Drugs / HEPLISAV
last change Dec 2017 re-read 2 minutes ago

HEPLISAV

also known as HBsAg-1018

Vaccine

Developed for
hepatitis B virus infection
Investigated by
Dynavax Technologies Corporation · Baylor Research Institute

Trials 6 · a red edge is where a trial was stopped

200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01999699 Nov 2013 → Feb 2015 hepatitis B virus infection Dynavax Technologies Corporation Completed No outcome recorded
Phase 21 trial
Phase 2 NCT00511095 Jun → Oct 2007 hepatitis B virus infection Dynavax Technologies Corporation Completed No outcome recorded
Phase 34 trials
Phase 3 NCT02117934 Apr 2014 → Oct 2015 Dynavax Technologies Corporation Completed No outcome recorded
Phase 3 NCT01195246 Dec 2010 → Feb 2012 end stage renal failure Dynavax Technologies Corporation Completed No outcome recorded
Phase 3 NCT01005407 Feb 2010 → Jan 2011 Dynavax Technologies Corporation Completed No outcome recorded
Phase 3 NCT00435812 Dec 2006 → Feb 2008 hepatitis B virus infection Dynavax Technologies Corporation Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as HEPLISAV “new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™” NCT00511095
6

NCT00435812

NCT01005407

NCT01195246

NCT00511095

NCT02117934

NCT01999699

Known as HBsAg-1018 “Phase 3 observer-blinded, randomized (2:1 HBsAg-1018 [HEPLISAV-B™]:HBsAg-Eng [Engerix-B®]), active-controlled trial” PMID 29289383 Dec 2017
Modality Vaccine “new investigational hepatitis B virus vaccine, HEPLISAV™” NCT00435812
Route Intramuscular Intramuscular (IM) injections on Week 0, Week 4; placebo (saline) injection at Week 24” NCT00435812