Safety and immunogenicity of an inactivated whole cell tuberculosis vaccine booster in adults primed with BCG: A randomized, controlled trial of DAR-901

PloS One
C Fordham von ReynR D Waddell

Abstract

Development of a tuberculosis vaccine to boost BCG is a major international health priority. SRL172, an inactivated whole cell booster derived from a non-tuberculous mycobacterium, is the only new vaccine against tuberculosis to have demonstrated efficacy in a Phase 3 trial. In the present study we sought to determine if a three-dose series of DAR-901 manufactured from the SRL172 master cell bank by a new, scalable method was safe and immunogenic. We performed a single site, randomized, double-blind, controlled, Phase 1 dose escalation trial of DAR-901 at Dartmouth-Hitchcock Medical Center in the United States. Healthy adult subjects age 18-65 with prior BCG immunization and a negative interferon-gamma release assay (IGRA) were enrolled in cohorts of 16 subjects and randomized to three injections of DAR-901 (n = 10 per cohort), or saline placebo (n = 3 per cohort), or two injections of saline followed by an injection of BCG (n = 3 per cohort; 1-8 x 106 CFU). Three successive cohorts were enrolled representing DAR-901 at 0.1, 0.3, and 1 mg per dose. Randomization was performed centrally and treatments were masked from staff and volunteers. Subsequent open label cohorts of HIV-negative/IGRA-positive subjects (n = 5) and HIV-posit...Continue Reading

Associated Clinical Trials

References

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Aug 12, 2009·Proceedings of the National Academy of Sciences of the United States of America·Laith J Abu-RaddadM Elizabeth Halloran
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Oct 8, 2014·Proceedings of the National Academy of Sciences of the United States of America·Gwenan M KnightRichard G White
Mar 15, 2016·Vaccine·Thomas G EvansJelle Thole

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Citations

Aug 7, 2018·Current Opinion in HIV and AIDS·Elisa NemesMark Hatherill
Mar 21, 2019·Expert Review of Vaccines·Ann M Ginsberg
May 28, 2019·Immunology and Cell Biology·Claudio Counoupas, James A Triccas
Dec 1, 2019·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·Stefan H E Kaufmann
Feb 16, 2020·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·Junli LiChuan Qin
Mar 15, 2018·Frontiers in Immunology·Mariateresa CoppolaAnnemieke Geluk
Dec 20, 2019·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·Kai Ling ChinArmando Acosta
Feb 23, 2020·Frontiers in Microbiology·Mark HatherillThomas R Hawn
Aug 30, 2020·Disease Models & Mechanisms·Anni K SaralahtiMika Rämet
Mar 27, 2021·Human Vaccines & Immunotherapeutics·Thomas ChoVishwanath Venketaraman
Feb 6, 2020·The Lancet Infectious Diseases·Lewis K SchragerOle F Olesen
Apr 4, 2021·Vaccine·Samantha BannisterNigel Curtis

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Methods Mentioned

BETA
ELISA
pregnancy test
density gradient separation
PCR

Clinical Trials Mentioned

NCT02063555

Software Mentioned

GraphPad Prism

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