Drugs / IC31

Trials 7 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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Phase 2 NCT03265977 Jun 2018 → Apr 2021 tuberculosis Aeras Withdrawn No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT00929396 Background Sep 2007 → Jun 2009 tuberculosis Statens Serum Institut Completed No outcome recorded

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited 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 2011
7

“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

NCT03265977

NCT01049282

NCT02375698

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