Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HEPLISAV
HEPLISAV-B · 7 trials · 5 indications
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).
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.
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B compared to that after Engerix-B.
Percentage of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 milli-international unit (mIU)/mL) after the final active injection in each treatment group (Week 12 for HEPLISAV™ and Week 28 for Engerix-B®)
Local and Systemic post-injection reactions.
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Group A, 3-alum: ENGERIX-B (three injections) | ACTIVE_COMPARATOR | Participants were prescribed 1 mL of ENGERIX-B (conventional hepatitis B vaccine with an aluminum hydroxide adjuvant) by IM injection at Weeks 0, 4, and 24. |
| Group B: 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. |
| HEPLISAV | EXPERIMENTAL | 0.5 mL HEPLISAV |
| Engerix-B | ACTIVE_COMPARATOR | 2.0 mL Engerix-B |
| Fendrix | ACTIVE_COMPARATOR | 0.5 mL Fendrix |
| HEPLISAV-B | EXPERIMENTAL | 0.5 mL HEPLISAV-B and 0.5 mL Placebo |
| HEPLISAV and/or Placebo | EXPERIMENTAL | 0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) |
| HEPLISAV-B® | EXPERIMENTAL | A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4). |
| Name | Type | Description |
|---|---|---|
| HEPLISAV-B | BIOLOGICAL | Administered by IM injection |
| ENGERIX-B | BIOLOGICAL | Administered by IM injection |
| HEPLISAV | BIOLOGICAL | Intramuscular (IM) injection on Day1 |
| Fendrix | BIOLOGICAL | Intramuscular (IM) injection on Day 1 |
| Placebo | OTHER | Placebo(saline) intramuscular (IM) injection at Week 8 |
| HEPLISAV and/or Placebo | BIOLOGICAL | Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24 |
| HEPLISAV-B® | DRUG | HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg). |
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 * Documentati...
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HEPLISAV-B is a vaccine developed by Dynavax Technologies Corporation (ticker: DVAX) for hepatitis B prevention in adults. It has been studied in patients with chronic kidney disease, end-stage renal disease on hemodialysis, and HIV infection. It is administered to adults 18 years and older.
HEPLISAV-B is developed by Dynavax Technologies Corporation, which trades under the ticker DVAX. The company conducted the clinical development program for the vaccine, including trials in chronic kidney disease, end-stage renal disease on hemodialysis, and HIV infection.
HEPLISAV-B has completed Phase 3 clinical development. Its Phase 3 trials include NCT00985426 in chronic kidney disease patients and NCT04193189 in persons living with HIV. A Phase 1 trial, NCT03934736, evaluated the vaccine in adults with end-stage renal disease undergoing hemodialysis.
HEPLISAV-B has been studied in three completed trials. NCT04193189 was a Phase 3 trial of 638 participants with HIV infection across ten countries. NCT00985426 was a Phase 3 trial of 521 chronic kidney disease patients. NCT03934736 was a Phase 1 trial of 119 adults with end-stage renal disease on hemodialysis.
HEPLISAV-B has been evaluated for hepatitis B vaccination in adults with chronic kidney disease. The Phase 3 trial NCT00985426 compared its safety and immunogenicity to Engerix-B in 521 chronic kidney disease patients. A separate Phase 1 trial studied it in adults with end-stage renal disease undergoing hemodialysis.
Yes, HEPLISAV-B and HEPLISAV-B® refer to the same vaccine from Dynavax Technologies Corporation. The registered trademark symbol is simply part of the product's formal name. Both names appear in the clinical trial records for the same development program.