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

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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

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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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28

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

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·EClinicalMedicine

A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in Mycobacterium tuberculosis-uninfected adolescents in Cape Town, South Africa

Article

Author: Andersen, Peter L ; Andersen-Nissen, Erica ; Ruhwald, Morten ; Ginsberg, Ann ; DiazGranados, Carlos A ; De Rosa, Stephen C ; Rutkowski, Kathryn T ; Seaton, Kelly E ; McElrath, M Juliana ; Dintwe, One ; Hutter, Julia ; Randhawa, April K ; Williams, Anthony ; Miner, Maurine D ; Middelkoop, Keren ; Kublin, James G ; Tait, Dereck ; Tomaras, Georgia D ; Fiore-Gartland, Andrew ; Bekker, Linda-Gail ; Kromann, Ingrid

BACKGROUNDTuberculosis (TB) remains the leading cause of infectious disease-related death. Recently, a trial of BCG revaccination and vaccination with H4:IC31, a recombinant protein vaccine, in South African adolescents (Aeras C-040-404) showed efficacy in preventing sustained QuantiFERON (QFT) conversion, a proxy for Mycobacterium tuberculosis (M.tb) infection. A phase 1b trial of 84 South African adolescents was conducted, concurrent with Aeras C-040-404, to assess the safety and immunogenicity of H4:IC31, H56:IC31 and BCG revaccination, and to identify and optimize immune assays for identification of candidate correlates of protection in efficacy trials.METHODSTwo doses of H4:IC31 and H56:IC31 vaccines were administered intramuscularly (IM) 56 days apart, and a single dose of BCG (2-8 × 10⁵ CFU) was administered intradermally (ID). T-cell and antibody responses were measured using intracellular cytokine staining and binding antibody assays, respectively. Binding antibodies and CD4+/CD8+ T-cell responses to H4- and H56-matched antigens were measured in samples from all participants. The study was designed to characterize safety and immunogenicity and was not powered for group comparisons. (Clinicaltrials.gov NCT02378207).FINDINGSIn total, 481 adolescents (mean age 13·9 years) were screened; 84 were enrolled (54% female). The vaccines were generally safe and well-tolerated, with no reported severe adverse events related to the study vaccines. H4:IC31 and H56:IC31 elicited CD4+ T cells recognizing vaccine-matched antigens and H4- and H56-specific IgG binding antibodies. The highest vaccine-induced CD4+ T-cell response rates were for those recognizing Ag85B in the H4:IC31 and H56:IC31 vaccinated groups. BCG revaccination elicited robust, polyfunctional BCG-specific CD4+ T cells, with no increase in H4- or H56-specific IgG binding antibodies. There were few antigen-specific CD8+ T-cell responses detected in any group.INTERPRETATIONBCG revaccination administered as a single dose ID and both H4:IC31 and H56:IC31 administered as 2 doses IM had acceptable safety profiles in healthy, QFT-negative, previously BCG-vaccinated adolescents. Characterization of the assays and the immunogenicity of these vaccines may help to identify valuable markers of protection for upcoming immune correlates analyses of C-040-404 and future TB vaccine efficacy trials.FUNDINGNIAID and Aeras.

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)	itripyzufw(qekkvhaeil) = cejtidwauc xuhzjqbmrn (ahutqcxehl, btfdlbuqof - ugkomntefq) View more	-	18 Nov 2019
				H56:IC31 (Gr 1 H56:IC31 5/500)	jwycbzajyz(iafohhefzu) = vjrowtcdei hpanuczmjn (nzjafxosni, braeuxohwr - luwibxidga) View more
NCT02378207 (CTgov)	Phase 1	Tuberculosis	84	H4:IC31 (Group 1 H4:IC31)	kceaslketd(hcsihfmxjl) = xdzsdhmqka hojgntbpuu (tmvirnwufy, fapdxijpxi - ljpgesvyiq) View more	-	18 Nov 2019
				H56:IC31 (Group 2 H56:IC31)	kceaslketd(hcsihfmxjl) = zuxxgcmhjj hojgntbpuu (tmvirnwufy, bdzwcpkkcw - vcjztuhlha) View more
NCT01967134 (CTgov)	Phase 1	Latent Tuberculosis	25	H56:IC31 (H56:IC31 (50 ug H56) LTBI Neg)	gbdibjqdtx(nwczidnlwi) = rawxnbmwdv eyujpszpwd (uqcxkoygvi, mkzmdmqxsa - kbvifnoihp) View more	-	21 Aug 2019
				H56:IC31 (H56:IC31 (15 ug H56) LTBI Pos)	gbdibjqdtx(nwczidnlwi) = zcxhlxnqng eyujpszpwd (uqcxkoygvi, jsvzgahzui - xwsvaqlbzr) View more