Last update 13 Dec 2024
Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)
Last update 13 Dec 2024
Overview
Basic Info
Drug Type Inactivated vaccine, Therapeutic vaccine |
Synonyms ID93 + GLA-SE, Tuberculosi, Tuberculosis vaccine adjuvanted + [5] |
Target- |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Gene Sequence
Sequence Code 9532112
Related
8
Clinical Trials associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants with Rifampicin-Susceptible Pulmonary TB
A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Explore the Immunogenicity of ID93+GLA-SE Vaccine in BCG-Vaccinated Healthy Adolescent
A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
100 Clinical Results associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)
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100 Translational Medicine associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)
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100 Patents (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)
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34
Literatures (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)01 Jun 2023Infectious diseases and therapy
Safety and Immunogenicity of the ID93 + GLA-SE Tuberculosis Vaccine in BCG-Vaccinated Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.
Article
Author: Kim, Nan Yul ; Park, Kwang Joo ; Woo, Yun Ju ; Coler, Rhea N ; Kang, Young Ae ; Larsen, Sasha E ; Cho, Sang-Nae ; Lee, Boram ; Choi, Yu Hwa ; Jung, Kwangsoo ; Cho, Kwan Goo ; Lee, Hyejon ; Reese, Valerie A ; Ahn, Jun Ho ; Choi, Jae Chol ; Reed, Steven G ; Ahn, Eunsol ; Ko, Da Yeon ; Baldwin, Susan L
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).
08 Feb 2022JCI insightQ1 · MEDICINE
Aerosol delivery, but not intramuscular injection, of adenovirus-vectored tuberculosis vaccine induces respiratory-mucosal immunity in humans
Q1 · MEDICINE
ArticleOA
Author: Kolb, Martin ; Cusack, Ruth P ; O'Byrne, Paul M ; Fritz, Dominik K ; Lichty, Brian D ; Xing, Zhou ; Aguirre, Emilio ; Thompson, Michael R ; Howie, Karen J ; Zganiacz, Anna ; Gauvreau, Gail M ; Smaill, Fiona ; Jeyanathan, Mangalakumari ; Medina, Maria Fe C ; Dvorkin-Gheva, Anna ; Silver, Richard F ; Afkhami, Sam ; Dolovich, Myrna B ; Satia, Imran
BackgroundAdenovirus-vectored (Ad-vectored) vaccines are typically administered via i.m. injection to humans and are incapable of inducing respiratory mucosal immunity. However, aerosol delivery of Ad-vectored vaccines remains poorly characterized, and its ability to induce mucosal immunity in humans is unknown. This phase Ib trial evaluated the safety and immunogenicity of human serotype-5 Ad-vectored tuberculosis (TB) vaccine (AdHu5Ag85A) delivered to humans via inhaled aerosol or i.m. injection.MethodsThirty-one healthy, previously BCG-vaccinated adults were enrolled. AdHu5Ag85A was administered by single-dose aerosol using Aeroneb Solo Nebulizer or by i.m. injection. The study consisted of the low-dose (LD) aerosol, high-dose (HD) aerosol, and i.m. groups. The adverse events were assessed at various times after vaccination. Immunogenicity data were collected from the peripheral blood and bronchoalveolar lavage samples at baseline, as well as at select time points after vaccination.ResultsThe nebulized aerosol droplets were < 5.39 μm in size. Both LD and HD of AdHu5Ag85A administered by aerosol inhalation and i.m. injection were safe and well tolerated. Both aerosol doses, particularly LD, but not i.m., vaccination markedly induced airway tissue-resident memory CD4+ and CD8+ T cells of polyfunctionality. While as expected, i.m. vaccination induced Ag85A-specific T cell responses in the blood, the LD aerosol vaccination also elicited such T cells in the blood. Furthermore, the LD aerosol vaccination induced persisting transcriptional changes in alveolar macrophages.ConclusionInhaled aerosol delivery of Ad-vectored vaccine is a safe and superior way to elicit respiratory mucosal immunity. This study warrants further development of aerosol vaccine strategies against respiratory pathogens, including TB and COVID-19.Trial registrationClinicalTrial.gov, NCT02337270.FundingThe Canadian Institutes for Health Research (CIHR) and the Natural Sciences and Engineering Research Council of Canada funded this work.
01 Apr 2021The Lancet. Respiratory medicineQ1 · MEDICINE
Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial
Q1 · MEDICINE
Article
Author: Cynthia Ontong ; Adam Penn-Nicholson ; Tom A Rolf ; Alessandro Companie ; Marcia Steyn ; Julie Vergara ; Gail Jacobs ; Carolyn Jones ; Andreas Diacon ; Gerhard Walzl ; Fan-Chi Hsu ; Aude Frevol ; Julia Noble ; Thomas J Scriba ; Ann Swarts ; Angelique Mouton ; Amaryl Van Schalkwyk ; Humphrey Mulenga ; Yolundi Cloete ; Yolandi Herselman ; Hadn Africa ; Julia Amsterdam ; Marwou de Kock ; Alana Keyser ; Steven G Reed ; Nelita Du Plessis ; Sandra Kruger ; Hendrik Geldenhuys ; Alessandro Sette ; Tim D Reid ; Erica Smit ; Sarah Albertson ; Nicole Bilek ; Justin Shenje ; Mark Hatherill ; Elma Van Rooyen ; Devona Hofmeester ; Andre G Loxton ; Andrew Fiore-Gartland ; Asma Toefy ; Elisabeth Filander ; Susan Rossouw ; Constance Schreuder ; Lebohang Makhethe ; Tracey A Day ; Jill Ashman ; Fajwa Opperman ; Elize van der Riet ; Stuart Kahn ; Linda-Gail Bekker ; Cecilia Lindestam Arlehamn ; Anna Marie Beckmann ; Nambitha Quaqua ; Friedrich Thienemann ; Ashley Veldsman ; Linda van der Merwe ; Eunice Sinandile ; Angelique Kany Kany Luabeya ; Yiwen Lu ; Rhea N Coler ; Zachary K Sagawa ; Sandra Goliath ; Simbarashe Mabwe ; Andrea Gutschmidt ; Michele Tameris ; Leya Hassanally ; Natasja Botes
BACKGROUND:
A therapeutic vaccine that prevents recurrent tuberculosis would be a major advance in the development of shorter treatment regimens. We aimed to assess the safety and immunogenicity of the ID93 + GLA-SE vaccine at various doses and injection schedules in patients with previously treated tuberculosis.
METHODS:
This randomised, double-blind, placebo-controlled, phase 2a trial was conducted at three clinical sites near Cape Town, South Africa. Patients were recruited at local clinics after receiving 4 months of tuberculosis treatment, and screened for eligibility after providing written informed consent. Participants were aged 18-60 years, BCG-vaccinated, HIV-uninfected, and diagnosed with drug-sensitive pulmonary tuberculosis. Eligible patients had completed standard treatment for pulmonary tuberculosis in the past 28 days. Participants were enrolled after completing standard treatment and randomly assigned sequentially to receive vaccine or placebo in three cohorts: 2 μg intramuscular ID93 + 2 μg GLA-SE on days 0 and 56 (cohort 1); 10 μg ID93 + 2 μg GLA-SE on days 0 and 56 (cohort 2); 2 μg ID93 + 5 μg GLA-SE on days 0 and 56 and placebo on day 28 (cohort 3); 2 μg ID93 + 5 μg GLA-SE on days 0, 28, and 56 (cohort 3); or placebo on days 0 and 56 (cohorts 1 and 2), with the placebo group for cohort 3 receiving an additional injection on day 28. Randomisation was in a ratio of 3:1 for ID93 + GLA-SE and saline placebo in cohorts 1 and 2, and in a ratio of 3:3:1 for (2 ×) ID93 + GLA-SE, (3 ×) ID93 + GLA-SE, and placebo in cohort 3. The primary outcomes were safety and immunogenicity (vaccine-specific antibody response and T-cell response). For the safety outcome, participants were observed for 30 min after each injection, injection site reactions and systemic adverse events were monitored until day 84, and serious adverse events and adverse events of special interest were monitored for 6 months after the last injection. Vaccine-specific antibody responses were measured by serum ELISA, and T-cell responses after stimulation with vaccine antigens were measured in cryopreserved peripheral blood mononuclear cells specimens using intracellular cytokine staining followed by flow cytometry. This study is registered with ClinicalTrials.gov, number NCT02465216.
FINDINGS:
Between June 17, 2015, and May 30, 2016, we assessed 177 patients for inclusion. 61 eligible patients were randomly assigned to receive: saline placebo (n=5) or (2 ×) 2 μg ID93 + 2 μg GLA-SE (n=15) on days 0 and 56 (cohort 1); saline placebo (n=2) or (2 ×) 10 μg ID93 + 2 μg GLA-SE (n=5) on days 0 and 56 (cohort 2); saline placebo (n=5) on days 0, 28 and 56, or 2 μg ID93 + 5 μg GLA-SE (n=15) on days 0 and 56 and placebo injection on day 28, or (3 ×) 2 μg ID93 + 5 μg GLA-SE (n=14) on days 0, 28, and 56 (cohort 3). ID93 + GLA-SE induced robust and durable antibody responses and specific, polyfunctional CD4 T-cell responses to vaccine antigens. Two injections of the 2 μg ID93 + 5 μg GLA-SE dose induced antigen-specific IgG and CD4 T-cell responses that were significantly higher than those with placebo and persisted for the 6-month study duration. Mild to moderate injection site pain was reported after vaccination across all dose combinations, and induration and erythema in patients given 2 μg ID93 + 5 μg GLA-SE in two or three doses. One participant had grade 3 erythema and induration at the injection site. No vaccine-related serious adverse events were observed.
INTERPRETATION:
Vaccination with ID93 + GLA-SE was safe and immunogenic for all tested regimens. These data support further evaluation of ID93 + GLA-SE in therapeutic vaccination strategies to improve tuberculosis treatment outcomes.
FUNDING:
Wellcome Trust (102028/Z/13/Z).
2
News (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)24 Mar 2023
Phase 2VaccinePhase 3Phase 1Clinical Result
06 Mar 2023
Clinical ResultVaccinePhase 1Immunotherapy
100 Deals associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)
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R&D Status
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pulmonary Tuberculosis | Phase 2 | - | 31 May 2025 | |
| Tuberculosis | Phase 2 | KR | 26 May 2018 |
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Clinical Result
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Phase 1 | 48 | GLA+ID93 (Single-vial Presentation ID93 + GLA-SE) | pqywiytugm(bzoosvgufy) = rfpwhxsymx ubijjhsofr (xofxrhlddh, kvhipmtumk - wykxbbuwrf) View more | - | 01 Jun 2023 | ||
GLA (Two-vial Presentation ID93 + GLA-SE) | pqywiytugm(bzoosvgufy) = kreqmwlwno ubijjhsofr (xofxrhlddh, zocftwcedt - cvcjniqkiq) View more |
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