Drugs / IC31
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02496897 | Jul 2015 → Oct 2017 | hepatitis B virus infection | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02375698 | Nov 2014 → Jun 2016 | tuberculosis | Aeras | Completed | No outcome recorded |
| Phase 1 | NCT02420444 | Jan 2011 → May 2012 | tuberculosis | Aeras | Completed | No outcome recorded |
| Phase 1 | NCT01049282 | Dec 2008 → Apr 2010 | tuberculosis | Statens Serum Institut | Completed | No outcome recorded |
| Phase 1 | NCT02074956 | May 2008 → Oct 2009 | tuberculosis | Aeras | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01861730 | Jul 2013 → Dec 2017 | tuberculosis | Aeras | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03265977 | Jun 2018 → Apr 2021 | tuberculosis | Aeras | Withdrawn | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT00929396 Background | Sep 2007 → Jun 2009 | tuberculosis | Statens Serum Institut | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2014-12-10 | Valneva Austria GmbH | Results Valneva Announces Publication of First Phase II Data of Tuberculosis Vaccine Candidate Formulated with IC31® Adjuvant: Clinical Trial in HIV-infected Adults Showed Good Safety and Immunogenicity valneva.com ↗
Valneva SE (“Valneva”) announced today that the Statens Serum Institut ’s (SSI) novel Tuberculosis (TB) vaccine candidate H1/IC31 ® formulated with Valneva’s proprietary adjuvant IC31 ® showed good safety and immunogenicity in Phase II clinical trial in HIV-infected adults. |
All press releases naming this drug 4 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IC31 | “In the present study, we monitored safety and IFN-γ responses in healthy BCG-vaccinated and prior or latently TB-infected individuals receiving a novel vaccine composed of the...” PMID 21256189 ↗ Jan 20117“AERAS-404 is comprised of the H4 antigen, a fusion protein of Mycobacterium tuberculosis antigens 85B and TB10.4; and IC31 adjuvant, a combination of a leucine-rich peptide and...” NCT02074956 ↗ “AERAS-404 50/500 was a fixed dose combination of H4 50 mcg and IC31 500 nmol (KLK equivalent).” NCT02420444 ↗ “IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57.” NCT02496897 ↗ “AERAS-404 has two components: the H4 antigen and the IC31 adjuvant.” NCT01861730 ↗ |
| Modality | Other / unclassified | “IC31 adjuvant, a combination of a leucine-rich peptide and a synthetic oligonucleotide” NCT02074956 ↗ |
| Route | Other | “o,5 mL suspension for injection x 2 with 2 months interval” NCT00929396 ↗ |