cholera vaccine
Trade name: Vaxchora
Approved
Jun 10, 2016
A cholera vaccine is a vaccine that is effective at reducing the risk of contracting cholera. The recommended cholera vaccines are administered orally to elicit local immune responses in the gut, where the intestinal cells produce antibodies against Vibrio cholerae, the bacteria responsible for the illness. This immune response was poorly achieved with the injectable vaccines that were used until the 1970s. The first effective oral cholera vaccine was Dukoral, developed in Sweden in the 1980s. For the first six months after vaccination it provides about 85% protection, which decreases to approximately 60% during the first two years. When enough of the population is immunized, it may protect those who have not been immunized thereby increasing the total protective impact to more than 90 %. — Wikipedia
Clinical trial activity
25 trials · 22 clinical orgs · 1 marketing orgs
Earliest trial started Jan 1, 2010 (NCT01042951)
Timeline
2010s
- Jan 1, 2010
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2011
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2012
Earliest Phase 3 Sponsor(trial)
- Jun 10, 2016
Emergent BioSolutions — Earliest FDA Approval
- Jun 10, 2016
Emergent BioSolutions — NDA Secondary Org
- Jun 10, 2016
Emergent BioSolutions — NDA Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Biological vaccine - induces immune response
- Vibrio choleraeImmunity, active
Vibrio cholerae immunity, active
Approval history
- approvedJun 10, 2016
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaCholera vaccine ↗
- ChEMBLCHEMBL2108939 ↗
Also known as
- cholera, live attenuated
- cholera vaccine
- cholera vaccine
- cholera vaccine
- pxvx0200
- shanchol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07107516 | Phase 1 | Oct 1, 2025 | Centre for Infectious Disease Research in Zambia (CIDRZ) |
| NCT05657782 | Phase 1 | Dec 12, 2022 | Harvard University |
| NCT05559983 | Phase 1 | Nov 30, 2022 | EuBiologics Co.,Ltd, Harvard University, International Vaccine Institute |
| NCT03705585 | Phase 4 | Nov 5, 2018 | University of Maryland |
| NCT03724357 | Phase 4 | Nov 4, 2018 | University of Maryland |
| NCT03998449 | N/A | Aug 30, 2017 | Medical University of Gdansk, Medical University of Warsaw |
| NCT03251495 | Phase 2 | Aug 29, 2017 | Emory University |
| NCT03220737 | Phase 4 | Jul 21, 2017 | PaxVax, Inc. |
| NCT02924246 | N/A | Aug 1, 2016 | FrieslandCampina, NIZO Food Research |
| NCT02502331 | Phase 3 | Mar 1, 2016 | EuBiologics Co.,Ltd, International Vaccine Institute |
| NCT02434822 | Phase 3 | Apr 1, 2015 | Sanofi, Sanofi-Aventis |
| NCT02145377 | Phase 2 | Jul 1, 2014 | Centre pour le developpement des vaccines, Mali, PaxVax, Inc., Shantha Biotechnics Limited, University of Maryland |
| NCT02238548 | N/A | Jul 1, 2014 | FrieslandCampina, NIZO Food Research |
| NCT02164110 | Phase 3 | May 1, 2014 | De La Salle University, EuBiologics Co.,Ltd, Instituto Universitario IVI |
| NCT02094586 | Phase 3 | May 1, 2014 | PaxVax, Inc. |
| NCT02100631 | Phase 3 | May 1, 2014 | PaxVax, Inc. |
| NCT01949675 | Phase 4 | Mar 1, 2014 | Sanofi, Sanofi-Aventis |
| NCT01895855 | Phase 3 | Sep 1, 2013 | PaxVax, Inc. |
| NCT01579448 | Phase 4 | Dec 1, 2012 | Indian Council of Medical Research, International Vaccine Institute, National Institute of Cholera and Enteric Diseases, Kolkata, India |
| NCT02027207 | Phase 3 | Dec 1, 2012 | Government of Bangladesh, International Center for Diarrheal Disease Research, International Vaccine Institute |
Organizations
Research & Development (22)
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Emergent BioSolutions | For profit | NDA2 | Jun 10, 2016 |
| Emergent BioSolutions | For profit | NDA | Jun 10, 2016 |