Drugs / IMVAMUNE
IMVAMUNE
also known as
MVA-BN · JYNNEOS · Modified Vaccinia Ankara · CV301 · Modified Vaccinia Ankara-Bavarian Nordic · MVA · Bavarian Nordic smallpox vaccine · Imvanex · +5 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Imvanex | — | 2013-07-31 | europa.eu ↗ |
Trials 34 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06366672 | Jun 2024 → Sep 2026 expected | vaccinia | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03953196 | Apr → Dec 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT02840994 | Dec 2016 → Jan 2020 | non-small cell lung carcinoma | Bavarian Nordic | Completed | No outcome recorded |
| Phase 1 | NCT00565929 | Sep 2008 → May 2012 | variola major infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00082446 | May 2004 → Aug 2007 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00189917 | Apr 2004 → Dec 2005 | allergic rhinitis, atopic eczema | Bavarian Nordic | Completed | No outcome recorded |
| Phase 1 | NCT00189943 | Apr 2001 → Jul 2003 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04410874 | Nov 2020 → May 2023 | basal cell carcinoma, skin squamous cell carcinoma | Ivan Litvinov | Terminated | No outcome recorded |
| Phase 1/2 | NCT01461447 | Mar → May 2012 | — | Muhimbili University of Health and Allied Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT00437021 | Apr 2007 → Apr 2009 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT00189904 | Jul 2005 → ? | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT06839989 | Aug 2025 → May 2026 overdue | monkeypox | Institute of Tropical Medicine, Belgium | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06549530 | Oct 2024 → May 2026 overdue | monkeypox | Bavarian Nordic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05740982 | Mar 2023 → Aug 2024 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT05512949 | Sep 2022 → Oct 2023 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT03315871 | Mar 2018 → Jun 2024 | prostate cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT02038881 | Apr 2014 → May 2017 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT01827371 | Jun 2013 → Apr 2015 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01668537 | Mar 2013 → Jan 2014 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00914732 | Feb 2010 → Apr 2011 | smallpox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00857493 | Jun 2009 → Aug 2010 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00686582 | Aug → Dec 2008 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00316602 | Jul 2006 → Nov 2009 | atopic eczema | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00316589 | Jun 2006 → Mar 2009 | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 2 | NCT00316524 | Apr 2006 → Feb 2007 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06844500 | Jun 2025 → Jun 2026 overdue | — | Jean-Pierre Van geertruyden | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06844487 | May 2025 → Jun 2026 overdue | monkeypox | Jean-Pierre Van geertruyden | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02977715 | Feb 2017 → Oct 2025 | monkeypox | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 3 | NCT01913353 | Mar 2015 → Mar 2017 | — | Bavarian Nordic | Completed | No outcome recorded |
| Phase 3 | NCT01144637 | Feb → Nov 2013 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06829238 | Apr 2025 → Nov 2028 expected | HIV infectious disease, autoinflammatory syndrome, immune dysregulation, autoimmunity, and autoinflammation | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT05745987 | Sep 2024 → Jun 2026 overdue | monkeypox | McMaster University | Recruiting | No outcome recorded |
| Phase 4 | NCT05734508 | Mar 2023 → Jun 2024 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT03472014 | Apr 2010 → Nov 2014 | — | Bavarian Nordic | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00390078 Comparator | Jan → Dec 2007 | HIV infectious disease | Bavarian Nordic | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07253675 Comparator | Dec 2025 → Feb 2027 expected | monkeypox | Shanghai Institute Of Biological Products | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07199569 Comparator | Oct 2025 → Nov 2026 expected | monkeypox | Bavarian Nordic | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00189956 Comparator | Apr → Nov 2003 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03699124 Comparator | Jun 2019 → Jan 2020 | smallpox | Bavarian Nordic | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMVAMUNE | “This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system).” NCT00914732 ↗17“Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.” NCT00082446 ↗ “Imvamune (licensed name of MVA being developed as a smallpox vaccine)” NCT01827371 ↗ “IMVAMUNE® Vaccinia Vaccine delivered by subcutaneous (SC) route” NCT00437021 ↗ “MVA-BN® (IMVAMUNE)” NCT00316524 ↗ |
| Known as | Bavarian Nordic smallpox vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05745987 ↗ |
| Known as | CV301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03315871 ↗ |
| Known as | Imvanex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03953196 ↗ |
| Known as | JYNNEOS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06366672 ↗ |
| Known as | Modified Vaccinia Ankara | “The approved liquid-frozen formulation of Bavarian Nordic's Modified Vaccinia Ankara (MVA-BN) smallpox vaccine has specific cold-chain requirements” PMID 36460535 ↗ Nov 20224“In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 2016 “the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart” NCT06839989 ↗ “investigate the safety and immunogenicity of modified vaccinia Ankara (MVA)” PMID 25149431 ↗ Aug 2014 |
| Known as | Modified Vaccinia Ankara Smallpox Vaccine | “Modified Vaccinia Ankara Smallpox Vaccine” NCT04410874 ↗ |
| Known as | Modified Vaccinia Ankara Virus | “All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).” NCT06549530 ↗ |
| Known as | Modified Vaccinia Ankara-Bavarian Nordic | “The MVA-BN vaccine, with the active ingredient: Modified Vaccinia Ankara-Bavarian Nordic, will be administered as a standard two-dose regimen at 1x10\^8 TCID50 Inf.U./0.5 mL.” NCT06844487 ↗1“JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine” NCT06366672 ↗ |
| Known as | Modified virus Ankara (MVA)-BN | “Modified virus Ankara (MVA)-BN, a highly attenuated strain of vaccinia virus, was developed for vaccination with improved safety profile.” PMID 27357167 ↗ Jun 2016 |
| Known as | MVA | “In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 20161“Imvamune (licensed name of MVA being developed as a smallpox vaccine)” NCT01827371 ↗ |
| Known as | MVA-BN | “MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the...” NCT07199569 ↗20“All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).” NCT06549530 ↗ “In this Phase II trial, the safety and immunogenicity of Modified Vaccinia Ankara MVA-BN® (MVA) was assessed in a 56-80 years old population.” PMID 27327616 ↗ Jun 2016 “liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects” NCT01668537 ↗ “MVA-BN, a highly attenuated strain of vaccinia virus, was developed for vaccination with improved safety profile.” PMID 27357167 ↗ Jun 2016 “Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.” NCT00082446 ↗ “JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine” NCT06366672 ↗ “IMVAMUNE (MVA-BN)” NCT00189956 ↗ “IMVAMUNE (MVA-BN)” NCT00189904 ↗ “IMVAMUNE (MVA-BN)” NCT00316589 ↗ |
| Known as | MVA-BN (CEF) | “MVA-BN manufactured in primary CEF cells. MVA-BN (CEF) vaccine contains 0.5 × 10E8 to 3.95 × 10E8 Inf.U and is an LF suspension to be administered subcutaneously into the...” NCT07199569 ↗ |
| Known as | MVA-BN Smallpox vaccine | “MVA-BN Smallpox vaccine” NCT04410874 ↗ |
| Modality | Vaccine | “MVA vaccines” PMID 23349878 ↗ Jan 2013 |
| Route | Intramuscular | “will be administered intramuscularly to Group F” NCT00082446 ↗ |