| 1 |
NCT ID |
NCT06257212 |
| Title |
Live Vaccines and Innate Immunity Training in COPD |
| Dates |
2024/02/28 to 2025/09 |
| Phase |
Phase 4 |
| Enrolment |
60 (Estimated) |
| Condition(s) |
COPD |
| Intervention(s) |
BCG vaccine
MMR vaccine |
| Primary Outcome |
Innate immune training measured by fold-changes in cytokine production capacity of innate immune cells following pro-inflammatory stimulation. Measured from inclusion in the trial to 4 months’ post-inclusion. Cytokines include: IL-1β, IL-10, TNF-α, IFN-γ |
| 2 |
NCT ID |
NCT06266754 |
| Title |
The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau |
| Dates |
2024/01/29 to 2024/12/31 |
| Phase |
Phase 4 |
| Enrolment |
80 (Estimated) |
| Condition(s) |
Vaccine Reaction |
| Intervention(s) |
Oral Polio vaccine |
| Primary Outcome |
-
Levels of proinflammatory cytokines (including IL1-β, TNF-α, IFN-γ) after stimulation of PBMCs with non-OPV antigens and mitogens 1 month after intervention
-
Levels of plasma markers of systemic inflammation (e.g. TWEAK and SIRT2) 1 month after intervention
-
Investigating epigenetic changes in PBMCs by single-cell ATAC-sequencing and whole-genome methylation assays 1 month after intervention
-
Investigate transcriptional effects on immune cells by single-cell RNA-sequencing 1 month after intervention. Identifying proportions of immune cell subsets
|
| 3 |
NCT ID |
NCT05208060 |
| Title |
Study to Evaluate the Ability of Sublingual MV130 to Induce the Expression of Trained Immunity in Peripheral Blood Cells |
| Dates |
2023/09/01 to 2025/12/31 |
| Phase |
Phases 1 and 2 |
| Enrolment |
48 (Estimated) |
| Condition(s) |
Immune Response |
| Intervention(s) |
MV130 vaccine |
| Primary Outcome |
Increase in ex vivo PBMCs cytokine response (TNF-α, IL-6, IL-1β) to secondary restimulation compared to placebo at days 15, 45, and 70 with respect to baseline |
| Selected Secondary Outcomes relevant to Trained Immunity |
-
Epigenetic and metabolic changes in purified monocytes from PBMCs, including specific Trained Immunity-associated miRNAs (miR155, miR146, miR21), lactate production, glucose consumption, and mitochondrial activity at day 45 with respect to baseline
-
Change in proportions of immune cells (including T cells, B cells, NK cells, and subsets of monocytes) in peripheral blood at days 15, 45, and 70 with respect to baseline
|
| 4 |
NCT ID |
NCT02403505 |
| Title |
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer |
| Dates |
2021/12/28 to 2025/02/28 |
| Phase |
Phase 1 |
| Enrolment |
20 (Estimated) |
| Condition(s) |
Rectal Cancer |
| Intervention(s) |
CEA protein antigen and BCG vaccine mix for percutaneous use |
| Primary Outcome |
Timeframe: up to 90 days
-
Participants with positive CEA blood test
-
Participants with positive IGRA blood test with CEA protein antigen after percutaneous use
-
Participants with IGRA blood test with TB antigens (negative before percutaneous use, positive after percutaneous use)
|
| 5 |
NCT ID |
NCT05507671 |
| Title |
The Role of BCG Vaccine in the Clinical Evolution of COVID-19 and in the Efficacy of Anti-SARS-CoV-2 Vaccines |
| Dates |
2021/05/27 to 2023/12/31 |
| Phase |
Phase 3 |
| Enrolment |
556 (Estimated) |
| Condition(s) |
COVID-19 |
| Intervention(s) |
BCG vaccine |
| Primary Outcome |
-
Incidence of SARS-CoV-2 infection. Timeframe: 6 months from recruitment day
-
Incidence of COVID-19 symptoms. Timeframe: 6 months from recruitment day
-
Intensity of efficacy of first dose of vaccine against COVID-19. Timeframe: 6 months from recruitment day
-
Duration of efficacy of the second vaccine dose against COVID-19. Timeframe: 1 year from recruitment day
|
| Selected Secondary Outcomes relevant to Trained Immunity |
Serum concentrations of cytokines TNF-α, IFN-γ, IL-1β, IL-4, IL-6, and IL-10 in 50 participants of BCG group versus 50 participants of placebo group 2 months after recruitment |
| 6 |
NCT ID |
NCT06628544 |
| Title |
Trained Immunity in Fungal Infection and Its Mechanism |
| Dates |
2020/09/01 to 2023/12/01 |
| Phase |
Early Phase 1 |
| Enrolment |
79 (Actual) |
| Condition(s) |
BCG vaccination |
| Intervention(s) |
BCG vaccine
Metformin |
| Primary Outcome |
IL-6 and TNF-α cytokine production by PBMCs isolated after 5 days of continuous medication and restimulated with C. albicans or Mycobacterium tuberculosis |
| 7 |
NCT ID |
NCT03296423 |
| Title |
Bacillus Calmette-Guérin Vaccination to Prevent Infections of the Elderly |
| Dates |
2017/09/21 to 2020/11/30 |
| Phase |
Phase 4 |
| Enrollment |
200 (Actual) |
| Condition(s) |
Infection
Hospitalization
Mortality |
| Intervention(s) |
BCG vaccine |
| Primary Outcome |
Time to first infection. Timeframe: 12 months |
| Selected Secondary Outcomes relevant to Trained Immunity |
-
Cytokine stimulation from PBMCs. Timeframe: month 3
-
Epigenetic changes of circulating monocytes. Timeframe: month 3
|
| 8 |
NCT ID |
NCT02114255 |
| Title |
Effects of BCG on Influenza Induced Immune Response |
| Dates |
2014/05 to 2014/09 |
| Phase |
Phases 2 and 3 |
| Enrolment |
40 (Actual) |
| Condition(s) |
Influenza virus infection
Trained Immunity |
| Intervention(s) |
BCG vaccine |
| Primary Outcome |
-
Difference in influenza antibody titers at days 14, 21, 28, and 42
-
Difference in thrombocyte function at days 0, 14, 21, 28, and 42
|
| Selected Secondary Outcomes relevant to Trained Immunity |
-
IFN-γ, IL-10, type 1 IFN, IL-17, IL-22 production by ex vivo leukocytes stimulated with inactivated/live influenza virus at days 0, 14, 28, and 42
-
Production of inflammatory mediators (including TNFα, IL-1β, IFN-γ, IL-10, IL-17, and IL-22) by ex vivo leukocytes stimulated with different stimuli (including M. tuberculosis, S. aureus, C. albicans, and inactivated influenza) at days 0, 21, 28, and 42
-
qPCR/microarray of inflammatory transcriptional pathways at days 0, 14, 21, 28, and 42.
-
Granzyme B production by ex vivo leukocytes stimulated with inactivated/live influenza virus at days 0, 14, 21, 28, and 42
|
| 9 |
NCT ID |
NCT01734811 |
| Title |
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130) |
| Dates |
2012/10 to 2017/02 |
| Phase |
Phase 3 |
| Enrolment |
120 (Actual) |
| Condition(s) |
Bronchospasm
Bronchiolitis
Bronchitis |
| Intervention(s) |
MV130 vaccine |
| Primary Outcome |
Number of Recurrent Bronchospasm (Wheezing Attacks) |
| (b) Trials investigating modulation of Trained Immunity for therapeutic benefit |
| 10 |
NCT ID |
NCT06624436 |
| Title |
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia |
| Dates |
2024/10/24 to 2025/12 |
| Phase |
Phase 4 |
| Enrolment |
52 (Estimated) |
| Condition(s) |
Sepsis
Neuroinflammatory Response
Immunosuppression
Endotoxemia |
| Intervention(s) |
Dexamethasone
Tocilizumab
Anakinra |
| Primary Outcome |
-
Plasma TNF concentrations upon second LPS challenge
-
Cerebrospinal fluid TNF concentrations during repeated experimental human endotoxemia
|
| Selected Secondary Outcomes relevant to Trained Immunity |
-
Plasma cytokine (IL1RA, IL-6, IL-8, IL-10, MIP-1α, MIP-1β, MCP-1, G-CSF, IP-10, CX3CL1, YKL-40) concentrations (plasma and cerebrospinal fluid), other inflammatory protein biomarkers (Olink Target 96 inflammation panel) (plasma and cerebrospinal fluid), and mHLA-DR during first and second LPS challenges
-
Blood leukocyte single-cell and bulk mRNA profiles/transcriptomic pathways upon LPS challenges
-
Cytokine production of ex vivo leukocyte cultures
|
| 11 |
NCT ID |
NCT03332225 |
| Title |
A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis |
| Dates |
2017/12/15 to 2019/12/31 |
| Phase |
Phase 2 |
| Enrolment |
36 (Actual) |
| Condition(s) |
Sepsis
Macrophage Activation Syndrome |
| Intervention(s) |
Anakinra
Recombinant human IFN-γ |
| Primary Outcome |
Mortality. Timeframe: 28 days |
| Selected Secondary Outcomes relevant to Trained Immunity |
-
Cytokine stimulation from PBMCs. Timeframe: 4 and 7 days
-
Gene expression of PBMCs. Timeframe: 7 days
-
Epigenetic changes of circulating monocytes. Timeframe: 7 days
|
| (c) Trials investigating inhibition of Trained Immunity for therapeutic benefit |
| 12 |
NCT ID |
NCT05790499 |
| Title |
LDL-c Level Variability and Trained Immunity |
| Dates |
2023/03/20 to 2024/01/31 |
| Phase |
N/A |
| Enrollment |
12 (Estimated) |
| Condition(s) |
Cholesterol Variability
Trained Immunity |
| Intervention(s) |
Atorvastatin |
| Primary Outcome |
Changes in LDL-C levels between baseline and atorvastatin treatment cycles. Timeframe: 16 weeks |
| Selected Secondary Outcomes relevant to Trained Immunity |
Timeframe: 16 weeks
-
PBMCs subgroup percentage and activation status
-
PBMCs secreting cytokines
-
PBMCs change in gene expression
-
Levels of hs-CRP, IL-6, IL-18, and sVCAM-1
|
| 13 |
NCT ID |
NCT05210725 |
| Title |
Trained Immunity by Dual-pathway Inhibition in Coronary Artery Disease |
| Dates |
2022/03/01 to 2022/07/01 |
| Phase |
Phase 4 |
| Enrolment |
20 (Actual) |
| Condition(s) |
Coronary Artery Disease |
| Intervention(s) |
Rivaroxaban and Acetylsalicylic acid |
| Primary Outcome |
Whole blood immune responsiveness to LPS stimulation when switching from acetylsalicylic acid monotherapy to acetylsalicylic acid and low-dose rivaroxaban dual pathway inhibition. Timeframe: 12 weeks |
| Selected trial outcomes relevant to Trained Immunity |
-
White blood cell count and distribution. Timeframe: 3 months
-
Monocyte immune responsiveness to LPS stimulation. Timeframe: 3 months
-
Enrichment of epigenetic gene marks. Timeframe: 3 months
|
