Chikungunya Virus Infection
Conditions
Keywords
Antibody Response, Immune Response, Healthy Volunteer, Vaccine-Mediated Protection, Chikungunya Virus, Vaccines, Virus-like Particles
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALVRC-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).
OTHERVRC-PBSPLA043-00-VP
VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
A subject must meet all of the following criteria: * 18 to 60 years old * Available for clinical follow-up through Study Week 72 * Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process * Able and willing to complete the informed consent process * Willing to donate blood for sample storage to be used for future research * In good general health, with a body mass index (BMI)≤40, without clinically significant medical history, and has satisfactorily completed screening * Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment Laboratory Criteria within 56 days prior to enrollment: * Hemoglobin either within institutional normal limits or accompanied by site physician approval as consistent with healthy adult status * White blood cells either within institutional normal range or accompanied by site physician approval as consistent with healthy adult status * Platelets = 125,000 - 500,000/mm3 * Alanine aminotransferase (ALT) ≤ 1.25 x upper limit of normal (ULN) * Serum creatinine ≤ 1.1 x ULN based on site institutional normal range * Negative result on a human immunodeficiency virus (HIV) test that meets local standards for identification of HIV infection * Negative result on the Chikungunya virus (CHIKV) screening antibody assay. Criteria applicable to women of childbearing potential: * Negative human chorionic gonadotropin pregnancy test (urine or serum) on day of enrollment * Agree to use an effective means of birth control from 21 days prior to enrollment through 12 weeks after the last study injection
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: * Systemic immunosuppressive medications within 2 weeks prior to enrollment * Blood products within 16 weeks prior to enrollment * Immunoglobulin within 8 weeks prior to enrollment * Prior vaccinations with an investigational CHIKV vaccine * Investigational research agents within 4 weeks prior to enrollment * Any vaccination within 2 weeks prior to enrollment * Current anti-tuberculosis (TB) prophylaxis or therapy Subject has a history of any of the following clinically significant conditions: * A history of immune-mediated or clinically significant arthritis * Serious reactions to vaccines that preclude receipt of study injections as determined by the investigator * Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema * Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids * Diabetes mellitus (type I or II), with the exception of gestational diabetes * Idiopathic urticaria within the past year * Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws * Malignancy that is active or history of a malignancy that is likely to recur during the period of the study * Seizure in the past 3 years or treatment for a seizure disorder within the last 3 years * Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen * Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; or a history of suicide plan or attempt within the five years prior to enrollment * Any medical or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | Through study completion, an average of 72 weeks after first injection | 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. |
| Number of Subjects With an Abnormal Laboratory Result | 4 weeks after last injection | 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. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Through study completion, an average of 72 weeks after first injection | 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. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Through study completion, an average of 72 weeks after first injection | 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. |
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | 7 days after 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). |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | 7 days after 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population | Week 8 | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. |
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | 4 weeks after last study injection | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. |
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | Week 8 | Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection. |
Countries
Dominican Republic, Guadeloupe, Haiti, Martinique, Puerto Rico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 201 |
| 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. | 199 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled, but did not receive product | 4 | 0 |
| Overall Study | Illness/Injury unrelated to product | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Moved from area | 2 | 3 |
| Overall Study | Physician Decision | 1 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Total |
|---|---|---|---|
| Age, Customized 18-20 years | 9 Participants | 16 Participants | 25 Participants |
| Age, Customized 21-30 years | 75 Participants | 66 Participants | 141 Participants |
| Age, Customized 31-40 years | 51 Participants | 53 Participants | 104 Participants |
| Age, Customized 41-50 years | 34 Participants | 40 Participants | 74 Participants |
| Age, Customized 51-60 years | 30 Participants | 26 Participants | 56 Participants |
| Body Mass Index (BMI) 18.5-24.9 kg/m^2 | 93 Participants | 94 Participants | 187 Participants |
| Body Mass Index (BMI) 25.0-29.9 kg/m^2 | 57 Participants | 56 Participants | 113 Participants |
| Body Mass Index (BMI) 30.0 kg/m^2 or over | 44 Participants | 45 Participants | 89 Participants |
| Body Mass Index (BMI) Missing | 0 Participants | 1 Participants | 1 Participants |
| Body Mass Index (BMI) under 18.5 kg/m^2 | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 138 Participants | 137 Participants | 275 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 64 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized More than one race | 20 Participants | 21 Participants | 41 Participants |
| Race/Ethnicity, Customized North, South or Central American Native | 143 Participants | 144 Participants | 287 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 15 Participants | 13 Participants | 28 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 20 Participants | 34 Participants |
| Region of Enrollment Dominican Republic | 53 Participants | 53 Participants | 106 Participants |
| Region of Enrollment Guadeloupe | 14 Participants | 16 Participants | 30 Participants |
| Region of Enrollment Haiti | 30 Participants | 32 Participants | 62 Participants |
| Region of Enrollment Martinique | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment Puerto Rico | 87 Participants | 85 Participants | 172 Participants |
| Sex: Female, Male Female | 103 Participants | 96 Participants | 199 Participants |
| Sex: Female, Male Male | 96 Participants | 105 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 197 | 0 / 198 |
| other Total, other adverse events | 123 / 197 | 128 / 198 |
| serious Total, serious adverse events | 4 / 197 | 11 / 198 |
Outcome results
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).
Time frame: 7 days after any injection
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | None | 136 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Mild | 58 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Moderate | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | None | 192 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Mild | 2 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Moderate | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | None | 196 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Mild | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Moderate | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | None | 133 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Mild | 58 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Moderate | 6 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | None | 161 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | None | 198 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Mild | 37 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | None | 161 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Moderate | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Mild | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Pain/Tenderness | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Moderate | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | None | 197 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Moderate | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Mild | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Local Symptom | Mild | 36 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Moderate | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Redness | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Swelling | Severe | 0 Participants |
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.
Time frame: Through study completion, an average of 72 weeks after first injection
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related to study product | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Serious Adverse Events (SAEs) | Unrelated to study product | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Serious Adverse Events (SAEs) | Related to study product | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Serious Adverse Events (SAEs) | Unrelated to study product | 11 Participants |
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).
Time frame: 7 days after any injection
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Mild | 42 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Mild | 7 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Mild | 8 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Moderate | 2 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Mild | 13 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Moderate | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | None | 110 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Severe | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Mild | 65 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Moderate | 21 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Moderate | 4 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Severe | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | None | 173 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | None | 144 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Moderate | 11 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Mild | 46 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Mild | 20 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Moderate | 7 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Moderate | 4 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | None | 151 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | None | 180 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Mild | 41 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Moderate | 5 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | None | 186 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Severe | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | None | 188 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | None | 143 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | None | 113 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Mild | 47 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Moderate | 11 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | None | 186 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Mild | 10 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Moderate | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Chills | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | None | 182 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Mild | 12 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Moderate | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Nausea | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | None | 184 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Mild | 12 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Moderate | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Joint Pain | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | None | 193 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Mild | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Moderate | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Temperature | Severe | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Headache | None | 140 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Mild | 68 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Moderate | 16 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Any Systemic Symptom | Severe | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | None | 150 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Mild | 41 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Moderate | 7 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Malaise | Severe | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | None | 162 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Mild | 34 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Moderate | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection | Myalgia | Severe | 0 Participants |
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.
Time frame: Through study completion, an average of 72 weeks after first injection
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Musculoskeletal and connective tissue disorders | 5 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | General disorders & administration site conditions | 2 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Neoplasms benign, malignant and unspecified | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Cardiac disorders | 7 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Nervous system disorders | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Infections and infestations | 33 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Pregnancy, puerperium & perinatal conditions | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Eye disorders | 2 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Injury, poisoning & procedural complications | 6 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Psychiatric disorders | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Renal and urinary disorders | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Blood and lymphatic system disorders | 45 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Reproductive system and breast disorders | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Investigations | 5 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Respiratory, thoracic and mediastinal disorders | 9 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Gastrointestinal disorders | 11 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Skin and subcutaneous tissue disorders | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Metabolism and nutrition disorders | 0 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Surgical and medical procedures | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Endocrine disorders | 1 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Vascular disorders | 15 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE | 104 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Vascular disorders | 13 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE | 111 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Blood and lymphatic system disorders | 46 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Cardiac disorders | 14 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Endocrine disorders | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Eye disorders | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Gastrointestinal disorders | 11 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | General disorders & administration site conditions | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Infections and infestations | 39 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Injury, poisoning & procedural complications | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Investigations | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Metabolism and nutrition disorders | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Musculoskeletal and connective tissue disorders | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Neoplasms benign, malignant and unspecified | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Nervous system disorders | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Pregnancy, puerperium & perinatal conditions | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Psychiatric disorders | 0 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Renal and urinary disorders | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Reproductive system and breast disorders | 2 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Respiratory, thoracic and mediastinal disorders | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Skin and subcutaneous tissue disorders | 9 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Surgical and medical procedures | 1 Participants |
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.
Time frame: 4 weeks after last injection
Population: Population included all enrolled subjects who had laboratory results available at any study visit post baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Eosinophils | 10 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Platelets | 6 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | RBC | 28 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | WBC | 21 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Hematocrit | 39 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Neutrophils | 32 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | MCV | 28 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | ALT | 7 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Monocytes | 5 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Lymphocytes | 7 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Basophils | 3 Participants |
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With an Abnormal Laboratory Result | Hemoglobin | 50 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Basophils | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | ALT | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | WBC | 18 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Platelets | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Neutrophils | 30 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Lymphocytes | 4 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Eosinophils | 5 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | RBC | 21 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Hematocrit | 45 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | MCV | 23 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Monocytes | 6 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With an Abnormal Laboratory Result | Hemoglobin | 70 Participants |
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.
Time frame: Through study completion, an average of 72 weeks after first injection
Population: Population included all enrolled subjects who received at least one injection. Four subjects in Group 1 did not receive product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | 1 Participants |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | 0 Participants |
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.
Time frame: Week 8
Population: Intent-to-Treat (ITT) population included all enrolled subjects, analyzed according to the randomized vaccine, with immunogenicity data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population | 1995.7 titer |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population | 42.6 titer |
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.
Time frame: 4 weeks after last study injection
Population: 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
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | 2004.5 titer |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | 42.8 titer |
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.
Time frame: Week 8
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | 2088.2 titer |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | 41.1 titer |