HEPLISAV vs Engerix-B: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0618 | 0.0557 | 0.0684 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0532 | 0.0455 | 0.0622 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00853 | -0.00227 | 0.0187 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.962 | 1.4 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.96 | 1.43 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on HEPLISAV than on Engerix-B | 117 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | HEPLISAV | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)~HEPLISAV and/or Placebo: Intramuscular (IM) injections at Week 0, Week 4, plus a placebo (saline) injection at Week 24 | 345 | 5,587 | EG000 | ClinicalTrials.gov |
| Group 2 | Engerix-B | 1.0 mL Engerix-B~Engerix-B: Intramuscular injections at Week 0, Week 4, and Week 24 | 148 | 2,781 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Through Week 56 | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine | ClinicalTrials.gov |
| NCT number | NCT02117934 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Healthy | ClinicalTrials.gov |
| Interventions | HEPLISAV, Engerix-B | ClinicalTrials.gov |
| Lead sponsor | Dynavax Technologies Corporation | ClinicalTrials.gov |
| Results first posted | 2018-01-10 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02117934?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.