Delving into the Latest Updates on Tuberculosis vaccine H56IC(Statens Serum Institute) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Adjuvanted TB subunit vaccine H56IC, H56/IC31 vaccine, Tuberculosis vaccine H56IC

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

TuberculosisPulmonary Tuberculosis

Inactive Indication

Latent TuberculosisTuberculosis, Multidrug-Resistant

Originator Organization

Statens Serum Institute

Active Organization

Statens Serum Institute

Aeras Technologies LLC

European & Developing Countries Clinical Trials Partnership

+ [1]

Inactive Organization

Aj Vaccines A/S

Oslo universitetssykehus HF

Aeras Global TB Vaccine Foundation

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups.
H56:IC31 (investigational vaccine)
Placebo
900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics with established relationships to the trial sites at the start of their TB treatment.
5 study sites in South Africa: 2 sites from the AURUM institute (Klerksdorp and Tembisa) and 3 in Cape Town at TASK Applied Science (TASK), the University of Cape Town Lung Institute (UCTLI) and South African Tuberculosis Vaccine Initiative (SATVI) under UCT, respectively.
1 study site in Tanzania (TZ): 1 site at Mbeya Medical Research Centre (MMRC) under the National Institute for Medical Research (NIMR).

Start Date31 Jan 2019

Sponsor / Collaborator

International AIDS Vaccine Initiative, Inc.

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NCT03265977 / WithdrawnPhase 2IIT

A Randomized, Placebo Controlled, Double-Blind Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection With Mycobacterium Tuberculosis (Mtb) of H56:IC31 in Healthy Adolescents

This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.

Start Date01 Jun 2018

Sponsor / Collaborator

Aeras Global TB Vaccine Foundation

[+6]

100 Clinical Results associated with Tuberculosis vaccine H56IC(Statens Serum Institute)

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100 Translational Medicine associated with Tuberculosis vaccine H56IC(Statens Serum Institute)

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100 Patents (Medical) associated with Tuberculosis vaccine H56IC(Statens Serum Institute)

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27

Literatures (Medical) associated with Tuberculosis vaccine H56IC(Statens Serum Institute)

15 Nov 2024·The Journal of Infectious Diseases

Safety and Immunogenicity of the H56:IC31 Tuberculosis Vaccine Candidate in Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis: A Phase 1 Randomized Trial

Article

Author: Churchyard, Gavin ; Tait, Dereck ; Russell, Marisa ; Hokey, David ; Andersen, Peter L ; Dawson, Rodney ; Diacon, Andreas ; Kromann, Ingrid ; van Brakel, Elana ; Ruhwald, Morten ; Hunt, Devin J ; Borges, Álvaro H ; Rutkowski, Kathryn T

AbstractBackgroundH56:IC31 is a candidate vaccine against tuberculosis (TB) with the potential to reduce TB recurrence rate. It is thus important for future clinical trials to demonstrate safety and immunogenicity of H56:IC31 in individuals treated for TB.MethodsTwenty-two adults confirmed to be Mycobacterium tuberculosis negative (by 2 GeneXpert tests or 2 sputum cultures) after 4–5 months of TB treatment, and not more than 28 days after completion of TB treatment, were randomized to receive 2 doses of H56:IC31 (5 mg H56:500 nmol IC31; n = 16) or placebo (n = 6) 56 days apart. Participants were followed for 420 days for safety and immunogenicity.ResultsH56:IC31 vaccination was associated with an acceptable safety profile, consisting mostly of mild self-limited injection site reactions. No serious adverse events or vaccine-related severe adverse events were reported. H56:IC31 induced a CD4+ T-cell response for Ag85B and ESAT-6, with ESAT-6 being immunodominant, which persisted through 6 months after the last vaccination. There was some evidence of CD8+ T-cell responses for both Ag85B and ESAT-6, but to a lesser extent than CD4+ responses.ConclusionsH56:IC31 was associated with an acceptable safety profile, and induced a predominant CD4+ T-cell response, in adults recently treated for drug-susceptible, uncomplicated pulmonary TB.Clinical Trials RegistrationNCT02375698.

01 Jun 2020·Seminars in ImmunopathologyQ2 · MEDICINE

Towards new TB vaccines

Q2 · MEDICINE

Review

Author: McShane, Helen ; Brazier, Benedict

AbstractMycobacterium tuberculosisremains the leading cause of death attributed to a single infectious organism. Bacillus Calmette-Guerin (BCG), the standard vaccine againstM. tuberculosis, is thought to prevent only 5% of all vaccine-preventable deaths due to tuberculosis, thus an alternative vaccine is required. One of the principal barriers to vaccine development againstM. tuberculosisis the complexity of the immune response to infection, with uncertainty as to what constitutes an immunological correlate of protection. In this paper, we seek to give an overview of the immunology ofM. tuberculosisinfection, and by doing so, investigate possible targets of vaccine development. This encompasses the innate, adaptive, mucosal and humoral immune systems. Though MVA85A did not improve protection compared with BCG alone in a large-scale clinical trial, the correlates of protection this has revealed, in addition to promising results from candidate such as VPM1002, M72/ASO1E and H56:IC31 point to a brighter future in the field of TB vaccine development.

01 Apr 2020·Medical Microbiology and ImmunologyQ4 · MEDICINE

Toll like-receptor agonist Pam3Cys modulates the immunogenicity of liposomes containing the tuberculosis vaccine candidate H56

Q4 · MEDICINE

Article

Author: Stenger, Steffen ; Kennerknecht, Kathrin ; Wehrstedt, Stephanie ; Pedersen, Gabriel Kristian ; Noschka, Reiner ; Grieshober, Mark ; Löffler, Florian ; Mayer, Daniel ; Christensen, Dennis

AbstractA major roadblock in the development of novel vaccines is the formulation and delivery of the antigen. Liposomes composed of a dimethyldioctadecylammonium (DDA) backbone and the adjuvant trehalose-6-6-dibehenate (TDB, termed “cationic adjuvant formulation (CAF01)”, promote immunogenicity and protective efficacy of vaccines, most notably against infection with Mycobacterium tuberculosis. Specifically, the multicomponent antigen H56 delivered by CAF01 protects against tuberculosis in mice. Here we investigated whether the inclusion of immune-modulatory adjuvants into CAF01 modulates the immunogenicity of H56/CAF01 in vitro and in vivo. Based on our recent findings we selected the active sequence of the mycobacterial 19 kDa lipoprotein, Pam3Cys, which interacts with Toll like receptor 2 to induce an antimicrobial pathway. H56/CAF01-Pam3Cys liposomes were characterized for Pam3Cys incorporation, size, toxicity and activation of primary human macrophages. Macrophages efficiently take up H56/CAF01-Pam3Cys and trigger the release of significantly higher levels of TNF, IL-12 and IL-10 than H56/CAF01 alone. To evaluate the immunogenicity in vivo, we immunized mice with H56/CAF01-Pam3Cys and measured the release of IFN-γ and IL-17A by lymph node cells and spleen cells. While the antigen-specific production of IFN-γ was reduced by inclusion of Pam3Cys into H56/CAF01, the levels of IL-17A remained unchanged. In agreement with this finding, the concentration of the IFN-γ-associated IgG2a antibodies in the serum was lower than in H56/CAF01 immunized animals. These results provide proof of concept that Toll like-receptor agonist can be included into liposomes to modulate immune responses. The discordant results between the in vitro studies with human macrophages and in vivo studies in mice highlight the relevance and complexity of comparing immune responses in different species

100 Deals associated with Tuberculosis vaccine H56IC(Statens Serum Institute)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 2	-	Aeras Technologies LLC	-
Tuberculosis	Phase 1	ZA	Statens Serum Institute	01 Jun 2018
Tuberculosis	Phase 1	TZ	Statens Serum Institute	01 Jun 2018
Tuberculosis	Phase 1	TZ	Statens Serum Institute	01 Jun 2018
Tuberculosis	Phase 1	ZA	Statens Serum Institute	01 Jun 2018
Tuberculosis, Multidrug-Resistant	Phase 1	NO	Oslo universitetssykehus HF	01 Nov 2015
Latent Tuberculosis	Phase 1	ZA	Statens Serum Institute	01 Aug 2013
Latent Tuberculosis	Phase 1	ZA	Aeras Global TB Vaccine Foundation	01 Aug 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02375698 (C-037-456, CTgov)	Phase 1	Pulmonary Tuberculosis	22	Placebo (Placebo)	ykunzuzqsa(rkixksgavv) = toeeevfhgo iqvtvhrkcv (oklyztzqaw, uobzexknlt - slgrrljfjv) View more	-	18 Nov 2019
				H56:IC31 (Gr 1 H56:IC31 5/500)	fpvlpgphka(rcquqqduka) = jcpirfjrtn ihxfwvspne (jjzshcskzi, swyxrfhlgf - fodxzbdzlj) View more
NCT02378207 (CTgov)	Phase 1	Tuberculosis	84	H4:IC31 (Group 1 H4:IC31)	hhcuocvfvm(deuyseyfxs) = cpllbkaftn jjfocydcqi (kppkkzusvn, alxedglyvp - dosnitnfhq) View more	-	18 Nov 2019
				H56:IC31 (Group 2 H56:IC31)	hhcuocvfvm(deuyseyfxs) = lfhrflwhib jjfocydcqi (kppkkzusvn, gjmcyfewvw - mlsevmyrhw) View more
NCT01967134 (CTgov)	Phase 1	Latent Tuberculosis	25	H56:IC31 (H56:IC31 (50 ug H56) LTBI Neg)	colfrsejsf(tcfuccrmqt) = lpgvhdqlpw fdxkrhubvk (jhqwdmuhmb, nqmropivkz - hurhmwkory) View more	-	21 Aug 2019
				H56:IC31 (H56:IC31 (15 ug H56) LTBI Pos)	colfrsejsf(tcfuccrmqt) = lycfqufihk fdxkrhubvk (jhqwdmuhmb, gelvjwxonw - vzskzozomg) View more