response | HEPLISAV and Placebo | 90.1 | Percentage of participants | ||
| Percentage of Subjects Who Have a Seroprotective Immune Response | Engerix-B | 70.5 | Percentage of participants | ||
| Percentage of Participants With Local and Systemic Reaction to Injections | HEPLISAV and Placebo | Local reaction: Injection 1 | 24.33 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | Engerix-B | Local reaction: Injection 1 | 18.87 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | HEPLISAV and Placebo | Local reaction: Injection 2 | 23.10 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | Engerix-B | Local reaction: Injection 2 | 16.16 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | HEPLISAV and Placebo | Local reaction: Injection 3 | 0 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | Engerix-B | Local reaction: Injection 3 | 13.84 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | HEPLISAV and Placebo | Systemic reaction: Injection 1 | 22.34 | percentage of participants | |
| Percentage of Participants With Local and Systemic Reaction to Injections | Engerix-B | Systemic reaction: Injection 1 | 22.64 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HEPLISAV and/or Placebo | 1,969 | |
| Overall Study | STARTED | Engerix-B | 483 | |
| Overall Study | COMPLETED | HEPLISAV and/or Placebo | 1,818 | |
| Overall Study | COMPLETED | Engerix-B | 451 | |
| Overall Study | NOT COMPLETED | HEPLISAV and/or Placebo | 151 | |
| Overall Study | NOT COMPLETED | Engerix-B | 32 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | HEPLISAV and/or Placebo | 80 | 1,968 | |
| other | Nasopharyngitis | Infections and infestations | Engerix-B(1) | 25 | 481 | |
| serious | Anaemia | Blood and lymphatic system disorders | HEPLISAV and/or Placebo | 0 | 1,968 | |
| serious | Anaemia | Blood and lymphatic system disorders | Engerix-B(1) | 1 | 481 | |
| serious | Acute myocardial infarction | Cardiac disorders | HEPLISAV and/or Placebo | 2 | 1,968 | |
| serious | Acute myocardial infarction | Cardiac disorders | Engerix-B(1) | 1 | 481 | |
| serious | Angina pectoris | Cardiac disorders | HEPLISAV and/or Placebo | 1 | 1,968 | |
| serious | Angina pectoris | Cardiac disorders | Engerix-B(1) | 0 | 481 | |
| serious | Angina unstable | Cardiac disorders | HEPLISAV and/or Placebo | 0 | 1,968 | |
| serious | Angina unstable | Cardiac disorders | Engerix-B(1) | 1 | 481 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HEPLISAV and/or Placebo | ||
| Total, all-cause mortality | Engerix-B(1) | ||
| Total, other adverse events | HEPLISAV and/or Placebo | 80 | 1,968 |
| Total, other adverse events | Engerix-B(1) | 25 | 481 |
| Total, serious adverse events | HEPLISAV and/or Placebo | 78 | 1,968 |
| Total, serious adverse events | Engerix-B(1) | 23 | 481 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23727002 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| HEPLISAV and/or Placebo vs Engerix-B(1): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01005407
GET https://conductscience.org/api/trials/v1/NCT01005407/events?page=2