Drugs / HEPLISAV-B
HEPLISAV-B
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Heplisav B | — | 2021-02-18 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04162223 | Mar 2000 → May 2003 | hepatitis B virus infection | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT04843852 | Oct 2025 → Oct 2026 expected | chronic hepatitis B virus infection | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 1 | NCT05727267 | Jan 2024 → May 2026 | chronic hepatitis B virus infection | University Medical Center Hamburg-Eppendorf | Completed | No outcome recorded |
| Phase 1 | NCT04199715 | Dec 2019 → Jan 2022 | hepatitis B virus infection | Baylor Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT03934736 | Apr 2019 → Oct 2020 | end stage renal failure | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06513286 | Jun 2025 → Dec 2026 expected | chronic hepatitis B virus infection | Michael Hoelscher | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03685708 | Dec 2018 → Dec 2020 | hepatitis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT04193189 | Dec 2020 → Aug 2024 | HIV infectious disease, hepatitis B virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT03893448 | Jun 2019 → May 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00985426 | Sep 2009 → Jan 2012 | chronic kidney disease | Dynavax Technologies Corporation | Completed | Met primary |
| Phase 3 | NCT00489099 | Jun 2005 → May 2006 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 4 | NCT04456504 | Sep 2020 → Dec 2023 | — | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT04588077 | Sep 2020 → Dec 2028 expected | cirrhosis of liver, hepatitis B virus infection | Mercy Medical Center | Recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT04385524 | Jun 2020 → Feb 2021 | hepatitis B virus infection | University of Louisville | Withdrawn | No outcome recorded |
| — | NCT02055365 | Feb 2014 → Jan 2015 | hepatitis B virus infection | Rockefeller University | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT00322361 Comparator | May 2006 → Jul 2007 | hepatitis B virus infection, hepatocellular carcinoma | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 2 | NCT00551915 Comparator | May 2001 → Jan 2003 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT03620162 Background | Oct 2018 → Dec 2020 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01340937 Comparator | May 2011 → Dec 2012 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT01337167 Comparator | Apr 2011 → May 2013 | bacterial infectious disease, viral infectious disease | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00440531 Comparator | Nov 2006 → Nov 2007 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00414050 Comparator | Oct 2006 → Oct 2007 | hepatitis B virus infection | Merck Sharp & Dohme LLC | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-10-20 | Merck Sharp & Dohme LLC | Results US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine merck.com ↗
For 18 of these 19 comparisons (all but one pertussis comparison), the antibodies in the Group 1 infants were non-inferior to those in the Group 2 infants. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-10-20 | Merck Sharp & Dohme LLC | US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine merck.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HEPLISAV--B | “This prospective study enrolled healthcare workers (HCWs) who were nonresponders following at least 5 doses of aluminum-adjuvanted hepatitis B vaccine who received the 2-dose...” PMID 38881506 ↗ Aug 202412“Heplisav B is a standard of care vaccine that provides an alternative to a traditional 3-dose series by enabling use of a 2-dose series with doses one and two separated by one month.” NCT04385524 ↗ “We tested an FDA approved immune adjuvanted HBV vaccine (HEPLISAV--B® or HepB-CpG) in medically immune suppressed individuals.” PMID 37353450 ↗ Jun 2023 |
| Known as | Hepatitis B Vaccine \[Recombinant\] | “Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.” NCT00489099 ↗ |
| Known as | HepB | “Recombivax HB (HepB) at 2 and 6 months” PMID 27846058 ↗ Feb 2017 |
| Known as | hepB-CpG | “This prospective study enrolled healthcare workers (HCWs) who were nonresponders following at least 5 doses of aluminum-adjuvanted hepatitis B vaccine who received the 2-dose...” PMID 38881506 ↗ Aug 20241“We tested an FDA approved immune adjuvanted HBV vaccine (HEPLISAV--B® or HepB-CpG) in medically immune suppressed individuals.” PMID 37353450 ↗ Jun 2023 |
| Known as | RECOMBIVAX HB | “received a 0.5-mL intramuscular dose of 5-μg mpHBV, Recombivax-HB (5 μg), 10-μg mpHBV, or Engerix-B (10 μg) at day 1, month 2, and month 4 (2, 4, 6 months of age).” PMID 21552183 ↗ Jul 201110“Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.” NCT00489099 ↗ “All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).” NCT02055365 ↗ |
| Action | Activate | “a toll-like receptor 9 agonist” PMID 23727422 ↗ May 2013 |
| Modality | Vaccine | “recombinant hepatitis B vaccine” NCT00322361 ↗ |
| Route | Intramuscular | “administered via intramuscular injection” NCT00322361 ↗ |
| Target | TLR9 | “it is thought to stimulate the immune system through activation of the toll-like receptor 9 pathway” NCT04588077 ↗ |