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Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

 Yu Hwa Choi  ;  Young Ae Kang  ;  Kwang Joo Park  ;  Jae Chol Choi  ;  Kwan Goo Cho  ;  Da Yeon Ko  ;  Jun Ho Ahn  ;  Boram Lee  ;  Eunsol Ahn  ;  Yun Ju Woo  ;  Kwangsoo Jung  ;  Nan Yul Kim  ;  Valerie A Reese  ;  Sasha E Larsen  ;  Susan L Baldwin  ;  Steven G Reed  ;  Rhea N Coler  ;  Hyejon Lee  ;  Sang-Nae Cho 
 INFECTIOUS DISEASES AND THERAPY, Vol.12(6) : 1605-1624, 2023-06 
Journal Title
Issue Date
GLA-SE ; Immunogenicity ; Safety ; Subunit vaccine ; Tuberculosis
Introduction: This randomized, double-blind, placebo-controlled, phase 2a trial was conducted to evaluate the safety and immunogenicity of the ID93 + glucopyranosyl lipid adjuvant (GLA)-stable emulsion (SE) vaccine in human immunodeficiency virus (HIV)-negative, previously Bacillus Calmette-Guérin (BCG)-vaccinated, and QuantiFERON-TB-negative healthy adults in South Korea.

Methods: Adults (n = 107) with no signs or symptoms of tuberculosis were randomly assigned to receive three intramuscular injections of 2 μg ID93 + 5 μg GLA-SE, 10 μg ID93 + 5 μg GLA-SE, or 0.9% normal saline placebo on days 0, 28, and 56. For safety assessment, data on solicited adverse events (AEs), unsolicited AEs, serious AEs (SAEs), and special interest AEs were collected. Antigen-specific antibody responses were measured using serum enzyme-linked immunosorbent assay. T-cell immune responses were measured using enzyme-linked immunospot and intracellular cytokine staining.

Results: No SAEs, deaths, or AEs leading to treatment discontinuation were found. The solicited local and systemic AEs observed were consistent with those previously reported. Compared with adults administered with the placebo, those administered with three intramuscular vaccine injections exhibited significantly higher antigen-specific antibody levels and Type 1 T-helper cellular immune responses.

Conclusion: The ID93 + GLA-SE vaccine induced antigen-specific cellular and humoral immune responses, with an acceptable safety profile in previously healthy, BCG-vaccinated, Mycobacterium tuberculosis-uninfected adult healthcare workers.
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1. College of Medicine (의과대학) > Research Institute (부설연구소) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Young Ae(강영애) ORCID logo https://orcid.org/0000-0002-7783-5271
Lee, Hyejon(이혜존) ORCID logo https://orcid.org/0000-0001-8207-537X
Cho, Sang Nae(조상래)
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