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| ID | Type | Description | Link |
|---|---|---|---|
| 12061 | Registry Identifier | DAIDS-ES Registry Number |
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
This study will evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
Participants will be randomly assigned to one of four groups: Group 1 Treatment, Group 1 Control, Group 2 Treatment, or Group 2 Control.
Participants in Group 1 Treatment will receive p24CE1/2 pDNA and IL-12 pDNA at Day 0 and Month 1, then p24CE1/2 pDNA plus p55^gag pDNA and IL-12 pDNA at Months 3 and 6. Participants in Group 1 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6.
Participants in Group 2 Treatment will receive p55^gag pDNA and IL-12 pDNA at Day 0 and Months 1, 3, and 6. Participants in Group 2 Control will receive placebo (sodium chloride for injection) at Day 0 and Months 1, 3, and 6.
Study visits will occur at Day 0, Week 2, and Months 1, 1.25, 1.5, 3, 3.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations and clinical assessments, blood and urine collection, optional stool collection, HIV testing, risk reduction counseling, and interviews/questionnaires. At Month 18, study staff will contact participants for follow-up health monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Treatment): p24CE1/2 pDNA + p55^gag pDNA + IL-12 pDNA | Experimental | Participants will receive the p24CE1/2 pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Month 1. They will receive the p24CE1/2 pDNA vaccine plus the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Months 3 and 6. |
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| Group 1 (Control): Placebo | Placebo Comparator | Participants will receive placebo at Day 0 and Months 1, 3, and 6. |
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| Group 2 (Treatment): p55^gag pDNA + IL-12 pDNA | Experimental | Participants will receive the p55^gag pDNA vaccine and the IL-12 pDNA adjuvant at Day 0 and Months 1, 3, and 6. |
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| Group 2 (Control): Placebo | Placebo Comparator | Participants will receive placebo at Day 0 and Months 1, 3, and 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p24CE1/2 pDNA Vaccine | Biological | Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Measured through Month 0, 1, 3, 6 |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Measured through Month 0, 1, 3, 6 |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Measured through Month 0, 1, 3, 6 |
| Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, Days 14, 42, 98, 182 and 273 |
| Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population | Measured during screening, Days 14, 42, 98, 182 and 273 |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. |
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Inclusion Criteria:
General and Demographic Criteria
HIV-Related Criteria:
Laboratory Inclusion Values
Virology
Negative HIV-1 and -2 blood test: U.S. volunteers must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA).
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Normal urine:
Reproductive Status
Reproductive status: A volunteer who was born female must:
Exclusion Criteria:
General
Vaccines and other Injections
Immune System
Clinically significant medical conditions
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| Name | Affiliation | Role |
|---|---|---|
| Spyros Kalams | Vanderbilt University | Study Chair |
| Hyman Scott | Bridge HIV, SFDPH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridge HIV CRS | San Francisco | California | 94143 | United States | ||
| The Hope Clinic of the Emory Vaccine Center CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39088271 | Derived | Kalams SA, Felber BK, Mullins JI, Scott HM, Allen MA, De Rosa SC, Heptinstall J, Tomaras GD, Hu J, DeCamp AC, Rosati M, Bear J, Pensiero MN, Eldridge J, Egan MA, Hannaman D, McElrath MJ, Pavlakis GN; HIV Vaccine Trials Network 119(HVTN 119) Study Team. Focusing HIV-1 Gag T cell responses to highly conserved regions by DNA vaccination in HVTN 119. JCI Insight. 2024 Aug 1;9(18):e180819. doi: 10.1172/jci.insight.180819. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Vaccine | P24CE1/2(CE/CE) + gag vaccines |
| FG001 | Group 2: Vaccine | P55gag (gag/gag) vaccines |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2017 | Jul 9, 2021 |
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| p55^gag pDNA Vaccine | Biological | Administered bilaterally using the TDS-IM EP device |
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| IL-12 pDNA Adjuvant | Biological | Administered bilaterally using the TDS-IM EP device |
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| Placebo | Biological | Administered bilaterally using the TDS-IM EP device |
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| Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device | Device | The TDS-IM EP device will be used to administer study product(s). |
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| Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, Days 14, 42, 98, 182 and 273 |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, Days 14, 42, 98, 175 and 273 |
| Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | Measured during screening, Days 14, 42, 98, 175 and 273 |
| Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time | Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin. |
| Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm | Measured through Month 18 |
| Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end ("no pain" and "worst pain"). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS) | Measured during Day 0, 28, 84 and 168 |
| Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Distribution of responses to questions regarding acceptability of study injection procedures [ Visits 3, 5, 8, 10] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember) | Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175) |
| Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools and the total number of positive responses was defined as the breadth. | M1.5 and M6.5 |
| M0, M1.5 and M6.5 |
| CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Athe Mixture Models for Single-cell Assays (MIMOSA) statistical framework was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. | M0, M1.5 and M6.5 |
| Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Percentage of CD4+ T cells expressing CD40L+ was used as the magnititudes response for ICS assay. | M0, M1.5 and M6.5 |
| CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. | M0, M1.5 and M6.5 |
| Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools. Percentage of CD8+ T cells expressing IFN-gamma was used as the magnitude response. The background-substracted magnitude was summarized by treatment group. The negative reading of magnitude is due to background substracted. | M1.5 and M6.5 |
| Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | The frequency of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA).Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the MFI minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | M6.5 |
| Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | The magnitude of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA). Serum HIV-1-specific IgG antibody responses are measured at the 1:50 dilution against the p24gag antigen on all available samples .The a background-subtracted mean fluorescent intensity (MFI) at the 1:50 dilution were used to summarize the magnitudes at a given time-point. MFI will be used to determine the positivity of samples. Samples from post-enrollment visits are declared to have positive responses if they meet three conditions: (1) the MFI* values are greater than the antigen-specific cutoff (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI), (2) the MFI* values are greater than 3 times the baseline (day 0) MFI* values, and (3) the MFI values are greater than 3 times the baseline MFI values. The values in Groups 1 and 2 are correct as currently reported. | M6.5 |
| Decatur |
| Georgia |
| 30030 |
| United States |
| Case Clinical Research Site | Cleveland | Ohio | 44106 | United States |
| FG002 |
| Group 3: Control 1 |
Placebo: Sodium Chloride, USP 0.9% |
| FG003 | Group 4: Control 2 | Placebo: Sodium Chloride, USP 0.9% |
| Safety Population |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Vaccine | P24CE1/2(CE/CE) + gag vaccines |
| BG001 | Group 2: Vaccine | P55gag (gag/gag) vaccines |
| BG002 | Group 3: Control 1 | Placebo: Sodium Chloride, USP 0.9% |
| BG003 | Group 4: Control 2 | Placebo: Sodium Chloride, USP 0.9% |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Posted | Count of Participants | Participants | Measured through Month 0, 1, 3, 6 |
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| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Posted | Count of Participants | Participants | Measured through Month 0, 1, 3, 6 |
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| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove | Posted | Count of Participants | Participants | Measured through Month 0, 1, 3, 6 |
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| Primary | Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L | For each local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | U/L | Measured during screening, Days 14, 42, 98, 182 and 273 |
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| Primary | Chemistry and Hematology Laboratory Measures - Creatinine in g/dL | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening, Days 14, 42, 98, 182 and 273 |
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| Primary | Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening, Days 14, 42, 98, 182 and 273 |
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| Primary | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | 1000*cells/mm^3 | Measured during screening, Days 14, 42, 98, 175 and 273 |
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| Primary | Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | 1000*cells/mm^3 | Measured during screening, Days 14, 42, 98, 175 and 273 |
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| Primary | Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 | The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. Visit schedule is not the same for each laboratory measures. For visits not on the schedule, number analyzed is 0 or applicable participants number. | Posted | Count of Participants | Participants | Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin. |
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| Primary | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm | Posted | Count of Participants | Participants | Measured through Month 18 |
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| Primary | Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168) | A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end ("no pain" and "worst pain"). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS) | One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment visit. One participant in Group 2 experienced EP device difficulty on enrollment visit. These two participants had no Visual Analog Scale - Pain Assessment Scores. | Posted | Median | Inter-Quartile Range | Score | Measured during Day 0, 28, 84 and 168 |
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| Primary | Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10] | Distribution of responses to questions regarding acceptability of study injection procedures [ Visits 3, 5, 8, 10] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember) | One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment. One participant in Group 2 had an interim visit done as the visit was done prior to the visit 3.0 window opening. Data Manager instructed site to complete the interim visit and then following w/ a missed visit. These two cases were missed in the enrollment visit. | Posted | Count of Participants | Participants | Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175) |
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| Primary | Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5] | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools and the total number of positive responses was defined as the breadth. | Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan. | Posted | Mean | 95% Confidence Interval | Number of targeted CEs | M1.5 and M6.5 |
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| Secondary | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. | Immunogenicity Population | Posted | Count of Participants | Participants | M0, M1.5 and M6.5 |
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| Secondary | CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Athe Mixture Models for Single-cell Assays (MIMOSA) statistical framework was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. | Immunogenicity Population | Posted | Count of Participants | Participants | M0, M1.5 and M6.5 |
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| Secondary | Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Percentage of CD4+ T cells expressing CD40L+ was used as the magnititudes response for ICS assay. | Immunogenicity Population | Posted | Median | Inter-Quartile Range | percentage | M0, M1.5 and M6.5 |
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| Secondary | CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5] | Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive. | Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan. | Posted | Count of Participants | Participants | M0, M1.5 and M6.5 |
|
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| Secondary | Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5] | For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools. Percentage of CD8+ T cells expressing IFN-gamma was used as the magnitude response. The background-substracted magnitude was summarized by treatment group. The negative reading of magnitude is due to background substracted. | Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan. | Posted | Median | Inter-Quartile Range | percentage | M1.5 and M6.5 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | The frequency of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA).Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the MFI minus blank (MFI*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values. | Immunogenicity Population | Posted | Count of Participants | Participants | M6.5 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5] | The magnitude of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA). Serum HIV-1-specific IgG antibody responses are measured at the 1:50 dilution against the p24gag antigen on all available samples .The a background-subtracted mean fluorescent intensity (MFI) at the 1:50 dilution were used to summarize the magnitudes at a given time-point. MFI will be used to determine the positivity of samples. Samples from post-enrollment visits are declared to have positive responses if they meet three conditions: (1) the MFI* values are greater than the antigen-specific cutoff (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI), (2) the MFI* values are greater than 3 times the baseline (day 0) MFI* values, and (3) the MFI values are greater than 3 times the baseline MFI values. The values in Groups 1 and 2 are correct as currently reported. | Immunogenicity Population | Posted | Median | Inter-Quartile Range | adjusted Mean fluorescent intensity (MFI | M6.5 |
|
Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Vaccine | P24CE1/2(CE/CE) + gag vaccines | 0 | 25 | 0 | 25 | 16 | 25 |
| EG001 | Group 2: Vaccine | P55gag (gag/gag) vaccines | 0 | 25 | 0 | 25 | 17 | 25 |
| EG002 | Group 3: Control 1 | Placebo: Sodium Chloride, USP 0.9% | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Group 4: Control 2 | Placebo: Sodium Chloride, USP 0.9% | 0 | 3 | 0 | 3 | 2 | 3 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Blood and lymphatic system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Gastrointestinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | General disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Complication of device removal | General disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA 22.0 | Non-systematic Assessment |
| |
| Oral papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Psychiatric disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Reproductive system and breast disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Premenstrual dysphoric disorder | Reproductive system and breast disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Respiratory, thoracic and mediastinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Any Event in SOC | Skin and subcutaneous tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDRA 22.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations | Fred Hutchinson Cancer Research Center | 206-667-5812 | jandries@fredhutch.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2020 | Jul 9, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018274 | Electroporation |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
Not provided
Not provided
| 18 - 20 |
|
| 21 - 30 |
|
| 31 - 40 |
|
| 41 - 50 |
|
| Over 50 |
|
| Unknown or Not Reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Tenderness |
|
| Pain and/or Tenderness |
|
|
|
|
|
| Group 4: Control 2 |
Placebo: Sodium Chloride, USP 0.9% |
|
|
|
|
|
|
|
|
|
|
| OG002 |
| Group 3: Control 1 |
Placebo: Sodium Chloride, USP 0.9% |
| OG003 | Group 4: Control 2 | Placebo: Sodium Chloride, USP 0.9% |
|
|
|
| Group 4: Control 2 |
Placebo: Sodium Chloride, USP 0.9% |
|
|
Placebo: Sodium Chloride, USP 0.9% |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo: Sodium Chloride, USP 0.9% |
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
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