smallpox vaccine, tissue culture adapted jennerian
Trade name: ACAM2000
Vaccineapproved
Approved
Aug 31, 2007
ACAM2000 is a smallpox vaccine and an mpox vaccine manufactured by Emergent Biosolutions. It provides protection against smallpox for people determined to be at high risk for smallpox infection. ACAM2000 is a live replicating vaccinia virus vaccine. — Wikipedia
Clinical trial activity
7 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
3
Phase 3
2
Phase 4
2
Earliest trial started Mar 1, 2002 (NCT00042094)
Timeline
2000s
- Jan 1, 2002
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Aug 31, 2007
Earliest FDA Approval
- Sep 4, 2007
Emergent BioSolutions — First NDA Organization
- Sep 4, 2007
Emergent BioSolutions — NDA Organization
2010s
- Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Variola virusImmunity, active
Variola virus immunity, active
Approval history
- approvedAug 31, 2007
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaACAM2000 ↗
Also known as
- acam2000
- acam2000
- cell-cultured smallpox vaccine
- smallpox vaccine, tissue culture adapted jennerian
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05846243 | Phase 2/Phase 3 (Phase 3) | Oct 1, 2021 | Government of Russia |
| NCT02443623 | Phase 4 | Sep 1, 2015 | Cangene |
| NCT01913353 | Phase 3 | Mar 1, 2015 | Bavarian Nordic, United States Army |
| NCT01158157 | Phase 4 | Aug 1, 2010 | Cangene, Centers for Disease Control and Prevention (CDC) |
| NCT00053495 | Phase 2 | Jan 1, 2003 | Sanofi |
| NCT00053482 | Phase 2 | Jan 1, 2003 | Sanofi |
| NCT00042094 | Phase 1 | Mar 1, 2002 | DynPort Vaccine Company LLC |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cangene | For profit | 2 | 2 | 1 | 2010 |
| Sanofi | For profit | 2 | 2 | 1 | 2003 |
| Bavarian Nordic | For profit | 1 | 1 | 1 | 2015 |
| Centers for Disease Control and Prevention (CDC) | Government | 1 | 0 | 1 | 2010 |
| DynPort Vaccine Company LLC | For profit | 1 | 1 | 1 | 2002 |
| Government of Russia | Government | 1 | 1 | 1 | 2021 |
| United States Army | Government | 1 | 0 | 1 | 2015 |
7 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA | Sep 4, 2007 |