Delving into the Latest Updates on Tuberculosis vaccine(Aeras Technologies LLC) with Synapse

Overview

Basic Info

Drug Type

Recombinant vector vaccine, Prophylactic vaccine

Synonyms

Tuberculosis vaccine

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Pulmonary TuberculosisTuberculosis

Inactive Indication-

Originator Organization

Aeras Technologies LLC

Active Organization

Crucell Holdings, Inc.

Crucell

Aeras Technologies LLC

+ [3]

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.

Start Date01 Sep 2012

Sponsor / Collaborator

University of Oxford

[+4]

NCT01378312 / CompletedPhase 1IIT

A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection

This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India.
The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.

Start Date01 Feb 2011

Sponsor / Collaborator

Aeras Global TB Vaccine Foundation

100 Clinical Results associated with Tuberculosis vaccine(Aeras Technologies LLC)

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100 Translational Medicine associated with Tuberculosis vaccine(Aeras Technologies LLC)

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100 Patents (Medical) associated with Tuberculosis vaccine(Aeras Technologies LLC)

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877

Literatures (Medical) associated with Tuberculosis vaccine(Aeras Technologies LLC)

01 Dec 2024·International Journal of Pharmaceutics

Evaluation of PLGA, lipid-PLGA hybrid nanoparticles, and cationic pH-sensitive liposomes as tuberculosis vaccine delivery systems in a Mycobacterium tuberculosis challenge mouse model – A comparison

Article

Author: Geluk, Annemieke ; Limpens, Ronald W A L ; van Veen, Suzanne ; Franken, Kees L.M.C. ; van den Eeden, Susan J F ; Franken, Kees L M C ; Ottenhoff, Tom H M ; van Veen, S. ; van Meijgaarden, Krista E ; Neustrup, Malene A ; Szachniewicz, M.M. ; Bouwstra, J.A. ; Szachniewicz, Mikołaj M ; Neustrup, M.A. ; van den Eeden, S.J.F. ; Koning, R.I. ; Limpens, R.W.A.L. ; Koning, Roman I ; van Meijgaarden, K.E. ; Geluk, A. ; Bouwstra, Joke A ; Ottenhoff, T.H.M.

Tuberculosis (TB) continues to pose a global threat for millennia, currently affecting over 2 billion people and causing 10.6 million new cases and 1.3 million deaths annually. The only existing vaccine, Mycobacterium Bovis Bacillus Calmette-Guérin (BCG), provides highly variable and inadequate protection in adults and adolescents. This study explores newly developed subunit tuberculosis vaccines that use a multistage protein fusion antigen Ag85b-ESAT6-Rv2034 (AER). The protection efficacy, as well as in vivo induced immune responses, were compared for five vaccines: BCG; AER-CpG/MPLA mix; poly(D,L-lactic-co-glycolic acid) (PLGA); lipid-PLGA hybrid nanoparticles (NPs); and cationic pH-sensitive liposomes (the latter three delivering AER together with CpG and MPLA). All vaccines, except the AER-adjuvant mix, induced protection in Mycobacterium tuberculosis (Mtb)-challenged C57/Bl6 mice as indicated by a significant reduction in bacterial burden in lungs and spleens of the animals. Four AER-based vaccines significantly increased the number of circulating multifunctional CD4⁺ and CD8⁺ T-cells producing IL-2, IFNγ, and TNFα, exhibiting a central memory phenotype. Furthermore, AER-based vaccines induced an increase in CD69⁺ B-cell counts as well as high antigen-specific antibody titers. Unexpectedly, none of the observed immune responses were associated with the bacterial burden outcome, such that the mechanism responsible for the observed vaccine-induced protection of these vaccines remains unclear. These findings suggest the existence of non-classical protective mechanisms for Mtb infection, which could, once identified, provide interesting targets for novel vaccines.

01 Oct 2024·European Journal of Pharmaceutics and Biopharmaceutics

Cationic pH-sensitive liposome-based subunit tuberculosis vaccine induces protection in mice challenged with Mycobacterium tuberculosis

Article

Author: Geluk, A ; Bouwstra, J A ; van den Eeden, S J F ; Szachniewicz, M M ; van Meijgaarden, K E ; Franken, K L M C ; van Veen, S ; Ottenhoff, T H M

Tuberculosis (TB) has been and still is a global emergency for centuries. Prevention of disease through vaccination would have a major impact on disease prevalence, but the only available current vaccine, BCG, has insufficient impact. In this article, a novel subunit vaccine against TB was developed, using the Ag85B-ESAT6-Rv2034 fusion antigen, two adjuvants - CpG and MPLA, and a cationic pH-sensitive liposome as a delivery system, representing a new TB vaccine delivery strategy not previously reported for TB. In vitro in human dendritic cells (DCs), the adjuvanted formulation induced a significant increase in the production of (innate) cytokines and chemokines compared to the liposome without additional adjuvants. In vivo, the new vaccine administrated subcutaneously significantly reduced Mycobacterium tuberculosis (Mtb) bacterial load in the lungs and spleens of mice, significantly outperforming results from mice vaccinated with the antigen mixed with adjuvants without liposomes. In-depth analysis underpinned the vaccine's effectiveness in terms of its capacity to induce polyfunctional CD4⁺ and CD8⁺ T-cell responses, both considered essential for controlling Mtb infection. Also noteworthy was the differential abundance of various CD69⁺ B-cell subpopulations, which included IL17-A-producing B-cells. The vaccine stimulated robust antigen-specific antibody titers, further extending its potential as a novel protective agent against TB.

01 Oct 2024·The Lancet Microbe

Implications of subclinical tuberculosis for vaccine trial design and global effect

Review

Author: Houben, Rein M G J ; Schmidt, Alexander C ; Mave, Vidya ; Behr, Marcel ; Fiore-Gartland, Andrew L ; White, Richard G ; Fielding, Katherine ; Grant, Alison D ; Wong, Emily B ; Hanekom, Willem A ; Hatherill, Mark ; Dagnew, Alemnew F ; Garcia-Basteiro, Alberto L ; Churchyard, Gavin J ; Esmail, Hanif ; Cobelens, Frank ; Rangaka, Molebogeng X

Tuberculosis is a leading cause of death from an infectious agent globally. Infectious subclinical tuberculosis accounts for almost half of all tuberculosis cases in national tuberculosis prevalence surveys, and possibly contributes to transmission and might be associated with morbidity. Modelling studies suggest that new tuberculosis vaccines could have substantial health and economic effects, partly based on the assumptions made regarding subclinical tuberculosis. Evaluating the efficacy of prevention of disease tuberculosis vaccines intended for preventing both clinical and subclinical tuberculosis is a priority. Incorporation of subclinical tuberculosis as a composite endpoint in tuberculosis vaccine trials can help to reduce the sample size and duration of follow-up and to evaluate the efficacy of tuberculosis vaccines in preventing clinical and subclinical tuberculosis. Several design options with various benefits, limitations, and ethical considerations are possible in this regard, which would allow for the generation of the evidence needed to estimate the positive global effects of tuberculosis vaccine trials, in addition to informing policy and vaccination strategies.

100 Deals associated with Tuberculosis vaccine(Aeras Technologies LLC)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Tuberculosis	Phase 3	KE	Aeras Global TB Vaccine Foundation	01 Sep 2010
Tuberculosis	Phase 3	MZ	Aeras Global TB Vaccine Foundation	01 Sep 2010
Tuberculosis	Phase 3	ZA	Aeras Global TB Vaccine Foundation	01 Sep 2010
Pulmonary Tuberculosis	Phase 2	-	National Institutes of Health	-
Pulmonary Tuberculosis	Phase 2	-	Crucell Holdings, Inc.	-
Pulmonary Tuberculosis	Phase 2	-	Aeras Technologies LLC	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02414828 (Pubmed \| Pediatrics) Manual	Phase 2	Tuberculosis	72	AERAS-402	(badfceqsss) = xujmdjmfyh bpgmpiewzx (kodawzhgxo )	Positive	01 May 2017
				Placebo	(badfceqsss) = qflpqdbfwd bpgmpiewzx (kodawzhgxo )
NCT02414828 (C-010-402, CTgov)	Phase 2	Pulmonary Tuberculosis	72	Placebo (Placebo)	ycbnwvvlsh(vxxgwnkqjl) = avkncnhgmn ubdjnglmwm (gckojobvxo, kbafhpricw - ecihilmmdr) View more	-	04 May 2016
				AERAS-402 3 x 10^8 vp (AERAS-402 3 x 10^8 vp)	ycbnwvvlsh(vxxgwnkqjl) = lwlchwsmrs ubdjnglmwm (gckojobvxo, elyvedpusf - qfessmtarv) View more
NCT01198366 (CTgov)	Phase 1/2	Tuberculosis	487	placebo (Dose Finding - Group 1)	tbnwjgzrvo(glbucbbhgp) = ehpemekqjb kfvwkjdpzj (cnmmdgnbao, lhktggbpln - oudgivyvsf) View more	-	04 Aug 2015
				AERAS-402 (Dose Finding - Group 2)	tbnwjgzrvo(glbucbbhgp) = bfndbanofk kfvwkjdpzj (cnmmdgnbao, chtjwseiet - yfhvhxuwxr) View more
NCT01017536 (CTgov)	Phase 2	Tuberculosis \| HIV Infections	26	Placebo (Placebo)	cmgvpijnpj(pizpnaipgy) = qtrchuhhhi whlufddmsd (odsxxhiuuo, cgiuhnuwfx - kowjoqcliy) View more	-	13 Oct 2014
				AERAS-402 (Investigational Vaccine)	cmgvpijnpj(pizpnaipgy) = kmwtxglifk whlufddmsd (odsxxhiuuo, rpjidkeihe - rugpeyqwwh) View more