Mary Wilson
Well-known member
Published 06 March 2023
DOI https://doi.org/10.1038/s41467-023-36789-2
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 &
Christopher B. Fox
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 < 0.05) and more antibody-secreting cells (p < 0.05). In this work, we show the thermostable ID93 + GLA-SE vaccine candidate is safe and immunogenic in healthy adults.
https://www.nature.com/articles/s41467-023-36789-2#citeas
DOI https://doi.org/10.1038/s41467-023-36789-2
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 &
Christopher B. Fox
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 < 0.05) and more antibody-secreting cells (p < 0.05). In this work, we show the thermostable ID93 + GLA-SE vaccine candidate is safe and immunogenic in healthy adults.
https://www.nature.com/articles/s41467-023-36789-2#citeas