- |||||||||| Review, Journal, Metastases: Therapeutic vaccines for advanced non-small cell lung cancer. (Pubmed Central) - Mar 16, 2024
There were no differences between the compared treatments in serious treatment-related adverse events, except for SRL172 (killed Mycobacterium vaccae) added to chemotherapy, which was associated with an increase in the proportion of participants with at least one serious treatment-related adverse event, and OSE2101, which may decrease slightly the proportion of people having at least one serious treatment-related adverse event. These conclusions should be interpreted cautiously, as the very low- to moderate-certainty evidence prevents drawing solid many vaccines were evaluated in a single study with small numbers of participants and events.
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Preclinical, Journal: Effects of Mycobacterium vaccae NCTC 11659 and Lipopolysaccharide Challenge on Polarization of Murine BV-2 Microglial Cells. (Pubmed Central) - Jan 15, 2024
In contrast, among LPS-challenged cells, although M. vaccae NCTC 11659 did not fully prevent the effects of LPS relative to vehicle-treated control conditions, it increased Arg1 mRNA expression, suggesting that M. vaccae NCTC 11659 induces an atypical microglial phenotype. Thus, M. vaccae NCTC 11659 acutely (within 48 h) induced immune-activating and microglial-priming effects when applied directly to murine BV-2 microglial cells, in contrast to its long-term anti-inflammatory and immunoregulatory effects observed on the CNS when whole-cell, heat-killed preparations of M. vaccae NCTC 11659 were given peripherally in vivo.
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Effects of a soil Mycobacterium-derived lipid, 10(Z)-hexadecenoic acid, on murine dendritic cells: A mechanistic analysis (WCC Halls A-C) - Nov 3, 2023 - Abstract #Neuroscience2023NEUROSCIENCE_12121;
Mycobacterium vaccae NCTC 11659, a soil-derived mycobacterium with anti-inflammatory, immunoregulatory, and stress resilience effects is one such "Old Friend"...This suggests that Il6 expression in murine BMDCs is controlled in part by PPAR?. These results further our understanding of the mechanism by which 10(Z)-HDA has its effects and of understanding host mycobacteria interactions.
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Preclinical, Journal, Combination therapy: Subcutaneous Mycobacterium vaccae ameliorates the effects of early life adversity alone or in combination with chronic stress during adulthood in male and female mice. (Pubmed Central) - Sep 20, 2023
Finally, our data support the hypothesis that female mice are more vulnerable to the additive effects of ELA and CAS than male mice and that s.c. M. vaccae administrations subsequent to ELA but prior to CAS are protective in both sexes. Taken together and considering the limitation that CAS in males and females was induced by different paradigms, our findings are consistent with the hypotheses that murine stress vulnerability during different phases of life is strongly sex dependent and that developing immunoregulatory approaches, such as repeated s.c. administrations with immunoregulatory microorganisms, have potential for prevention/treatment of stress-related disorders.
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Preclinical, Journal, IO biomarker: Mycobacterium vaccae protects against glucocorticoid resistance resulting from combined physical and psychosocial trauma in mice. (Pubmed Central) - Mar 15, 2023
In contrast, the protective effects of i.g. M. vaccae on the CSC-induced upregulation of TLR2 in neutrophils and the subsequent increase in basal and LPS-induced in vitro splenocyte viability seems to be indirectly mediated via the Treg compartment. These data highlight the potential for use of oral administration of M. vaccae NCTC 11659 to prevent stress-induced exaggeration of inflammation, a risk factor for development of stress-related psychiatric disorders.
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Journal: Evolutionary Aspects of Diverse Microbial Exposures and Mental Health: Focus on "Old Friends" and Stress Resilience. (Pubmed Central) - Feb 27, 2023
We highlight evidence that microbial signals that can drive immunoregulation arise from phylogenetically diverse taxa but are strain specific. Finally, we highlight Mycobacterium vaccae NCTC 11659, a soil-derived bacterium with anti-inflammatory and immunoregulatory properties, as a case study of how single strains of bacteria might be used in a psychoneuroimmunologic approach for prevention and treatment of stress-related psychiatric disorders.
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Effects of 10(Z)-hexadecenoic acid, a lipid isolated from Mycobacterium vaccae, a bacterium with anti-inflammatory, immunoregulatory, and stress resilience properties, on murine bone marrow-derived dendritic cells (BMDCs) following lipopolysaccharide (E. coli 0111: B4) challenge or control conditions (SDCC Halls B-H) - Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_2118;
In this study we investigated the effects 10(Z)-hexadecenoic acid, a lipid isolated from a soil-derived “Old Friend”, Mycobacterium vaccae NCTC 11659, with anti-inflammatory, immunoregulatory, and stress resilience properties, on the lipopolysaccharide (LPS; E. coli 0111: B4)-induced inflammatory response and the LPS-induced intracellular signaling cascades associated with dendritic cell (DC) polarization in bone marrow-derived dendritic cells (BMDCs) using the murine NanoString Inflammation V2 platform, which allows quantification of expression of 254 inflammation-related genes...These data are consistent with the hypothesis that 10(Z)-hexadecenoic acid attenuates LPS induced inflammation in BMDCs. Together, these data are consistent with the hypothesis that 10(Z)-hexadecenoic acid is a potential intervention for prevention of anxiety disorders, mood disorders, and trauma and stressor-related disorders by reducing stress- or trauma-induced exaggeration of neuroinflammation.
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Effects of Mycobacterium aurum DSM 33539 on biological signatures of stress-induced neuroinflammation and stress resilience in adult male rats (SDCC Halls B-H) - Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_2101;
In contrast, immunization with whole cell, heat-killed preparations of Mycobacterium vaccae NCTC 11659 (recently reclassified as M. kyogaense sp...Here we show that immunization with M. aurum DSM 33539 prevented inescapable stress- (IS-) induced increases in hippocampal Il6 mRNA expression and prevented IS-induced exaggeration of anxiety-like defensive behavioral responses in the juvenile social exploration paradigm, assessed 24 h after exposure to IS in adult male rats. Future studies are required to fully characterize the mechanisms through which M. aurum DSM 33539 and closely related mycobacterial strains prevent stress-induced exaggeration of neuroinflammation and promote stress resilience.
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Journal: Immunization with a heat-killed preparation of Mycobacterium vaccae NCTC 11659 enhances auditory-cued fear extinction in a stress-dependent manner. (Pubmed Central) - Sep 20, 2022
Finally, in an auditory-cued fear conditioning paradigm exploring short-term memory and fear acquisition, immunization with M. vaccae did not prevent fear acquisition, either with or without exposure to inescapable stress, consistent with the hypothesis that M. vaccae NCTC 11659 has no effect on fear acquisition but enhances fear extinction. These data are consistent with the hypothesis that increased immunoregulation following immunization with M. vaccae NCTC 11659 promotes stress resilience, in particular by preventing stress-induced resistance to fear extinction, and may be a potential therapeutic target for trauma and stressor-related disorders such as PTSD.
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Review, Journal: Rapidly Growing Mycobacterium Species: The Long and Winding Road from Tuberculosis Vaccines to Potent Stress-Resilience Agents. (Pubmed Central) - Jan 13, 2022
This historical narrative review is intended as a first step in exploring these mechanisms and provides an overview of preclinical and clinical studies on M. vaccae NCTC 11659 and related RGMs. The overall objective of this review article is to increase the comprehension of, and interest in, the mechanisms through which M. vaccae NCTC 11659 and related RGMs promote stress resilience, with the intention of fostering novel clinical strategies for the prevention and treatment of stressor-related disorders.
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Preclinical, Journal: Subcutaneous Mycobacterium vaccae promotes resilience in a mouse model of chronic psychosocial stress when administered prior to or during psychosocial stress. (Pubmed Central) - Apr 28, 2021
Although M. vaccae administered during CSC did not affect stress coping, this treatment protocol profoundly protected against CSC-induced general, and to a lesser extent social, anxiety. Taken together, these data broaden the framework for developing bioimmunoregulatory approaches, based on the administration of immunoregulatory microorganisms, for the prevention and/or treatment of affective disorders, anxiety disorders, and trauma- and stressor-related psychiatric disorders like PTSD.
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Journal: Treatment with a heat-killed preparation of Mycobacterium vaccae after fear conditioning enhances fear extinction in the fear-potentiated startle paradigm. (Pubmed Central) - Aug 5, 2020
To determine if immunization with M. vaccae after fear conditioning also has protective effects, adult male Sprague Dawley rats underwent fear conditioning on days -37 and -36 followed by immunizations (3x), once per week beginning 24 h following fear conditioning, with a heat-killed preparation of M. vaccae NCTC 11659 (0.1 mg, s.c., in 100 µl borate-buffered saline) or vehicle, and, then, 3 weeks following the final immunization, were tested in the fear-potentiated startle paradigm (n = 12 per group)...Together with previous studies, these data are consistent with the hypothesis that immunoregulatory strategies, such as immunization withM. vaccae, have potential for both prevention and treatment of trauma- and stressor-related psychiatric disorders.
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Trial primary completion date: DAR-PIA: DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (clinicaltrials.gov) - Dec 3, 2019
P2, N=650, Active, not recruiting,
These results suggest that induction of higher levels of CD4+ cytokine stimulation may not be a critical or pre-requisite characteristic for candidate TB vaccine boosters. Trial primary completion date: Nov 2019 --> Feb 2020
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Trial completion date, Trial primary completion date: DAR-PIA: DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (clinicaltrials.gov) - Mar 30, 2018
P2, N=650, Active, not recruiting,
Trial primary completion date: Nov 2019 --> Feb 2020 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Nov 2018 --> Nov 2019
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Enrollment closed, Trial primary completion date: DAR-PIA: DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (clinicaltrials.gov) - Mar 24, 2017
P2, N=650, Active, not recruiting,
Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Nov 2018 --> Nov 2019 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2018 --> Nov 2018
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Trial completion, Nontuberculous mycobacteria: Phase I Trial of DAR-901 (clinicaltrials.gov) - Aug 2, 2016
P1, N=59, Completed,
Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2018 --> Nov 2018 Active, not recruiting --> Completed
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Enrollment change, Nontuberculous mycobacteria: Phase I Trial of DAR-901 (clinicaltrials.gov) - Jan 5, 2016
P1, N=59, Active, not recruiting,
Active, not recruiting --> Completed N=77 --> 59
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Enrollment closed, Trial primary completion date, Nontuberculous mycobacteria: Phase I Trial of DAR-901 (clinicaltrials.gov) - Aug 11, 2015
P1, N=77, Active, not recruiting,
N=77 --> 59 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2015 --> Mar 2016
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New P1 trial, Nontuberculous mycobacteria: Phase I Trial of DAR-901 (clinicaltrials.gov) - Feb 12, 2014
P1, N=77, Recruiting,
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