Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a leading cause of mortality and morbidity due to a single infectious agent. Aerosol infection with Mtb can result in a range of responses from elimination, active, incipient, subclinical, and latent Mtb infections (LTBI), depending on the host's immune response and the dose and nature of infecting bacilli. Currently, BCG is the only vaccine approved to prevent TB. Although BCG confers protection against severe forms of childhood TB, its use in adults and those with comorbid conditions, such as HIV infection, is questionable. Novel vaccines, including recombinant BCG (rBCG), were developed to improve BCG's efficacy and use as an alternative to BCG in a vulnerable population. The first-generation rBCG vaccines had different Mtb antigens and were tested as a prime, prime-boost, or immunotherapeutic intervention. The novel vaccines target one or more of the following requirements, namely prevention of infection (POI), prevention of disease (POD), prevention of recurrence (POR), and therapeutic vaccines to treat a TB disease. Several vaccine candidates currently in development are classified into four primary categories: live attenuated whole-cell vaccine, inactivated whole-cell vaccine, adjuvanted protein subunit vaccine, and viral-vectored vaccine. Each vaccine's immunogenicity, safety, and efficacy are tested in preclinical animal models and further validated through various phases of clinical trials. This chapter summarizes the various TB vaccine candidates under different clinical trial stages and promises better protection against TB.

01 Dec 2018·TrialsQ4 · MEDICINE

A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area

Q4 · MEDICINE

ArticleOA

Author: Ahmed, Jemal ; Hussein, Jemal ; Zewdie, Martha ; Bang, Peter ; Aseffa, Abraham ; Engers, Howard ; Chanyalew, Menberework ; Kromann, Ingrid ; Dagnew, Alemnew F ; Hoff, Søren T ; Doherty, T Mark ; Yamuah, Lawrence ; Abebe, Markos ; Bedru, Ahmed ; Yohannes, Asfawesen G

BACKGROUNDH1/IC31® is a tuberculosis (TB) subunit vaccine candidate consisting of the fusion protein of Ag85B and ESAT-6 (H1) formulated with the IC31® adjuvant. Previous trials have reported on the H1/IC31® vaccine in M. tuberculosis (Mtb)-naïve, BCG-vaccinated and previously Mtb-infected individuals. In this trial, conducted between December 2008 and April 2010, the safety and immunogenicity of H1/IC31® was assessed in participants living in Ethiopia - a highly TB-endemic area.METHODSHealthy male participants aged 18-25 years were recruited into four groups. Participants in group 1 (N = 12) and group 2 (N = 12) were Tuberculin Skin Test (TST) negative and QuantiFERON-TB Gold in-tube test (QFT) negative (Mtb-naïve groups), participants in group 3 (N = 3) were TST positive and QFT negative (BCG group), and participants in group 4 (N = 12) were both TST and QFT positive (Mtb-infected group). H1 vaccine alone (group 1) or H1 formulated with the adjuvant IC31® (groups 2, 3 and 4) was administered intramuscularly on day 0 and day 56. Safety and immunogenicity parameters were evaluated for up to 32 weeks after day 0.RESULTSThe H1/IC31®vaccine was safe and generally well tolerated. There was little difference among the four groups, with a tendency towards a higher incidence of adverse events in Mtb-infected compared to Mtb-naïve participants. Two serious adverse events were reported in the Mtb-infected group where a relationship to the vaccine could not be excluded. In both cases the participants recovered without sequelae within 72 h. Immunogenicity assays, evaluated in the 29 participants who received both vaccinations, showed a stronger response to TB antigens in the Mtb-naïve group vaccinated with the adjuvant.CONCLUSIONThe trial confirmed the need for an adjuvant for the vaccine to be immunogenic and highlighted the importance of early phase testing of a novel TB vaccine candidate in TB-endemic areas.TRIAL REGISTRATIONClinicalTrials.gov, ID: NCT01049282. Retrospectively registered on 14 January 2010.

01 Jul 2015·Clinical and Vaccine Immunology

Antiviral Innate Immune Activation in HIV-Infected Adults Negatively Affects H1/IC31-Induced Vaccine-Specific Memory CD4⁺T Cells

Article

Author: Peter Bang ; Tedson Lukindo ; Gavin J. Churchyard ; Nicole Lenz ; Maxmillian Mpina ; Klaus Reither ; Jitao David Zhang ; Søren T. Hoff ; Tobias Schindler ; Peter Andersen ; Ingrid Kromann ; Benjamin M. Kagina ; Claudia A. Daubenberger ; Ulrich Certa

ABSTRACTTuberculosis (TB) remains a global health problem, with vaccination being a necessary strategy for disease containment and elimination. A TB vaccine should be safe and immunogenic as well as efficacious in all affected populations, including HIV-infected individuals. We investigated the induction and maintenance of vaccine-induced memory CD4+T cells following vaccination with the subunit vaccine H1/IC31. H1/IC31 was inoculated twice on study days 0 and 56 among HIV-infected adults with CD4+lymphocyte counts of >350 cells/mm3. Whole venous blood stimulation was conducted with the H1 protein, and memory CD4+T cells were analyzed using intracellular cytokine staining and polychromatic flow cytometry. We identified high responders, intermediate responders, and nonresponders based on detection of interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), and gamma interferon (IFN-γ) expressing central (TCM) and effector memory CD4+T cells (TEM) 182 days after the first immunization. Amplicon-based transcript quantification using next-generation sequencing was performed to identify differentially expressed genes that correlated with vaccine-induced immune responses. Genes implicated in resolution of inflammation discriminated the responders from the nonresponders 3 days after the first inoculation. The volunteers with higher expression levels of genes involved in antiviral innate immunity at baseline showed impaired H1-specific TCMand TEMmaintenance 6 months after vaccination. Our study showed that in HIV-infected volunteers, expression levels of genes involved in the antiviral innate immune response affected long-term maintenance of H1/IC31 vaccine-induced cellular immunity. (The clinical trial was registered in the Pan African Clinical Trials Registry [PACTR] with the identifier PACTR201105000289276.)

100 Deals associated with Tuberculosis vaccine H1IC(Intercell AG)

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 2	-	Valneva SE	-
Pulmonary Tuberculosis	Phase 2	-	Statens Serum Institute	-
Tuberculosis	Phase 1	TZ	-	-
Tuberculosis	Preclinical	ZA	-	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2014	Not Applicable	-	48	H1/IC31® vaccine	iacdjrhgyp(xajmhhrehx) = bnxkbfzlvl wyphtvznkg (uqyehmfbvj )	-	01 Jan 2014
				Placebo	iacdjrhgyp(xajmhhrehx) = piayjvrwbu wyphtvznkg (uqyehmfbvj )

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