Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
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. Trial Registration This clinical trial was retrospectively registered on 16 January 2019 at Clinicaltrials.gov (NCT03806686)..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
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| Enthalten in: |
Infectious diseases and therapy - 12(2023), 6 vom: 11. Mai, Seite 1605-1624 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Choi, Yu Hwa [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
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| Anmerkungen: |
© The Author(s) 2023 |
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| doi: |
10.1007/s40121-023-00806-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
OLC2143994249 |
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| 245 | 1 | 0 | |a Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial |
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| 520 | |a 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. Trial Registration This clinical trial was retrospectively registered on 16 January 2019 at Clinicaltrials.gov (NCT03806686). | ||
| 650 | 4 | |a Tuberculosis | |
| 650 | 4 | |a Subunit vaccine | |
| 650 | 4 | |a GLA-SE | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Immunogenicity | |
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| 700 | 1 | |a Park, Kwang Joo |4 aut | |
| 700 | 1 | |a Choi, Jae Chol |4 aut | |
| 700 | 1 | |a Cho, Kwan Goo |4 aut | |
| 700 | 1 | |a Ko, Da Yeon |4 aut | |
| 700 | 1 | |a Ahn, Jun Ho |4 aut | |
| 700 | 1 | |a Lee, Boram |4 aut | |
| 700 | 1 | |a Ahn, Eunsol |4 aut | |
| 700 | 1 | |a Woo, Yun Ju |4 aut | |
| 700 | 1 | |a Jung, Kwangsoo |4 aut | |
| 700 | 1 | |a Kim, Nan Yul |4 aut | |
| 700 | 1 | |a Reese, Valerie A. |4 aut | |
| 700 | 1 | |a Larsen, Sasha E. |4 aut | |
| 700 | 1 | |a Baldwin, Susan L. |4 aut | |
| 700 | 1 | |a Reed, Steven G. |4 aut | |
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| 700 | 1 | |a Lee, Hyejon |0 (orcid)0000-0001-8207-537X |4 aut | |
| 700 | 1 | |a Cho, Sang-Nae |4 aut | |
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