Last update 21 Nov 2024

Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Inactivated vaccine, Therapeutic vaccine

Synonyms

ID93 + GLA-SE, Tuberculosi, Tuberculosis vaccine adjuvanted

+ [5]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Pulmonary Tuberculosis

Inactive Indication-

Originator Organization

Infectious Disease Research Institute

Active Organization

Aeras Technologies LLC

Infectious Disease Research InstituteNational Institute of Allergy & Infectious Diseases

Inactive Organization

Quratis, Inc.Startup

Aeras Global TB Vaccine Foundation

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 9532112

Clinical Trials associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

NCT06205589 / Not yet recruitingPhase 2IIT

A Phase 2a/2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB

This study is being done to test an experimental study vaccine compared to a placebo. The experimental study vaccine is called ID93 + GLA-SE. ID93 + GLA-SE has been used in humans in research but has not been approved for use in medical care. This study will be the first to test ID93 + GLA-SE in people living with HIV (PLWH). The injections during the study will be given to different groups of participants while they are using standard TB treatment. One of the research questions is to understand the differences in immune system responses depending on the timing of giving the injections after people begin taking standard TB treatment. Researchers also want to continue to look at whether the study vaccine is safe when tested in a larger group of people, and if getting the study vaccine in addition to standard TB treatment can help to lower the number of poor TB outcomes that people might have.

Start Date15 Oct 2024

Sponsor / Collaborator

The Aids Clinical Trials Group

[+1]

NCT03806699 / Unknown statusPhase 1

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

The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety and immunogenicity tests. The study hypothesis is that the vaccine is safe and immunogenic in this study population.

Start Date02 Apr 2019

Sponsor / Collaborator

Quratis, Inc.Startup

NCT03722472 / CompletedPhase 1IIT

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

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

Start Date02 Oct 2018

Sponsor / Collaborator

Access To Advanced Health Institute

[+2]

100 Clinical Results associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

100 Translational Medicine associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

100 Patents (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

Literatures (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

01 Jun 2023·Infectious 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: Cho, Sang-Nae ; Choi, Yu Hwa ; Lee, Boram ; Larsen, Sasha E ; Reese, Valerie A ; Cho, Kwan Goo ; Choi, Jae Chol ; Baldwin, Susan L ; Woo, Yun Ju ; Coler, Rhea N ; Ahn, Eunsol ; Kim, Nan Yul ; Lee, Hyejon ; Kang, Young Ae ; Jung, Kwangsoo ; Park, Kwang Joo ; Reed, Steven G ; Ahn, Jun Ho ; Ko, Da Yeon

INTRODUCTIONThis 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.METHODSAdults (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.RESULTSNo 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.CONCLUSIONThe 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 REGISTRATIONThis clinical trial was retrospectively registered on 16 January 2019 at Clinicaltrials.gov (NCT03806686).

08 Feb 2022·JCI InsightQ1 · MEDICINE

Aerosol delivery, but not intramuscular injection, of adenovirus-vectored tuberculosis vaccine induces respiratory-mucosal immunity in humans

Q1 · MEDICINE

ArticleOA

Author: Zganiacz, Anna ; Thompson, Michael R ; Dolovich, Myrna B ; Fritz, Dominik K ; Gauvreau, Gail M ; Medina, Maria Fe C ; Afkhami, Sam ; Lichty, Brian D ; Dvorkin-Gheva, Anna ; O'Byrne, Paul M ; Xing, Zhou ; Jeyanathan, Mangalakumari ; Satia, Imran ; Cusack, Ruth P ; Smaill, Fiona ; Aguirre, Emilio ; Kolb, Martin ; Howie, Karen J ; Silver, Richard F

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 2021·The 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: Tracey A Day ; Elma Van Rooyen ; Lebohang Makhethe ; Tom A Rolf ; Tim D Reid ; Alessandro Sette ; Linda van der Merwe ; Asma Toefy ; Thomas J Scriba ; Fan-Chi Hsu ; Natasja Botes ; Yolandi Herselman ; Andreas Diacon ; Jill Ashman ; Gerhard Walzl ; Yolundi Cloete ; Devona Hofmeester ; Alessandro Companie ; Elisabeth Filander ; Julia Noble ; Hendrik Geldenhuys ; Mark Hatherill ; Stuart Kahn ; Steven G Reed ; Eunice Sinandile ; Carolyn Jones ; Nicole Bilek ; Cynthia Ontong ; Michele Tameris ; Andre G Loxton ; Cecilia Lindestam Arlehamn ; Marwou de Kock ; Friedrich Thienemann ; Andrea Gutschmidt ; Andrew Fiore-Gartland ; Marcia Steyn ; Sarah Albertson ; Sandra Goliath ; Gail Jacobs ; Julia Amsterdam ; Leya Hassanally ; Susan Rossouw ; Julie Vergara ; Adam Penn-Nicholson ; Zachary K Sagawa ; Justin Shenje ; Ashley Veldsman ; Elize van der Riet ; Anna Marie Beckmann ; Nelita Du Plessis ; Sandra Kruger ; Humphrey Mulenga ; Alana Keyser ; Linda-Gail Bekker ; Simbarashe Mabwe ; Angelique Kany Kany Luabeya ; Rhea N Coler ; Fajwa Opperman ; Amaryl Van Schalkwyk ; Angelique Mouton ; Erica Smit ; Nambitha Quaqua ; Constance Schreuder ; Aude Frevol ; Hadn Africa ; Ann Swarts ; Yiwen Lu

BACKGROUNDA 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.METHODSThis 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.FINDINGSBetween 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.INTERPRETATIONVaccination 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.FUNDINGWellcome Trust (102028/Z/13/Z).

News (Medical) associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

24 Mar 2023

·www.pharmaceutical-technology.com

Pharma Fix: The quest for the next tuberculosis vaccine

Credit: Shutterstock/ Helena Nechaeva Since the first human administration of the Bacillus Calmette-Guérin vaccine in 1921, no one has been able to successfully follow the vaccine’s path to become the next approved vaccine to tackle tuberculosis (TB). However, as the TB-related death toll remains high, the global need for another vaccine is steadily rising. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. TB is caused by the bacillus Mycobacterium tuberculosis and is transmitted when infected individuals expel bacteria into the air (e.g., by coughing). According to the World Health Organization (WHO), despite a reduction in TB cases during the Covid-19 pandemic, the incidence has risen again with 6.4 million new cases reported worldwide. Researchers expect TB to soon return to its pre-2020 position as the deadliest infectious disease globally. In light of World TB day on March 24, the field hopes to overcome some major barriers to the drug development landscape. Unfortunately, lack of funding and resources remain an obstacle within the TB field for developing new vaccines. The BCG vaccine is a live-attenuated virus vaccine. This vaccine is also being used in cancer therapies, studied as a Covid-19 prophylactic and is also being considered as a vaccine for Alzheimer’s . However, the vaccine is less effective in those who already have viral antibodies present in their blood, leaving out a large proportion of people. The vaccine also only has an efficacy of 22%.“When children reach adolescence and adult age group, [the BCG vaccine] really does not have an impact on TB disease. Thus, new vaccine approaches are needed,” says Christopher Fox, PhD, an associate professor of Global Health at the University of Washington, Seattle. This is important as TB is mostly spread by adults. Despite the dearth of options, researchers are cautiously optimistic about the having new vaccines in the pipeline. Helen McShane, PhD, a professor of vaccinology at the University of Oxford, says, “Twenty-three years ago, there were no new TB vaccines being tested in clinical trials. We now have 12 vaccines being tested in clinical trials at different stages of development.” New Developments for TB In a recent Phase I clinical trial (NCT03722472), researchers have been able to test the first thermostable TB vaccine in patients. In this trial, patients were given a thermostable version of the vaccine or a non-thermostable vaccine in two treatment regimens. The results showed that participants’ antibody responses remained elevated through six months after the last vaccination in both regimens. The ID93 vaccine is being developed by the Infectious Disease Research Institute (IDRI). The trial, led by IDRI in collaboration with the National Institutes of Health (NIH), investigated a thermostable formulation of the previously tested ID93 + GLA-SEDr adjuvant subunit vaccine. The results showed that participants’ antibody responses remained elevated through six months after the last vaccination for the thermostable version of the vaccine and a non-thermostable vaccine formulation. Fox, the principal scientist behind the trial, says this is an important development in TB vaccine research as the current BCG vaccine must be refrigerated. He explains that this new vaccine could be stored at 37 degree s Celsius for up to three months and may allow easier vaccine storage in more rural locations with a high prevalence of TB. Fox says adjuvant protein subunit vaccines can be a safer approach compared to live attenuated virus vaccines as there is a minimized risk of developing side effects. Using an adjuvant with an antigen can give specific tailored and potent immune responses, he adds. “There are a handful of vaccine candidates now that are using this approach and marching towards that efficacy testing stage in Phase II trials,” says Fox. The National Institutes of Health (NIH) is sponsoring a Phase II trial (trial ID?) of the ID93 + GLA-SEDr adjuvant subunit vaccine in South Africa. Copenhagen-based Statens Serum institut is also developing an adjuvant subunit vaccine called SSIH-56IC31 for the prevention of TB. McShane predicts the new pipeline vaccines could also address the issue of drug-resistance in TB. “We expect that all the [investigational] vaccines will work as well against drug resistant strains as they will against drug sensitive strains”. The Bill and Melinda Gates Medical Research Institute is also sponsoring an extensive, 26,000 participant-Phase III trial studying M72 (AS01E) , a protein adjuvant vaccine. Initially, GSK was studying the M72 TB vaccine but stopped funding the development after a successful Phase IIb study. News on this Phase III trial could be released in the next few months, says Dr. Alex Schmidt, Head of Vaccine Development at the Bill and Melinda Gates Medical Research Institute (MRI). The Phase IIb (NCT01755598) study found the vaccine to be 54% effective, making it a landmark in the field. However, McShane urges for the field not to become complacent. “We should not forget that we would not have accepted the Covid-19 vaccine that was only 50% effective. The Covid vaccines that we have are more than 90% effective, so it’s fantastic news… but we should not stop there,” she says. According to GlobalData, there are six TB vaccines in Phase III clinical trials right now. The Gamaleya Federal Research Center of Epidemiology and Microbiology is developing a protein subunit vaccine called GamTBvac for respiratory TB. GC Biopharma is also running a Phase III trial for its live-attenuated vaccine GC-3107A to replace BCG. Furthermore, the Serum Institute of India is also developing its own live-attenuated vaccine to replace BCG for infants, that can also be used by adults. GlobalData is the parent company of Pharmaceutical Technology. Stagnation in TB research Until approximately two decades ago, the field of TB vaccine development was stagnated due to the complexity of the virus and a lack of interest and funding. “As opposed to most viruses which often have 10 or 15 genes, MTB has 3,500 or so and we don’t understand the virulence factors. We also don’t understand why when 20 people are infected with MTB, only one gets ill and that’s a huge problem,” says Schmidt. Dr. Keertan Dheda, a professor of Mycobacteriology and Global Health at the University of Cape Town says, “We don’t know what biomarker identifies with successful immunity in TB…That has been a real challenge for TB vaccine development for decades now and we still don’t have a good idea”. The complexity of the virus and these unknown factors can also pose some challenges for clinical trials as larger patient cohorts are needed. McShane explains that TB vaccine efficacy trials involve 1,000s to 10,000s of subjects, cost tens of millions of dollars and can take more than five years to complete. With minimal funding, researchers have to carefully select which drug candidates are worth the “massive undertaking” needed for these studies, she adds. Dheda says “The one factor that has retarded development is money.” Schmidt adds, “There is no market and there’s no big disease burden in high income countries… Typically, policy people make money available for diseases that they feel close to.”. A lack of funding also slowed the development of the M72 vaccine. We need a Phase III study, but it’s been five years and the Phase III study for M72 hasn’t started yet,” says Dheda. Results from the Phase II trial were released for the vaccine in September 2018. Accounting for the time needed to complete the trial, publish results and manufacture the vaccine, if successful, market access to TB vaccines may be 10 years away. Clinical trials for TB are mostly funded through philanthropic means, but McShane says funding has seen fair improvement over the years, which has allowed for the recent progress in the field. Poverty and overcrowding, key factors leading to TB spreads, are challenging to tackle on a global level. “If we really want to impact TB our only hope is to have a good vaccine that can control TB, because better diagnostics and drugs , which we do have, aren’t doing the trick,” says Dheda. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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Phase 2VaccinePhase 3Phase 1Clinical Result

06 Mar 2023

·www.sciencedaily.com

Temperature-stable TB vaccine safe, prompts immune response

A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. A non-temperature stable form of the candidate previously had been tested in several clinical trials. However, this was the first clinical trial of any subunit TB vaccine candidate in a temperature-stable (thermostable) form. Results are published in Nature Communications. The experimental vaccine, ID93+GLA-SE, was developed by Christopher B. Fox, Ph.D., and scientists at the Access to Advanced Health Institute (formerly the Infectious Disease Research Institute) in Seattle. It is a recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis bacteria combined with GLA-SE, an immune-stimulating adjuvant. The freeze-dried formulation does not require refrigeration and is mixed with sterile water just prior to injection. Thermostable vaccines are desirable in settings where maintaining cold or frozen vaccines for long periods can be costly and difficult. The current trial investigated whether administering temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection. A single-vial presentation of a thermostable vaccine would have clear advantages in ease of storage, transport and administration, the investigators note. Daniel F. Hoft, M.D., Ph.D., director of the Saint Louis University Center for Vaccine Development, led the single-site trial at the university's School of Medicine. Twenty-three participants received the thermostable single-vial regimen, while 22 participants received the two-vial, non-thermostable regimen. Both vaccine presentations were safe and well-tolerated. Recipients of the single-vialled thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those receiving the non-thermostable two-vial presentation. The investigators note some limitations in this small trial. For example, no established correlates of protection define what immune responses are required for vaccine-induced protection from TB disease. Therefore, it is not possible to say whether the enhanced immune responses seen in the thermostable vaccine formulation would translate to improved protective vaccine efficacy. Nevertheless, they conclude, results of this trial demonstrate "a proof-of-concept that adjuvant-containing vaccines can be formulated in a freeze-dried single-vial presentation without detrimentally impacting clinical immunogenicity or safety characteristics."

Clinical ResultVaccinePhase 1Immunotherapy

100 Deals associated with Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 2	-	Infectious Disease Research Institute	-
Pulmonary Tuberculosis	Phase 2	-	Aeras Technologies LLC	-
Tuberculosis	Preclinical	KR	Infectious Disease Research Institute	26 May 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03722472 (CTgov)	Phase 1	Pulmonary Tuberculosis	48	GLA+ID93 (Single-vial Presentation ID93 + GLA-SE)	mzyjeasbnx(ghqsjwdwuz) = jukdzyenbh ymyczcsefi (fujzowwdwy, wvvdrdypjx - zanupwwrll) View more	-	01 Jun 2023
				GLA (Two-vial Presentation ID93 + GLA-SE)	mzyjeasbnx(ghqsjwdwuz) = riwjpkkgud ymyczcsefi (fujzowwdwy, rlklkwnqjr - qajnevpmwu) View more
NCT02465216 (CTgov)	Phase 2	Pulmonary Tuberculosis	60	ID93 + GLA-SE (2 mcg ID93 + 2 mcg GLA-SE Vaccine)	fkmuotrjfd(fljfeygtbb) = kiixjqfjpp bjqautfled (sugotxiaxm, bmcxxieyaw - grkzpbwsiu) View more	-	09 Nov 2018
				ID93 + GLA-SE (10 mcg ID93 + 2 mcg GLA-SE Vaccine)	fkmuotrjfd(fljfeygtbb) = yjcjjejihg bjqautfled (sugotxiaxm, ekfprlhzmi - bqjhifmsvz) View more

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Tuberculosis vaccine adjuvanted(Infectious Disease Research Institute)

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