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| Name | Class |
|---|---|
| George Washington University | OTHER |
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Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG 10104, a Toll-like Receptor-9 agonist.
This is a Phase 1 randomized double-blind dose-escalation clinical trial in healthy hookworm-naïve adults conducted at the George Washington Medical Faculty Associates, Washington, DC, and the George Washington University School of Medicine and Health Sciences, Department of Microbiology, Immunology and Tropical Medicine, Washington, DC. In total, 24 subjects will be progressively enrolled into 2 cohorts of 12 subjects each. In the first cohort 8 subjects will receive 30µg Na-GST-1/Alhydrogel co-administered with 500µg CpG 10104 and 4 subjects will receive 100µg Na-GST-1/Alhydrogel® only, in a randomized, double-blinded fashion. In the second cohort 8 subjects will receive 100µg Na-GST-1/Alhydrogel co-administered with 500µg CpG 10104 and 4 volunteers will receive 100µg Na-GST-1/Alhydrogel only, in a randomized, double-blinded fashion. Vaccinations will be administered intramuscularly in the deltoid muscle according to a 0, 2, 4-month schedule. Each subject will participate in the study for 68 weeks (16 months) and the total duration of the study is estimated at approximately 19 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 µg Na-GST-1/Alhydrogel | Experimental | High Dose Na-GST-1/Alhydrogel® Only |
|
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 | Experimental | Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 |
|
| 100 µg Na-GST-1/Alhydrogel + CpG 10104 | Experimental | High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Na-GST-1/Alhydrogel® | Biological | The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine-related Adverse Events | The frequency of immediate, systemic, and local injection site adverse events, graded by severity, for Na-GST-1/Alhydrogel administered alone or in combination with CpG 10104 | Up to study day 470 |
| Measure | Description | Time Frame |
|---|---|---|
| IgG Antibody Response to Na-GST-1 on Study Day 126 | Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by a qualified indirect enzyme-linked immunosorbent assay (ELISA) and measured in Arbitrary Units (AU) that are interpolated from a standard reference curve formulated by serial dilutions of a serum pool derived from known high responders in previous clinical trials of this antigen. This ELISA has not been validated and does not report mass units since these have not yet been defined. Reporting ELISA values in AU is an accepted practice early in clinical development before full assay validation and quantification of mass units. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Diemert, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20036 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 µg Na-GST-1/Alhydrogel | High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. |
| FG001 | 30 µg Na-GST-1/Alhydrogel + CpG 10104 | Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
| FG002 | 100 µg Na-GST-1/Alhydrogel + CpG 10104 | High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 µg Na-GST-1/Alhydrogel | High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Vaccine-related Adverse Events | The frequency of immediate, systemic, and local injection site adverse events, graded by severity, for Na-GST-1/Alhydrogel administered alone or in combination with CpG 10104 | Posted | Count of Participants | Participants | Up to study day 470 |
|
Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
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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 | 100 µg Na-GST-1/Alhydrogel | High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Diemert, MD | George Washington University | 202-994-2909 | ddiemert@gwu.edu |
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| ID | Term |
|---|---|
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| D018798 | Anemia, Iron-Deficiency |
| D058069 | Neglected Diseases |
| ID | Term |
|---|---|
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C408982 | CPG-oligonucleotide |
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|
|
| CpG 10104 | Biological | Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
|
|
| 14 days after final vaccination |
| Exploratory Cellular Immune Response to Na-GST-1 | Exploratory studies of the cellular immune responses to the Na-GST-1 antigen both before and after immunization. | Up to study day 290 |
| BG001 | 30 µg Na-GST-1/Alhydrogel + CpG 10104 | Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
| BG002 | 100 µg Na-GST-1/Alhydrogel + CpG 10104 | High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 |
Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
| OG002 | 100 µg Na-GST-1/Alhydrogel + CpG 10104 | High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. |
|
|
| Secondary | IgG Antibody Response to Na-GST-1 on Study Day 126 | Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by a qualified indirect enzyme-linked immunosorbent assay (ELISA) and measured in Arbitrary Units (AU) that are interpolated from a standard reference curve formulated by serial dilutions of a serum pool derived from known high responders in previous clinical trials of this antigen. This ELISA has not been validated and does not report mass units since these have not yet been defined. Reporting ELISA values in AU is an accepted practice early in clinical development before full assay validation and quantification of mass units. | Posted | Geometric Mean | 95% Confidence Interval | Arbitrary Units/mL | 14 days after final vaccination |
|
|
|
| Secondary | Exploratory Cellular Immune Response to Na-GST-1 | Exploratory studies of the cellular immune responses to the Na-GST-1 antigen both before and after immunization. | The data for this endpoint were not collected since PBMC samples were not sent from the clinical trial site in Africa to the testing laboratory in the US due to the ending of the grant funding the study and a lack of funding to ship the samples. This endpoint will not be completed. | Posted | Up to study day 290 |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | 30 µg Na-GST-1/Alhydrogel + CpG 10104 | Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | 100 µg Na-GST-1/Alhydrogel + CpG 10104 | High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'. | 0 | 8 | 0 | 8 | 8 | 8 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Antinuclear antibody increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diastolic hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA (15.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Hangover | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site coldness | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Otitis media chronic | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Systolic hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Vaginitis bacterial | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
Not provided
Not provided
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |