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This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP) in healthy adults.
This is a Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine regimen (Day 0 and 28) with Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP, VRC-CHKVLP059-00-VP) in healthy adults ages 18-60 years old that reside in CHIKV endemic regions.
The hypothesis is that the vaccine regimen is safe and induces a neutralizing antibody response to CHIKV. The primary objectives are to evaluate safety and tolerability of a 2-injection investigational vaccine regimen of VRC-CHKVLP059-00-VP at 20 mcg compared to placebo (PBS) in healthy adults in CHIKV endemic areas. The secondary objective is to evaluate neutralizing antibody response in vaccine recipients. The exploratory objectives relate to assessing incidence of CHIKV infection in vaccine and placebo recipients, as well as antigen-specific humoral and cellular immune responses during the study.
The expected study duration per subject is approximately 72 weeks with intramuscular (IM) injections scheduled at Day 0 and Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Experimental | Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). |
|
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Placebo Comparator | Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-CHKVLP059-00-VP | Biological | VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | 7 days after any injection |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | 7 days after any injection |
| Number of Subjects With an Abnormal Laboratory Result | Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56. | 4 weeks after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. | Week 8 |
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population |
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Inclusion Criteria:
A subject must meet all of the following criteria:
Laboratory Criteria within 56 days prior to enrollment:
Criteria applicable to women of childbearing potential:
Exclusion Criteria:
A subject will be excluded if one or more of the following conditions apply:
Women Specific:
-Planning to become pregnant during the 16 weeks after enrollment in the study
Subject has received any of the following substances:
Subject has a history of any of the following clinically significant conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Rosario, MD | San Juan Hospital | Principal Investigator |
| Clemente Diaz, MD | Puerto Rico Clinical and Translational Research Consortium | Principal Investigator |
| Bruno Hoen, MD | University Hospital Pointe-a-Pitre, Guadeloupe | Principal Investigator |
| Yeycy Donastorg, MD | Instituto Dermatológico y CirugÃa de Piel | Principal Investigator |
| Jean W Pape, MD | Centres GHESKIO, Haiti | Principal Investigator |
| Andre Cabie, MD | Centre Hospitalier Universitaire (CHU), Martinique | Principal Investigator |
| Julie Ledgerwood, DO | VRC, NIAID, NIH | Study Chair |
| Grace Chen, MD | VRC, NIAID, NIH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dermatológico y CirugÃa de Piel | Santo Domingo | Dominican Republic | ||||
| University Hospital of Pointe-Ã -Pitre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25132507 | Background | Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52. doi: 10.1016/S0140-6736(14)61185-5. Epub 2014 Aug 14. | |
| 26132956 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997). |
| 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 11, 2018 |
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| VRC-PBSPLA043-00-VP | Other | VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for "Any AE" is the number of subjects reporting at least one or more AEs. | Through study completion, an average of 72 weeks after first injection |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs were reported from receipt of first study injection through the last expected study visit at 72 weeks. Grading (Mild, Moderate, Severe, Life-threatening, and Death) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple SAEs is counted only once. | Through study completion, an average of 72 weeks after first injection |
| Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks. | Through study completion, an average of 72 weeks after first injection |
Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. |
| Week 8 |
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. | 4 weeks after last study injection |
| Pointe-Ã -Pitre |
| Guadeloupe |
| Centres GHESKIO | Port-au-Prince | Haiti |
| Centre Hospitalier Universitaire (CHU), Martinique | Fort-de-France | 0596 55 20 00 | Martinique |
| San Juan Hospital, Research Unit | Rio Piedras | 00935 | Puerto Rico |
| Puerto Rico Clinical and Translational Research Consortium | San Juan | 00936-5067 | Puerto Rico |
| Background |
| Weaver SC, Lecuit M. Chikungunya Virus Infections. N Engl J Med. 2015 Jul 2;373(1):94-5. doi: 10.1056/NEJMc1505501. No abstract available. |
| 17698645 | Background | Powers AM, Logue CH. Changing patterns of chikungunya virus: re-emergence of a zoonotic arbovirus. J Gen Virol. 2007 Sep;88(Pt 9):2363-2377. doi: 10.1099/vir.0.82858-0. No abstract available. |
| 32286643 | Result | Chen GL, Coates EE, Plummer SH, Carter CA, Berkowitz N, Conan-Cibotti M, Cox JH, Beck A, O'Callahan M, Andrews C, Gordon IJ, Larkin B, Lampley R, Kaltovich F, Gall J, Carlton K, Mendy J, Haney D, May J, Bray A, Bailer RT, Dowd KA, Brockett B, Gordon D, Koup RA, Schwartz R, Mascola JR, Graham BS, Pierson TC, Donastorg Y, Rosario N, Pape JW, Hoen B, Cabie A, Diaz C, Ledgerwood JE; VRC 704 Study Team. Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial. JAMA. 2020 Apr 14;323(14):1369-1377. doi: 10.1001/jama.2020.2477. |
| 37690874 | Derived | McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9. |
| FG001 | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
| Received 1st Injection |
|
| Received 2nd Injection |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Population includes all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997). |
| BG001 | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||
| Body Mass Index (BMI) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis. | Posted | Count of Participants | Participants | 7 days after any injection |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis. | Posted | Count of Participants | Participants | 7 days after any injection |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With an Abnormal Laboratory Result | Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56. | Population included all enrolled subjects who had laboratory results available at any study visit post baseline. | Posted | Count of Participants | Participants | 4 weeks after last injection |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for "Any AE" is the number of subjects reporting at least one or more AEs. | Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis. | Posted | Count of Participants | Participants | Through study completion, an average of 72 weeks after first injection |
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| Primary | Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs were reported from receipt of first study injection through the last expected study visit at 72 weeks. Grading (Mild, Moderate, Severe, Life-threatening, and Death) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple SAEs is counted only once. | Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis. | Posted | Count of Participants | Participants | Through study completion, an average of 72 weeks after first injection |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks. | Population included all enrolled subjects who received at least one injection. Four subjects in Group 1 did not receive product. | Posted | Count of Participants | Participants | Through study completion, an average of 72 weeks after first injection |
| |||||||||||||||||||||||||||||||||
| Secondary | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. | Subjects who received 2 injections within window as assigned by the randomization schedule and didn't experience any other major protocol deviations prior to Week 8 visit, including those that were CHIKV-infected prior to receipt of 2nd injection who didn't experience deviations prior to infection. None were CHIKV-infected prior to 2nd injection. | Posted | Geometric Mean | 95% Confidence Interval | titer | Week 8 |
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| Secondary | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. | Intent-to-Treat (ITT) population included all enrolled subjects, analyzed according to the randomized vaccine, with immunogenicity data. | Posted | Geometric Mean | 95% Confidence Interval | titer | Week 8 |
|
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| Secondary | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. | Modified Intent-to-Treat (mITT) population included all enrolled subjects who received at least one injection with non-missing immunogenicity data at their Week 8 visit, without exclusions for protocol deviations or censoring for CHIKV infection | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks after last study injection |
|
Solicited adverse events (AEs) were reported for 7 days after any injection. Unsolicited AEs were reported from receipt of the first injection through 4 weeks after the last study injection administered. Following the time period defined for AEs through the last expected study visit at 72 weeks, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first injection through the last expected study visit at 72 weeks.
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported by subjects who received at least one injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity. A subject with multiple SAEs is counted only once.
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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: VRC-CHKVLP059-00-VP 20 mcg | Group 1 subjects were randomized to receive two intramuscular (IM) injections of CHIKV VLP vaccine (VRC-CHKVLP059-00-VP) at Day 0 and Day 28 (+14 days) at a dose of 20 micrograms (mcg). VRC-CHKVLP059-00-VP: VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997). | 0 | 197 | 4 | 197 | 123 | 197 |
| EG001 | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. | 0 | 198 | 11 | 198 | 128 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (21.1) | Non-systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Polycystic ovaries | Reproductive system and breast disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
| |
| Administration Site Pain/Tenderness | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Joint Pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
|
Exploratory immunogenicity analyses (to evaluate humoral and cellular responses to VRC-CHKVLP059-00-VP at additional time points by antibody assays that include antigen-specific ELISA and neutralization assay) were not completed and are not reported.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Chen, Deputy Chief, Clinical Trials Program, Vaccine Research Center | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 240-669-2809 | grace.chen@nih.gov |
| Feb 4, 2020 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 31-40 years |
|
| 41-50 years |
|
| 51-60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Puerto Rico |
|
| Guadeloupe |
|
| Dominican Republic |
|
| Martinique |
|
| 18.5-24.9 kg/m^2 |
|
| 25.0-29.9 kg/m^2 |
|
| 30.0 kg/m^2 or over |
|
| Missing |
|
| Moderate |
|
| Severe |
|
| Swelling |
|
| Redness |
|
| Any Local Symptom |
|
| OG001 | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
|
|
|
|
Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
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|
Group 2 subjects were randomized to receive two intramuscular (IM) injections of Phosphate Buffered Saline (VRC-PBSPLA043-00-VP) placebo at Day 0 and Day 28 (+14 days). VRC-PBSPLA043-00-VP: VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine. |
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| Units | Counts |
|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|
| Moderate |
|
| Severe |
|