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Immunogenicity and Protective Efficacy of the DAR-901 Booster Vaccine in a Murine Model of Tuberculosis.

Immunogenicity and Protective Efficacy of the DAR-901 Booster Vaccine in a Murine Model of Tuberculosis.
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Lahey T, Laddy D, Hill K, Schaeffer J, Hogg A, Keeble J, Dagg B, Ho MM, Arbeit RD, von Reyn CF,


Lahey T, Laddy D, Hill K, Schaeffer J, Hogg A, Keeble J, Dagg B, Ho MM, Arbeit RD, von Reyn CF, (click to view)

Lahey T, Laddy D, Hill K, Schaeffer J, Hogg A, Keeble J, Dagg B, Ho MM, Arbeit RD, von Reyn CF,

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PloS one 2016 12 2011(12) e0168521 doi 10.1371/journal.pone.0168521

Abstract
BACKGROUND
The development of a novel tuberculosis vaccine is a leading global health priority. SRL172, an inactivated, whole-cell mycobacterial vaccine, was safe, immunogenic and reduced the incidence of culture-confirmed tuberculosis in a phase III trial in HIV-infected and BCG immunized adults in Tanzania. Here we describe the immunogenicity and protective efficacy of DAR-901, a booster vaccine against tuberculosis manufactured from the same seed strain using a new scalable method.

METHODS
We evaluated IFN-γ responses by ELISpot and antibody responses by enzyme linked immunosorbent assay in C57BL/6 and BALB/c mice after three doses of DAR-901. In an aerosol challenge model, we evaluated the protective efficacy of the DAR-901 booster in C57BL/6 mice primed with BCG and boosted with two doses of DAR-901 at 4 dosage levels in comparison with homologous BCG boost.

RESULTS
DAR-901 vaccination elicited IFN-γ responses to mycobacterial antigen preparations derived from both DAR-901 and Mycobacterium tuberculosis. DAR-901 immunization enhanced antibody responses to DAR-901 but not Mycobacterium tuberculosis lysate or purified protein derivative. Among animals primed with BCG, boosting with DAR-901 at 1 mg provided greater protection against aerosol challenge than a homologous BCG boost (lungs P = 0.036, spleen P = 0.028).

CONCLUSIONS
DAR-901 induces cellular and humoral immunity and boosts protection from M. tuberculosis compared to a homologous BCG boost.

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