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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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This is a Phase I/IIa, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccine delivered by electroporation (EP) to participants with human papilloma virus (HPV) associated head and neck squamous cell cancer (HNSCC).
This is a Phase I/IIa, open-label, study to evaluate the safety, tolerability, and immunogenicity of INO-3112 [6 mg of VGX-3100 (2 separate DNA plasmids respectively encoding E6 and E7 proteins of HPV 16 and HPV 18) and 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12)] delivered by electroporation (EP) in up to 25 (twenty-five) participants with HPV positive head and neck cancer. The immunotherapy was studied in the following two groups of participants:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Surgery Cohort | Other | Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device. |
|
| Cohort 2: Chemoradiation | Other | Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-3112 | Biological | 1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered intramuscularly (IM) followed immediately by electroporation (EP) with CELLECTRA™-5P device for a total of 4 doses of immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs) | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. TEAE is defined as any AE with onset after the administration of study medication through the end-of-study follow-up, or any event that was present at baseline but worsened in intensity or was subsequently considered treatment-related by the Investigator through the end of the study. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life-threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful or requires inpatient hospitalization or prolongation of existing hospitalization. | Up to 6 months post last dose |
| Measure | Description | Time Frame |
|---|---|---|
| E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA. | Up to 6 months post last dose |
| E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA |
Not provided
Inclusion Criteria:
Signed and dated written Ethics Committee approved informed consent.
Age ≥18 years.
Histologically confirmed HPV-positive (as assessed by p16 IHC or oncogenic HPV ISH or PCR) mucosal squamous cell head and neck cancer:
Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), (Aspartate Aminotransferase) AST, (Alanine Aminotransferase) ALT within 2.5x institutional ULN, (Creatine Phosphokinase) CPK within 2.5 x ULN.
ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Skolnik, MD | Inovio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23052295 | Background | Bagarazzi ML, Yan J, Morrow MP, Shen X, Parker RL, Lee JC, Giffear M, Pankhong P, Khan AS, Broderick KE, Knott C, Lin F, Boyer JD, Draghia-Akli R, White CJ, Kim JJ, Weiner DB, Sardesai NY. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med. 2012 Oct 10;4(155):155ra138. doi: 10.1126/scitranslmed.3004414. | |
| 24051434 |
| Label | URL |
|---|---|
| Sponsor's Website | View source |
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Participants with a diagnosis of HPV associated head and neck squamous cell carcinoma were enrolled in the study between 13th August 2014 to 23rd January 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Surgery Cohort | Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device. |
| FG001 | Cohort 2: Chemoradiation | Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least one dose of study treatment plus EP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Surgery Cohort | Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device. |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Event (SAEs) | An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. TEAE is defined as any AE with onset after the administration of study medication through the end-of-study follow-up, or any event that was present at baseline but worsened in intensity or was subsequently considered treatment-related by the Investigator through the end of the study. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life-threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful or requires inpatient hospitalization or prolongation of existing hospitalization. | Safety population included all participants who received at least one dose of study treatment plus EP. | Posted | Count of Participants | Participants | Up to 6 months post last dose |
Up to 6 months post last dose
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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 | Cohort 1: Surgery Cohort | Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA Version 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 20.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Inovio Pharmaceuticals | 267-440-4237 | clinical.trials@inovio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2016 | Jan 4, 2021 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000657484 | MEDI0457 |
| C000604121 | VGX-3100 |
| C000722693 | rocakinogene sifuplasmid |
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|
| CELLECTRA™-5P | Device | CELLECTRA™-5P device was used for EP following IM delivery of INO-3112 for a total of 4 doses of immunotherapy. |
|
Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA. |
| Up to 6 months post last dose |
| Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot) | Baseline up to 6 months post last dose |
| Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry | A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38. | At baseline and Week 2 post last dose |
| Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry | A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38. | At baseline and Week 2 post last dose |
| Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) | The difference in means (post-surgery minus screening) for tumor-infiltrating lymphocytes (TILs) such as CD8, FoxP3, and perforin was analyzed using immunohistochemistry staining techniques. | At screening and post-surgery |
| Mean Difference in CD8/FoxP3 Ratio in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) | The difference in means (post-surgery minus screening) for the CD8/FoxP3 ratio was analyzed using immunohistochemistry staining techniques. | At screening and post-surgery |
| Phenotype of Cultured TILs | Up to 6 months post last dose |
| Diehl MC, Lee JC, Daniels SE, Tebas P, Khan AS, Giffear M, Sardesai NY, Bagarazzi ML. Tolerability of intramuscular and intradermal delivery by CELLECTRA((R)) adaptive constant current electroporation device in healthy volunteers. Hum Vaccin Immunother. 2013 Oct;9(10):2246-52. doi: 10.4161/hv.24702. Epub 2013 Jun 4. |
| Progression of Disease |
|
| BG001 |
| Cohort 2: Chemoradiation |
Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Cohort 1: Surgery Cohort | Participants received up to two doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart before surgery and up to three doses of INO-3112 immunotherapy 3 weeks (± 3 days) apart after surgery for a total of no more than four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device. |
| OG001 | Cohort 2: Chemoradiation | Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy. |
|
|
| Secondary | E6 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by Enzyme-linked Immunosorbent Assay (ELISA) | Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA. | Assigned Number of Doses (ANoD) population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point. | Posted | Mean | Standard Deviation | log titer | Up to 6 months post last dose |
|
|
|
| Secondary | E7 Antigen Specific Anti-HPV-16/18 Antibody Titers Assessed by ELISA | Titers for HPV-16 and HPV-18 E6- and E7-specific antibodies were assessed by ELISA. | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point. | Posted | Mean | Standard Deviation | log titer | Up to 6 months post last dose |
|
|
|
| Secondary | Change From Baseline (CFB) in Combined HPV-16 and HPV-18 E6 and E7 Antigen-Specific Spot-Forming Units Per Million Peripheral Blood Mononuclear Cell (SFU/10^6 PBMC) as Assessed by Enzyme-Linked Immunosorbent Spot-Forming Assay (ELISpot) | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point. | Posted | Mean | Standard Deviation | SFU/10^6 PBMC | Baseline up to 6 months post last dose |
|
|
|
| Secondary | Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-16 as Assessed by Flow Cytometry | A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38. | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point. | Posted | Mean | Standard Deviation | cells/million T-cells | At baseline and Week 2 post last dose |
|
|
|
| Secondary | Change From Baseline (CFB) in CD8+ T-Cell Responses Specific for HPV-18 as Assessed by Flow Cytometry | A flow cytometry assay called "lytic granule loading" was used to analyze CD8+ T cells specific for HPV-16 and CD8+ T cells specific for HPV-18 by evaluating the following markers: CD8, granzyme A (GrzA), granzyme B (GrzB), and perforin (Prf) co-expression with CD137, CD69, or CD38. | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. Number analyzed is the number of participants with data available for analysis at a specified time-point. | Posted | Mean | Standard Deviation | cells/million T-cells | At baseline and Week 2 post last dose |
|
|
|
| Secondary | Mean Difference in Tumor Infiltrating Lymphocytes (TILs) in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) | The difference in means (post-surgery minus screening) for tumor-infiltrating lymphocytes (TILs) such as CD8, FoxP3, and perforin was analyzed using immunohistochemistry staining techniques. | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. | Posted | Mean | 95% Confidence Interval | positive cells per square millimeter | At screening and post-surgery |
|
|
|
| Secondary | Mean Difference in CD8/FoxP3 Ratio in Presurgical and Surgical Tumor Tissue Samples of Cohort I as Assessed by Immunohistochemistry (IHC) | The difference in means (post-surgery minus screening) for the CD8/FoxP3 ratio was analyzed using immunohistochemistry staining techniques. | ANoD population included all participants who received their assigned number of doses of study treatment plus EP. | Posted | Mean | 95% Confidence Interval | ratio | At screening and post-surgery |
|
|
|
| Secondary | Phenotype of Cultured TILs | Data was not collected due to lack of recoverable samples sufficient for analysis | Posted | Up to 6 months post last dose |
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | Cohort 2: Chemoradiation | Participants received four doses of INO-3112 immunotherapy delivered IM followed by EP with CELLECTRA™-5P device 3 weeks (± 3 days) apart beginning approximately 2 to 6 months after chemoradiation therapy. | 0 | 16 | 0 | 16 | 15 | 16 |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Thyroiditis | Endocrine disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Retinal Detachment | Eye disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypoaesthesia Oral | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Salivary Duct Inflammation | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Tongue Discolouration | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Tongue Oedema | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Localised Oedema | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA Version 20.0 | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Joint Range Of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Trigger Finger | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Restless Legs Syndrome | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pharyngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Alopecia Areata | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin Fibrosis | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Skin Neoplasm Excision | Surgical and medical procedures | MedDRA Version 20.0 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA Version 20.0 | Systematic Assessment |
|
Not provided
| HPV-16 ELISA titer, 2nd dose |
|
|
| HPV-16 ELISA titer, 3rd dose |
|
|
| HPV-16 ELISA titer, 4th dose |
|
|
| HPV-16 ELISA titer, Week 2 post last dose |
|
|
| HPV-16 ELISA titer, 1st long term follow-up |
|
|
| HPV-16 ELISA titer, 2nd long term follow-up |
|
|
| HPV-16 ELISA titer, 3rd long term follow-up |
|
|
| HPV-16 ELISA titer, 4th long term follow-up |
|
|
| HPV-16 ELISA titer, 5th long term follow-up |
|
|
| HPV-16 ELISA titer, 6th long term follow-up |
|
|
| HPV-16 ELISA titer, initial surgery |
|
|
| HPV-16 ELISA titer, surgery |
|
|
| HPV-16 ELISA titer, follow-up Week 2 post-surgery |
|
|
| HPV-16 ELISA titer, optional surgery |
|
|
| HPV-16 ELISA titer, unscheduled visit |
|
|
| HPV-16 ELISA titer, end of study follow-up |
|
|
| HPV-18 ELISA titer, 1st dose |
|
|
| HPV-18 ELISA titer, 2nd dose |
|
|
| HPV-18 ELISA titer, 3rd dose |
|
|
| HPV-18 ELISA titer, 4th dose |
|
|
| HPV-18 ELISA titer, Week 2 post last dose |
|
|
| HPV-18 ELISA titer, 1st long term follow-up |
|
|
| HPV-18 ELISA titer, 2nd long term follow-up |
|
|
| HPV-18 ELISA titer, 3rd long term follow-up |
|
|
| HPV-18 ELISA titer, 4th long term follow-up |
|
|
| HPV-18 ELISA titer, 5th long term follow-up |
|
|
| HPV-18 ELISA titer, 6th long term follow-up |
|
|
| HPV-18 ELISA titer, initial surgery |
|
|
| HPV-18 ELISA titer, surgery |
|
|
| HPV-18 ELISA titer, follow-up Week 2 post-surgery |
|
|
| HPV-18 ELISA titer, optional surgery |
|
|
| HPV-18 ELISA titer, unscheduled visit |
|
|
| HPV-18 ELISA titer, end of study follow-up |
|
|
| HPV-16 ELISA titer, 2nd dose |
|
|
| HPV-16 ELISA titer, 3rd dose |
|
|
| HPV-16 ELISA titer, 4th dose |
|
|
| HPV-16 ELISA titer, Week 2 post last dose |
|
|
| HPV-16 ELISA titer, 1st long term follow-up |
|
|
| HPV-16 ELISA titer, 2nd long term follow-up |
|
|
| HPV-16 ELISA titer, 3rd long term follow-up |
|
|
| HPV-16 ELISA titer, 4th long term follow-up |
|
|
| HPV-16 ELISA titer, 5th long term follow-up |
|
|
| HPV-16 ELISA titer, 6th long term follow-up |
|
|
| HPV-16 ELISA titer, initial surgery |
|
|
| HPV-16 ELISA titer, surgery |
|
|
| HPV-16 ELISA titer, follow-up Week 2 post-surgery |
|
|
| HPV-16 ELISA titer, optional surgery |
|
|
| HPV-16 ELISA titer, unscheduled visit |
|
|
| HPV-16 ELISA titer, end of study follow-up |
|
|
| HPV-18 ELISA titer, 1st dose |
|
|
| HPV-18 ELISA titer, 2nd dose |
|
|
| HPV-18 ELISA titer, 3rd dose |
|
|
| HPV-18 ELISA titer, 4th dose |
|
|
| HPV-18 ELISA titer, Week 2 post last dose |
|
|
| HPV-18 ELISA titer, 1st long term follow-up |
|
|
| HPV-18 ELISA titer, 2nd long term follow-up |
|
|
| HPV-18 ELISA titer, 3rd long term follow-up |
|
|
| HPV-18 ELISA titer, 4th long term follow-up |
|
|
| HPV-18 ELISA titer, 5th long term follow-up |
|
|
| HPV-18 ELISA titer, 6th long term follow-up |
|
|
| HPV-18 ELISA titer, initial surgery |
|
|
| HPV-18 ELISA titer, surgery |
|
|
| HPV-18 ELISA titer, follow-up Week 2 post-surgery |
|
|
| HPV-18 ELISA titer, optional surgery |
|
|
| HPV-18 ELISA titer, unscheduled visit |
|
|
| HPV-18 ELISA titer, end of study follow-up |
|
|
| CFB at 2nd dose |
|
|
| CFB at 3rd dose |
|
|
| CFB at 4th dose |
|
|
| CFB at Week 2 post last dose |
|
|
| CFB at 1st long term follow-up |
|
|
| CFB at 2nd long term follow-up |
|
|
| CFB at 3rd long term follow-up |
|
|
| CFB at 4th long term follow-up |
|
|
| CFB at 5th long term follow-up |
|
|
| CFB at 6th long term follow-up |
|
|
| CFB at follow-up Week 2 post-surgery |
|
|
| CFB at end of study follow-up |
|
|
| CD8+CD137+GrzA+GrzB+Prf+,CFB Week 2 post last dose |
|
|
| CD8+CD69+GrzA+GrzB+Prf+, baseline |
|
|
| CD8+CD69+GrzA+GrzB+Prf+, CFB Week 2 post last dose |
|
|
| CD8+CD38+GrzA+GrzB+Prf+, baseline |
|
|
| CD8+CD38+GrzA+GrzB+Prf+, CFB Week 2 post last dose |
|
|
| CD8+CD137+GrzA+GrzB+Prf+,CFB Week 2 post last dose |
|
|
| CD8+CD69+GrzA+GrzB+Prf+, baseline |
|
|
| CD8+CD69+GrzA+GrzB+Prf+, CFB Week 2 post last dose |
|
|
| CD8+CD38+GrzA+GrzB+Prf+, baseline |
|
|
| CD8+CD38+GrzA+GrzB+Prf+, CFB Week 2 post last dose |
|
|
| Title | Measurements |
|---|---|
|