Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEPLISAV-B · 3 trials · 4 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.
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-B | EXPERIMENTAL | 0.5 mL HEPLISAV-B and 0.5 mL Placebo |
| Engerix-B | ACTIVE_COMPARATOR | 2.0 mL Engerix-B |
| 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 |
| Placebo | OTHER | Placebo(saline) intramuscular (IM) injection at Week 8 |
| 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 an investigational hepatitis B vaccine being studied for use in adults with chronic kidney disease, end-stage renal disease on hemodialysis, and HIV infection. It is developed by Dynavax Technologies Corporation (DVAX) and is currently in clinical development, having completed Phase 3 trials.
HEPLISAV-B is a monoclonal antibody modality vaccine designed to prevent hepatitis B infection. It is being evaluated for its ability to generate an immune response in patients with compromised immune systems, including those with chronic kidney disease, end-stage renal disease, and HIV.
HEPLISAV-B is developed by Dynavax Technologies Corporation, a biopharmaceutical company traded on NASDAQ under the ticker DVAX. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in various patient populations.
HEPLISAV-B has completed Phase 3 clinical trials, including studies in chronic kidney disease patients and in persons living with HIV. It remains an investigational product and has not been reported as FDA approved. Additional Phase 1 studies have also been completed.
HEPLISAV-B has been studied in three completed trials: NCT00985426 in chronic kidney disease patients, NCT03934736 in end-stage renal disease patients on hemodialysis, and NCT04193189 in persons living with HIV. These trials enrolled a total of 638 participants across multiple countries.
HEPLISAV-B is not the same as Engerix-B. In clinical trial NCT00985426, HEPLISAV-B was compared to Engerix-B as an active control to evaluate safety and immunogenicity in chronic kidney disease patients. Both are hepatitis B vaccines, but they are distinct products.