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| ID | Type | Description | Link |
|---|---|---|---|
| 20-I-0096 |
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Background:
HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a way to prevent HIV infection. Antibodies are made by the human body to fight germs. Researchers want to test an antibody, CAP256V2LS.
Objective:
To test CAP256V2LS to see if it is safe and how the body responds to it.
Eligibility:
Healthy people, ages 18-60
Design:
Participants were screened with a medical history, physical exam, and blood tests. Some females had a pregnancy test.
Participants were assigned to one of two groups. Based on their group, they got 1 dose of CAP256V2LS in 1 of 2 ways:
On the day they got CAP256V2LS, participants gave blood samples at different time points.
Participants were asked to check their temperature every day for 7 days after receiving CAP256V2LS. They used a tool to measure any redness, swelling, or bruising they may have at the site where they received the study drug.
Participants had visits at least 2-3 times during the first week after they got CAP256V2LS. Then they had about 9 more visits over the next 6 months. Visits included blood tests.
Design:
This open-label study evaluated CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis was that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis was that CAP256V2LS will be detectable in human sera with a definable half-life.
Study Product:
The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS Programme of Research in South Africa (CAPRISA) and is manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use 10 mL glass vials. R-Gene10 was added as a stabilizing agent to IV doses of CAP256V2LS. R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine Hydrochloride, USP in Water for Injection (equivalent to a 10% solution).
Participants:
Healthy participants, 18-60 years of age
Study Plan:
This open-label study included 2 dosing regimens with CAP256V2LS administered at 5 mg/kg IV and 5 mg/kg SC. A single dose of the study product was administered on Day 0 as shown below.
VRC 611 Study Design
Group 1
Group 2
Total Participants: 10
Duration:
Study participation was approximately 24 weeks from the Day 0 product administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: CAP256V2LS (5 mg/kg IV) | Experimental | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) |
|
| Group 2: CAP256V2LS (5 mg/kg SC) | Experimental | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-HIVMAB0102-00-AB | Biological | The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | 7 days after CAP256V2LS product administration, at approximately Week 1 |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | 7 days after CAP256V2LS product administration, at approximately Week 1 |
| Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CAP256V2LS Product Administration | Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax) | Cmax is the peak serum concentration that CAP256V2LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. | Baseline through 24 weeks after CAP256V2LS product administration |
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A volunteer must have met all of the following criteria to be included:
Able and willing to complete the informed consent process
Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
Available for clinical follow-up through the last study visit
18 to 60 years of age
Based on medical history and physical examination, in good health and without clinically significant findings within 84 days prior to enrollment.
Weight less than or equal to 115 kg
Willing to have blood samples collected, stored indefinitely, and used for research purposes
Laboratory Criteria within 84 days prior to enrollment:
White Blood Cell (WBC) 2,500-12,000/mm^3
WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
Platelets = 125,000-500,000/mm^3
Hemoglobin within institutional normal range or accompanied by the PI or designee approval
Creatinine less than or equal to 1.1 x upper limit of normal (ULN) based on the institutional normal range
Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN based on the institutional normal range
Negative for HIV infection by an FDA approved method of detection
Criteria Specific to Women of Childbearing Potential:
Negative beta-human chorionic gonadotropin (HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration
Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the duration of study participation
EXCLUSION CRITERIA:
A volunteer was excluded if one or more of the following conditions applied:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Wu, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25119033 | Background | Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13. | |
| 24590074 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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Healthy adults were recruited for the study at the NIH Clinical Center in Bethesda, Maryland, USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: CAP256V2LS (5 mg/kg IV) | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| FG001 | Group 2: CAP256V2LS (5 mg/kg SC) | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Population included all enrolled participants. Weight represents weight at time of enrollment. Age represents age at enrollment day.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: CAP256V2LS (5 mg/kg IV) | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age represents age at enrollment day. |
| 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 Within 7 Days of CAP256V2LS Product Administration | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | Population included all enrolled participants who received CAP256V2LS and provided safety data (via diary card). | Posted | Count of Participants | Participants | 7 days after CAP256V2LS product administration, at approximately Week 1 |
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit up to Week 24.
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
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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 | Group 1: CAP256V2LS (5 mg/kg IV) | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VRC Clinical Trials Program Leadership | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-451-8715 | ctpleadership@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 7, 2022 | Nov 2, 2023 | Prot_SAP_ICF_001.pdf |
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|
|
| Day 0 through 4 weeks after CAP256V2LS Product Administration |
| Number of Participants With Serious Adverse Events (SAEs) Following CAP256V2LS Product Administration | SAEs were recorded from receipt of study product administration through the last expected study visit at Week 24. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 after CAP256V2LS product administration through the study participation, up to Week 24 |
| Number of Participants With New Chronic Medical Conditions Following CAP256V2LS Product Administration | New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 after CAP256V2LS product administration through the study participation, up to Week 24 |
| Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration | Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential and Chemistry (ALT and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Comprehensive metabolic panel (CMP) was collected at baseline, and 2 weeks after product administration and as needed at additional timepoints. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used. | Day 0 through 4 weeks after CAP256V2LS Product Administration |
| Pharmacokinetic (PK) Parameters of CAP256V2LS: Time to Reach Maximum Observed Serum Concentration (Tmax) | Tmax is the time it takes to reach Cmax of CAP256V2LS after it has been administered; it is determined based on the summary PK curve for each dose group. | Baseline through 24 weeks after CAP256V2LS product administration |
| Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b) | Beta half-life (T1/2b) is the time required for half of the CAP256V2LS product to be eliminated from the serum. | Baseline through 24 weeks after CAP256V2LS product administration |
| Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate | Clearance is the rate of CAP256V2LS elimination divided by the plasma CAP256V2LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F). | Baseline through 24 weeks after CAP256V2LS product administration |
| Pharmacokinetic (PK) Parameters of CAP256V2LS: Volume of Distribution | Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F). | Baseline through 24 weeks after CAP256V2LS product administration |
| Background |
| Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program; Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2. |
| 26468542 | Background | Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. Print 2016 Jan 1. |
| BG001 | Group 2: CAP256V2LS (5 mg/kg SC) | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Age represents age at enrollment day. | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight (kg) | Weight represents weight at time of enrollment. | Mean | Standard Deviation | kg |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Group 1: CAP256V2LS (5 mg/kg IV) | CAP256V2LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
| OG001 | Group 2: CAP256V2LS (5 mg/kg SC) | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. |
|
|
| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CAP256V2LS Product Administration | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | Population included all enrolled participants who received CAP256V2LS and provided safety data (via diary card). | Posted | Count of Participants | Participants | 7 days after CAP256V2LS product administration, at approximately Week 1 |
|
|
|
| Primary | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CAP256V2LS Product Administration | Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received CAP256V2LS and had safety data collected (via clinical assessment and/or lab results). | Posted | Count of Participants | Participants | Day 0 through 4 weeks after CAP256V2LS Product Administration |
|
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) Following CAP256V2LS Product Administration | SAEs were recorded from receipt of study product administration through the last expected study visit at Week 24. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received CAP256V2LS and had safety data collected (via clinical assessment and/or lab results). | Posted | Count of Participants | Participants | Day 0 after CAP256V2LS product administration through the study participation, up to Week 24 |
|
|
|
| Primary | Number of Participants With New Chronic Medical Conditions Following CAP256V2LS Product Administration | New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled participants who received CAP256V2LS and had safety data collected (via clinical assessment and/or lab results). | Posted | Count of Participants | Participants | Day 0 after CAP256V2LS product administration through the study participation, up to Week 24 |
|
|
|
| Primary | Number of Participants With Abnormal Laboratory Measures of Safety Following CAP256V2LS Product Administration | Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential and Chemistry (ALT and creatinine) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Comprehensive metabolic panel (CMP) was collected at baseline, and 2 weeks after product administration and as needed at additional timepoints. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used. | Population includes all enrolled participants who received CAP256V2LS and had safety data collected via lab results. | Posted | Count of Participants | Participants | Day 0 through 4 weeks after CAP256V2LS Product Administration |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameters of CAP256V2LS: Maximum Observed Serum Concentration (Cmax) | Cmax is the peak serum concentration that CAP256V2LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. | Population included participants who received CAP256V2LS (N=10). | Posted | Mean | Standard Deviation | μg/ml | Baseline through 24 weeks after CAP256V2LS product administration |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameters of CAP256V2LS: Time to Reach Maximum Observed Serum Concentration (Tmax) | Tmax is the time it takes to reach Cmax of CAP256V2LS after it has been administered; it is determined based on the summary PK curve for each dose group. | Population included participants who received CAP256V2LS (N=10). | Posted | Mean | Standard Deviation | days | Baseline through 24 weeks after CAP256V2LS product administration |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameters of CAP256V2LS: Beta Half-life (T1/2b) | Beta half-life (T1/2b) is the time required for half of the CAP256V2LS product to be eliminated from the serum. | Population included participants who received CAP256V2LS (N=10). | Posted | Mean | Standard Deviation | days | Baseline through 24 weeks after CAP256V2LS product administration |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameters of CAP256V2LS: Clearance Rate | Clearance is the rate of CAP256V2LS elimination divided by the plasma CAP256V2LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F). | Population included participants who received CAP256V2LS (N=10). | Posted | Mean | Standard Deviation | ml/day | Baseline through 24 weeks after CAP256V2LS product administration |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameters of CAP256V2LS: Volume of Distribution | Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F). | Population included participants who received CAP256V2LS (N=10). | Posted | Mean | Standard Deviation | Liter | Baseline through 24 weeks after CAP256V2LS product administration |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Group 2: CAP256V2LS (5 mg/kg SC) | CAP256V2LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-HIVMAB0102-00-AB: The VRC-HIVMAB0102-00-AB (CAP256V2LS) broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo. | 0 | 5 | 0 | 5 | 5 | 5 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Administration site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Administration site pruritus | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Administration site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Administration site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Muscle Aches |
|
| Headache |
|
| Chills |
|
| Nausea |
|
| Joint Pain |
|
| Temperature (Fever) |
|
| Any Systemic Symptom |
|
| Total Number of Participants who had One or More Non-Serious Unsolicited AE |
|
| Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product |
|
| Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product |
|
| Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs |
|