drugset
Drugs / H56:IC31
last change Mar 2023 re-read 2 minutes ago

H56:IC31

also known as H56 · AERAS-456 · H56 antigen

Vaccine

Developed for
tuberculosis · latent tuberculosis infection · pulmonary tuberculosis
Investigated by
Statens Serum Institut · Aeras · National Institute for Medical Research, Tanzania · South African Tuberculosis Vaccine Initiative · Anne Margarita Dyrhol Riise · Aurum Institute
+13 more · European and Developing Countries Clinical Trials Partnership (EDCTP) · HIV Vaccine Trials Network · Haukeland University Hospital · International AIDS Vaccine Initiative · Oslo University Hospital · Ospedale San Raffaele · Sanofi Pasteur, a Sanofi Company · TASK Applied Science · The Aurum Institute NPC · University of Bergen · University of Cape Town Lung Institute · University of Copenhagen · University of Oslo

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

today NCT03512249 · Ph 2 NCT03265977 · Ph 2 NCT02503839 · Ph 1 NCT02378207 · Ph 1 NCT02375698 · Ph 1 NCT01865487 · Ph 1/2 NCT01967134 · Ph 1
2012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT02503839 Nov 2015 → Sep 2019 tuberculosis Anne Margarita Dyrhol Riise Completed No outcome recorded
Phase 1 NCT02378207 May 2015 → Oct 2016 tuberculosis Aeras Completed No outcome recorded
Phase 1 NCT02375698 Nov 2014 → Jun 2016 tuberculosis Aeras Completed No outcome recorded
Phase 1 NCT01967134 Nov 2011 → Dec 2012 latent tuberculosis infection Aeras Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01865487 Aug 2013 → Aug 2015 latent tuberculosis infection Aeras Completed No outcome recorded
Phase 22 trials
Phase 2 NCT03512249 Jan 2019 → Mar 2023 pulmonary tuberculosis International AIDS Vaccine Initiative Completed No outcome recorded
Phase 2 NCT03265977 Jun 2018 → Apr 2021 tuberculosis Aeras Withdrawn No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as H56:IC31 “H56:IC31, an experimental TB vaccine comprising Ag85B, ESAT-6, and Rv2660c” PMID 30092143 ↗ Jan 2019
4

NCT01967134 ↗

NCT03512249 ↗

NCT02378207 ↗

NCT02503839 ↗
Known as AERAS-456 “The investigational product is H56:IC31 (AERAS-456) at a dose of 15 ug of H56 antigen with IC31 500 nmol KLK (15/500), and a dose of 50 ug of H56 antigen with IC31 500 nmol KLK...” NCT01967134 ↗
Known as H56 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03265977 ↗
1

NCT02375698 ↗
Known as H56 antigen “H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).” NCT02375698 ↗
Modality Vaccine “H56:IC31, an experimental TB vaccine comprising Ag85B, ESAT-6, and Rv2660c” PMID 30092143 ↗ Jan 2019
Route Intramuscular “The vaccine is administered by intramuscular (IM) injection.” NCT01865487 ↗