H56:IC31

also known as AERAS-456

Developed for: latent tuberculosis infection · tuberculosis · pulmonary tuberculosis
Investigated by: Statens Serum Institut · Aeras · Anne Margarita Dyrhol Riise · European and Developing Countries Clinical Trials Partnership (EDCTP) · HIV Vaccine Trials Network · Haukeland University Hospital
+9 more
· International AIDS Vaccine Initiative · National Institute for Medical Research, Tanzania · Ospedale San Raffaele · Sanofi Pasteur, a Sanofi Company · South African Tuberculosis Vaccine Initiative · TASK Applied Science · The Aurum Institute NPC · University of Cape Town Lung Institute · University of Oslo

2012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 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	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 21 trial · 1 missed
Phase 2	NCT03512249	Jan 2019 → Mar 2023	pulmonary tuberculosis	International AIDS Vaccine Initiative	Completed	Missed primary

Every value below carries the sentence it was read from. 6 sources stand behind the page.

Field	Value	Cited text
Known as	H56:IC31	“H56:IC31, an experimental TB vaccine comprising Ag85B, ESAT-6, and Rv2660c” PMID 30092143 ↗ Jan 2019 4 NCT02378207 ↗ NCT03512249 ↗ NCT01967134 ↗ 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 ↗
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 ↗