Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults

Zachary K. Sagawa, Cristina Goman, Aude Frevol, Azra Blazevic, Janice Tennant, Bridget Fisher, Tracey Day, Stephen Jackson, Franck Lemiale, Leon Toussaint, Irene Kalisz, Joe Jiang, Lisa Ondrejcek, Raodoh Mohamath, Julie Vergara, Alan Lew, Anna Marie Beckmann, Corey Casper, Daniel F. Hoft and Christopher B. Fox ()
Additional contact information
Zachary K. Sagawa: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Cristina Goman: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Aude Frevol: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Azra Blazevic: Saint Louis University Center for Vaccine Development
Janice Tennant: Saint Louis University Center for Vaccine Development
Bridget Fisher: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Tracey Day: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Stephen Jackson: Advanced Bioscience Laboratories (ABL), Inc.
Franck Lemiale: Advanced Bioscience Laboratories (ABL), Inc.
Leon Toussaint: Advanced Bioscience Laboratories (ABL), Inc.
Irene Kalisz: Advanced Bioscience Laboratories (ABL), Inc.
Joe Jiang: DF/Net Research, Inc.
Lisa Ondrejcek: DF/Net Research, Inc.
Raodoh Mohamath: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Julie Vergara: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Alan Lew: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Anna Marie Beckmann: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Corey Casper: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)
Daniel F. Hoft: Saint Louis University Center for Vaccine Development
Christopher B. Fox: Access to Advanced Health Institute (formerly Infectious Disease Research Institute)

Nature Communications, 2023, vol. 14, issue 1, 1-13

Abstract: Abstract Adjuvant-containing subunit vaccines represent a promising approach for protection against tuberculosis (TB), but current candidates require refrigerated storage. Here we present results from a randomized, double-blinded Phase 1 clinical trial (NCT03722472) evaluating the safety, tolerability, and immunogenicity of a thermostable lyophilized single-vial presentation of the ID93 + GLA-SE vaccine candidate compared to the non-thermostable two-vial vaccine presentation in healthy adults. Participants were monitored for primary, secondary, and exploratory endpoints following intramuscular administration of two vaccine doses 56 days apart. Primary endpoints included local and systemic reactogenicity and adverse events. Secondary endpoints included antigen-specific antibody (IgG) and cellular immune responses (cytokine-producing peripheral blood mononuclear cells and T cells). Both vaccine presentations are safe and well tolerated and elicit robust antigen-specific serum antibody and Th1-type cellular immune responses. Compared to the non-thermostable presentation, the thermostable vaccine formulation generates greater serum antibody responses (p

Date: 2023
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DOI: 10.1038/s41467-023-36789-2

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