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| Name | Class |
|---|---|
| National University of Singapore | OTHER |
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Reduxium is a dietary supplement that provides immune support. This natural compound is orally-ingested in the form of droplets in water to boost the immune system and control inflammation. There is not enough data on the mechanism associated with the action of Reduxium or the extent of the immune response increase it produces. In this study, the investigators propose treating a group of healthy volunteers with Reduxium and investigate the utility of this approach in boosting the native and adaptive immune responses that correlate with immune protection. This may form the basis for a future study employing the product in infectious disease patients.
With the global population increasingly exposed to pandemic crises, permanent and expedient solutions are needed at an affordable cost. Vaccination is less than ideal as the virus is prone to a mutation that renders the previous generation of vaccine less effective. Epidemic and pandemic of viruses infection has become more common and affects both developed and less developed communities. Overcrowding and poor hygiene have been cited to be the major factors in these epidemics, but the host immune system and the ability of the human system to ward off virus infection is a factor less mentioned.
Nutrition is a critical determinant of immune responses and malnutrition the most common cause of immunodeficiency worldwide. Protein-energy malnutrition is associated with a significant impairment of cell-mediated immunity, phagocyte function, complement system, secretory immunoglobulin A antibody concentrations, and cytokine production. Deficiency of single nutrients also results in altered immune responses: this is observed even when the deficiency state is relatively mild. Of the micronutrients, zinc; selenium; iron; copper; vitamins A, C, E, and B6; and folic acid have important influences on immune responses. Adequate intake of vitamins B6, folate, B12, C, E, and of selenium, zinc, copper, and iron supports a T helper cell (Th)1 cytokine-mediated immune response with sufficient production of proinflammatory cytokines, which maintains an effective immune response and avoids a shift to an anti-inflammatory Th2 cell-mediated immune response and an increased risk of extracellular infections. Supplementation with these micronutrients reverses the Th2 cell-mediated immune response to a proinflammatory Th1 cytokine-regulated response with enhanced innate immunity.
Reduxium, a dietary supplement that provides immune support, is a low-cost candidate to boost immune response. Reduxium is a natural compound commercialised in the USA that helps restore homeostasis and controls inflammation. As no toxins or allergens are used, but purely food grade compounds, it is classified as a dietary supplement. Its current purpose is not to treat, diagnose, prevent or cure any disease, but it has immunomodulatory properties. Reduxium is manufactured using a proprietary reactor - a "biochemical cavitation mixer" that allows to create a "smart small molecule". The principal device belongs to the cavitation technology family and is used for the intensification of technological processes in liquid media (liquid processing, splitting of complex molecules, "cold" pasteurization, destruction of solid inclusions). The usage of this process technology enables compression of a set of molecules to 1/12th their original size. Its components are: Phosphoric Acid (58%), Microelement Complex (33.6%) (Zinc, Copper, Iron Pyrophosphate, Potassium, Calcium, Silica, Glycyrrhizic Acid (8.4%). The Microelement Complex is made up of a homogenized complex with special indication, pH =0.0008-0.4, waterless in the final composition.The complex molecules generated scan at the cellular level for the presence of pathogenic (bacterial, viral, fungal) etiologies by reading the characteristics of the electron proton (KNa) pump on the membrane. If these characteristics are violated, the supplement "enters" the cell. At the intra-cellular level, the supplement scans the cell in search of pathology; this "scanning process" is made on the basis of selectivity (healthy - do not touch/ill - induce apoptosis) through the mechanism of mitochondria activity. Specifically, the complex molecules start a cascade of biochemical processes (switching to mitochondria aerobic oxidation, restarting the methyl group with the "epigenetic" effects on DNA, apoptosis). It is unclear how and to which extent this mechanism contributes to innate immune activation following cellular damage and stress, or how it contributes to the adaptive immune response of T and B cells. The primary objective is to analyse the changes in the immune responses after two weeks of Reduxium intake.The secondary objective is to analyse the safety and tolerability of Reduxium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduxium | Experimental | 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduxium | Dietary Supplement | Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
| Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
| Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Blood tests of monocytes subsets utilising groups of labelled antibodies | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
| Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Blood tests of NK cell subsets utilising groups of labelled antibodies | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
| Renal Panel (Sodium) After 2 Weeks of Reduxium Intake | Sodium blood tests | Baseline and week 8 post-baseline |
| Renal Panel (Potassium) After 2 Weeks of Reduxium Intake | Potassium blood tests | Baseline and week 8 post-baseline |
| Renal Panel (Urea) After 2 Weeks of Reduxium Intake |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events After Reduxium Intake | To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore - The N.1 Institute for Health | Singapore | 117456 | Singapore | |||
| National University of Singapore - Yong Loo Lin School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9250133 | Background | Chandra RK. Nutrition and the immune system: an introduction. Am J Clin Nutr. 1997 Aug;66(2):460S-463S. doi: 10.1093/ajcn/66.2.460S. | |
| 17726308 | Background | Wintergerst ES, Maggini S, Hornig DH. Contribution of selected vitamins and trace elements to immune function. Ann Nutr Metab. 2007;51(4):301-23. doi: 10.1159/000107673. Epub 2007 Aug 28. |
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There is no plan to make IPD available
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Recruitment happened between October 7, 2020 and January 27, 2021 at National University Hospital (NUH) in Singapore.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reduxium | 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reduxium | The intervention consists of 1 oral drop of Reduxium (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immune T Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Blood tests of T cell subsets and phenotypes utilising groups of labelled antibodies | Posted | Mean | Standard Deviation | percentage of cells | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reduxium | 1 oral drop (0.05ml) per 10kg of body weight (max 8 drops), every 8 hours (3 times a day) for 14 days Reduxium: Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study administrator | NUS | +65 6601 7766 | lsixtc@nus.edu.sg |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2020 | May 25, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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single-centre, one-arm, prospective study
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Urea blood tests
| Baseline and week 8 post-baseline |
| Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake | Creatinine blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake | AST blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake | ALT blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Albumin) After 2 Weeks of Reduxium Intake | Albumin blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake | ALP blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake | Bilirubin blood tests | Baseline and week 8 post-baseline |
| Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake | LDH blood tests | Baseline and week 8 post-baseline |
| Singapore |
| 117597 |
| Singapore |
| National University Hospital | Singapore | 119074 | Singapore |
| 12955652 | Background | Cui W, Fan Y, Wu W, Zhang F, Wang JY, Ni AP. Expression of lymphocytes and lymphocyte subsets in patients with severe acute respiratory syndrome. Clin Infect Dis. 2003 Sep 15;37(6):857-9. doi: 10.1086/378587. Epub 2003 Aug 28. |
| 14767818 | Background | Li T, Qiu Z, Zhang L, Han Y, He W, Liu Z, Ma X, Fan H, Lu W, Xie J, Wang H, Deng G, Wang A. Significant changes of peripheral T lymphocyte subsets in patients with severe acute respiratory syndrome. J Infect Dis. 2004 Feb 15;189(4):648-51. doi: 10.1086/381535. Epub 2004 Feb 4. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Immune B Cell Subsets and Immunophenotype After 2 Weeks of Reduxium Intake | Blood tests of B cell subsets and phenotypes utilising groups of labelled antibodies | healthy participants | Posted | Mean | Standard Deviation | percentage of cells | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
|
|
|
| Primary | Innate Immune Cell Subsets (Monocytes -Cluster of Differentiation 14 R-Phycoerythrin (CD14PE)) After 2 Weeks of Reduxium Intake | Blood tests of monocytes subsets utilising groups of labelled antibodies | Posted | Mean | Standard Deviation | percentage of cells | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
|
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| Primary | Innate Immune Cell Subsets [Natural Killer (NK) Cells (CD56 Allophycocyanin (APC)] After 2 Weeks of Reduxium Intake | Blood tests of NK cell subsets utilising groups of labelled antibodies | healthy participants. | Posted | Mean | Standard Deviation | percentage of cells | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
|
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| Primary | Renal Panel (Sodium) After 2 Weeks of Reduxium Intake | Sodium blood tests | Posted | Mean | Standard Deviation | mmol/L | Baseline and week 8 post-baseline |
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| Primary | Renal Panel (Potassium) After 2 Weeks of Reduxium Intake | Potassium blood tests | Posted | Mean | Standard Deviation | mmol/L | Baseline and week 8 post-baseline |
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| Primary | Renal Panel (Urea) After 2 Weeks of Reduxium Intake | Urea blood tests | Posted | Mean | Standard Deviation | mmol/L | Baseline and week 8 post-baseline |
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| Primary | Renal Panel (Creatinine) After 2 Weeks of Reduxium Intake | Creatinine blood tests | Posted | Mean | Standard Deviation | umol/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Aspartate Aminotransferase (AST)) After 2 Weeks of Reduxium Intake | AST blood tests | Posted | Mean | Standard Deviation | U/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Alanine Aminotransferase (ALT)) After 2 Weeks of Reduxium Intake | ALT blood tests | Posted | Mean | Standard Deviation | U/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Albumin) After 2 Weeks of Reduxium Intake | Albumin blood tests | Posted | Mean | Standard Deviation | g/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Alkaline Phosphatase (ALP)) After 2 Weeks of Reduxium Intake | ALP blood tests | Posted | Mean | Standard Deviation | U/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Bilirubin) After 2 Weeks of Reduxium Intake | Bilirubin blood tests | Posted | Mean | Standard Deviation | umol/L | Baseline and week 8 post-baseline |
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| Primary | Liver Panel (Lactate Dehydrogenase (LDH)) After 2 Weeks of Reduxium Intake | LDH blood tests | Posted | Mean | Standard Deviation | U/L | Baseline and week 8 post-baseline |
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| Secondary | Number of Adverse Events After Reduxium Intake | To analyse the safety and tolerability of Reduxium after 2 weeks of Reduxium intake, based on number of adverse events | Posted | Number | adverse events | Baseline and weeks 3, 4, 5, 6, 7 and 8 post-baseline |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Title | Measurements |
|---|---|
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| Week 5 - Total B cells |
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| Week 6 - Total B cells |
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| Week 7 - Total B cells |
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| Week 8 - Total B cells |
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| Baseline - Memory B cells (MBCs) |
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| Week 3 - Memory B cells (MBCs) |
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| Week 4 - Memory B cells (MBCs) |
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| Week 5 - Memory B cells (MBCs) |
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| Week 6 - Memory B cells (MBCs) |
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| Week 7 - Memory B cells (MBCs) |
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| Week 8 - Memory B cells (MBCs) |
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| Baseline - Classical MBCs |
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| Week 3 - Classical MBCs |
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| Week 4 - Classical MBCs |
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| Week 5 - Classical MBCs |
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| Week 6 - Classical MBCs |
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| Week 7 - Classical MBCs |
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| Week 8 - Classical MBCs |
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| Baseline - Activated MBCs |
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| Week 3 - Activated MBCs |
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| Week 4 - Activated MBCs |
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| Week 5 - Activated MBCs |
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| Week 6 - Activated MBCs |
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| Week 7 - Activated MBCs |
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| Week 8 - Activated MBCs |
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| Baseline - Tissue-like MBCs |
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| Week 3 - Tissue-like MBCs |
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| Week 4 - Tissue-like MBCs |
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| Week 5 - Tissue-like MBCs |
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| Week 6 - Tissue-like MBCs |
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| Week 7 - Tissue-like MBCs |
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| Week 8 - Tissue-like MBCs |
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| Baseline - Switched B cells |
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| Week 3 - Switched B cells |
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| Week 4 - Switched B cells |
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| Week 5 - Switched B cells |
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| Week 6 - Switched B cells |
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| Week 7 - Switched B cells |
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| Week 8 - Switched B cells |
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| Baseline - Unswitched B cells |
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| Week 3 - Unswitched B cells |
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| Week 4 - Unswitched B cells |
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| Week 5 - Unswitched B cells |
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| Week 6 - Unswitched B cells |
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| Week 7 - Unswitched B cells |
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| Week 8 - Unswitched B cells |
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| Baseline - Naïve B cells |
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| Week 3 - Naïve B cells |
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| Week 4 - Naïve B cells |
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| Week 5 - Naïve B cells |
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| Week 6 - Naïve B cells |
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| Week 7 - Naïve B cells |
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| Week 8 - Naïve B cells |
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| Baseline - Plasmablasts |
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| Week 3 - Plasmablasts |
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| Week 4 - Plasmablasts |
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| Week 5 - Plasmablasts |
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| Week 6 - Plasmablasts |
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| Week 7 - Plasmablasts |
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| Week 8 - Plasmablasts |
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| Baseline - Exhausted B cells |
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| Week 3 - Exhausted B cells |
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| Week 4 - Exhausted B cells |
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| Week 5 - Exhausted B cells |
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| Week 6 - Exhausted B cells |
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| Week 7 - Exhausted B cells |
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| Week 8 - Exhausted B cells |
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| Week 5 - Non-classical monocytes |
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| Week 6 - Non-classical monocytes |
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| Week 7 - Non-classical monocytes |
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| Week 8 - Non-classical monocytes |
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| Baseline - Intermediate monocytes |
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| Week 3 - Intermediate monocytes |
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| Week 4 - Intermediate monocytes |
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| Week 5 - Intermediate monocytes |
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| Week 6 - Intermediate monocytes |
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| Week 7 - Intermediate monocytes |
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| Week 8 - Intermediate monocytes |
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| Baseline - Classical monocytes |
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| Week 3 - Classical monocytes |
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| Week 4 - Classical monocytes |
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| Week 5 - Classical monocytes |
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| Week 6 - Classical monocytes |
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| Week 7 - Classical monocytes |
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| Week 8 - Classical monocytes |
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| Title | Measurements |
|---|---|
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| Week 5 - CD16++CD56- |
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| Week 6 - CD16++CD56- |
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| Week 7 - CD16++CD56- |
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| Week 8 - CD16++CD56- |
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| Baseline - CD16+CD56+ |
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| Week 3 - CD16+CD56+ |
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| Week 4 - CD16+CD56+ |
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| Week 5 - CD16+CD56+ |
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| Week 6 - CD16+CD56+ |
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| Week 7 - CD16+CD56+ |
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| Week 8 - CD16+CD56+ |
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| Baseline - CD16+CD56++ |
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| Week 3 - CD16+CD56++ |
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| Week 4 - CD16+CD56++ |
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| Week 5 - CD16+CD56++ |
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| Week 6 - CD16+CD56++ |
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| Week 7 - CD16+CD56++ |
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| Week 8 - CD16+CD56++ |
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| Baseline - CD16-CD56+ |
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| Week 3 - CD16-CD56+ |
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| Week 4 - CD16-CD56+ |
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| Week 5 - CD16-CD56+ |
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| Week 6 - CD16-CD56+ |
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| Week 7 - CD16-CD56+ |
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| Week 8 - CD16-CD56+ |
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| Baseline - CD16-CD56++ |
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| Week 3 - CD16-CD56++ |
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| Week 4 - CD16-CD56++ |
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| Week 5 - CD16-CD56++ |
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| Week 6 - CD16-CD56++ |
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| Week 7 - CD16-CD56++ |
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| Week 8 - CD16-CD56++ |
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