Drugs / Ad26.ZEBOV
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | Ebola hemorrhagic fever | 2019-11-07 | “Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN ® Filo).” bavarian-nordic.com ↗ “Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo).” bavarian-nordic.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02860650 | Aug 2016 → May 2017 | — | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02376400 | Apr → Dec 2015 | — | Crucell Holland BV | Completed | No outcome recorded |
| Phase 1 | NCT02376426 | Mar → Sep 2015 | — | Crucell Holland BV | Completed | No outcome recorded |
| Phase 1 | NCT02325050 | Jan → Jul 2015 | — | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02313077 | Dec 2014 → Apr 2015 | — | Crucell Holland BV | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary | ||||||
| Phase 2 | NCT05284097 | Sep 2022 → Mar 2023 | Ebola hemorrhagic fever | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 2 | NCT05064956 | Oct → Nov 2021 | Ebola hemorrhagic fever, HIV infectious disease | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04711356 | Jul → Sep 2021 | Ebola hemorrhagic fever | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04186000 | Dec 2019 → Apr 2020 | Ebola hemorrhagic fever | University of Antwerp | Completed | No outcome recorded |
| Phase 2 | NCT03929757 | Aug 2019 → Aug 2022 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 2 | NCT02876328 | Mar 2017 → Dec 2019 | Ebola hemorrhagic fever | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT02598388 | Dec 2015 → Dec 2018 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 2 | NCT02564523 | Nov 2015 → Feb 2019 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 2 | NCT02416453 | Jun 2015 → Jan 2018 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 37 trials · 2 missed | ||||||
| Phase 3 | NCT04556526 | Oct 2020 → Mar 2023 | — | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 3 | NCT04228783 | Feb 2020 → Apr 2022 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 3 | NCT04152486 | Nov 2019 → Jan 2022 | Ebola hemorrhagic fever | London School of Hygiene and Tropical Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT02661464 | May 2016 → Dec 2021 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Terminated | No outcome recorded |
| Phase 3 | NCT02509494 | Sep 2015 → Jun 2019 | Ebola hemorrhagic fever | Janssen Vaccines & Prevention B.V. | Completed | No outcome recorded |
| Phase 3 | NCT02543268 | Sep 2015 → Jan 2016 | — | Crucell Holland BV | Completed | Missed primary |
| Phase 3 | NCT02543567 | Sep 2015 → Jun 2016 | — | Janssen Vaccines & Prevention B.V. | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02495246 Comparator | Sep 2015 → Aug 2017 | Ebola hemorrhagic fever | University of Oxford | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2021-10-29 | Janssen Research & Development, LLC | Results Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson & Johnson Ebola Vaccine Regimen in Adults Living with HIV jnj.com ↗
Data published inPLOS Medicinedemonstrated that the Johnson & Johnson (the Company) Ebola vaccine regimen, Zabdeno®(Ad26.ZEBOV) and Mvabea®(MVA-BN-Filo), was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. |
| 2021-09-13 | Janssen Research & Development, LLC | Results Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases jnj.com ↗
The data also showed that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic (immune) response within seven days. |
| 2021-09-13 | Janssen Research & Development, LLC | Results Johnson & Johnson Ebola Vaccine Regimen Demonstrated Robust and Durable Immune Response in Adults and Children in Data Published in The Lancet Infectious Diseases jnj.com ↗
Data show the vaccine regimen induced neutralizing antibody responses in nearly all participating adults and children 21 days after the second dose |
| 2021-06-04 | Janssen Research & Development, LLC | Regulatory Statement on the SAGE Recommendation Regarding the Johnson & Johnson Ebola Vaccine Regimen jnj.com ↗
Johnson & Johnsonwelcomes the recommendationby the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) in support of the use of Johnson & Johnson’s two-dose Ebola vaccine regimen, Zabdeno®(Ad26.ZEBOV) and Mvabea®(MVA-BN-Filo) |
| 2020-07-01 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine jnj.com ↗
Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. |
| 2020-07-01 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine jnj.com ↗
Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease. |
| 2020-07-01 | Bavarian Nordic | Regulatory Bavarian Nordic Announces European Marketing Authorization for Ebola Vaccine bavarian-nordic.com ↗
COPENHAGEN, Denmark, July 1, 2020 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that the European Commission has granted marketing authorization for MVABEA ® (MVA-BN Filo) together with ZABDENO ® (Ad26.ZEBOV), which collectively constitute Janssen’s Ebola vaccine regimen. |
| 2020-05-29 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen jnj.com ↗ |
| 2020-05-29 | Bavarian Nordic | Regulatory Bavarian Nordic Announces that Janssen has Received Positive CHMP Opinion for its Investigational Preventative Ebola Vaccine Regimen bavarian-nordic.com ↗
Janssen Pharmaceutical Companies of Johnson & Johnson has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its investigational Ebola vaccine regimen |
| 2019-11-07 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen’s Investigational Ebola Vaccine Regimen jnj.com ↗
Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). |
| 2019-11-07 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Announces Submission of European Marketing Authorisation Applications for Janssen’s Investigational Ebola Vaccine Regimen jnj.com ↗
Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). |
| 2019-11-07 | Bavarian Nordic | Regulatory Bavarian Nordic Announces Submission of European Marketing Authorisation Applications for Investigational Ebola Vaccine Regimen bavarian-nordic.com ↗
Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN ® Filo). |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ad26.ZEBOV | “The novel 2-dose heterologous Adenovirus type 26.ZEBOV (Ad26.ZEBOV) and modified vaccinia Ankara-BN-Filo (MVA-BN-Filo) vaccine regimen is safe and provides specific immunity...” PMID 32315287 ↗ Jul 2020 |
| Known as | Adenovirus type 26.ZEBOV | “The novel 2-dose heterologous Adenovirus type 26.ZEBOV (Ad26.ZEBOV) and modified vaccinia Ankara-BN-Filo (MVA-BN-Filo) vaccine regimen is safe and provides specific immunity...” PMID 32315287 ↗ Jul 2020 |
| Modality | Vaccine | “an adenovirus type 26 vector vaccine encoding Ebola glycoprotein (Ad26.ZEBOV)” PMID 27092831 ↗ Apr 2016 |
| Route | Intramuscular | “administered intramuscularly (IM) as 2-dose heterologous regimens.” NCT02416453 ↗ |