A Phase 2 interventional study of VRC-CHKVLP059-00-VP and VRC-PBSPLA043-00-VP in Chikungunya Virus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in 5 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Prevention
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.
88 studies on the registry are indexed under Chikungunya Fever; 21 are open to participants now.
This study's enrollment of 400 is above the median of 263 across 57 interventional studies indexed under Chikungunya Fever.
Browse Chikungunya Fever studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A subject must meet all of the following criteria:
Laboratory Criteria within 56 days prior to enrollment:
Criteria applicable to women of :
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 conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Biological: VRC-CHKVLP059-00-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).
Other: VRC-PBSPLA043-00-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).
VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
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
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
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
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
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
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
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
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
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
| Milestone | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Started | 201 | 199 |
| Received 1st injection | 197 | 199 |
| Received 2nd injection | 192 | 192 |
| Completed | 180 | 183 |
| Not completed | 21 | 16 |
| Withdrew: Enrolled, but did not receive product | 4 | 0 |
| Withdrew: Lost to follow-up | 9 | 6 |
| Withdrew: Moved from area | 2 | 3 |
| Withdrew: Withdrawal by subject | 5 | 3 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Illness/injury unrelated to product | 0 | 1 |
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).
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Pain/Tenderness — None | 136 | 161 |
| Pain/Tenderness — Mild | 58 | 37 |
| Pain/Tenderness — Moderate | 3 | 0 |
| Pain/Tenderness — Severe | 0 | 0 |
| Swelling — None | 192 | 197 |
| Swelling — Mild | 2 | 0 |
| Swelling — Moderate | 3 | 1 |
| Swelling — Severe | 0 | 0 |
| Redness — None | 196 | 198 |
| Redness — Mild | 1 | 0 |
| Redness — Moderate | 0 | 0 |
| Redness — Severe | 0 | 0 |
| Any Local Symptom — None | 133 | 161 |
| Any Local Symptom — Mild | 58 | 36 |
| Any Local Symptom — Moderate | 6 | 1 |
| Any Local Symptom — Severe | 0 | 0 |
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).
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Malaise — None | 144 | 150 |
| Malaise — Mild | 46 | 41 |
| Malaise — Moderate | 7 | 7 |
| Malaise — Severe | 0 | 0 |
| Myalgia — None | 151 | 162 |
| Myalgia — Mild | 41 | 34 |
| Myalgia — Moderate | 5 | 2 |
| Myalgia — Severe | 0 | 0 |
| Headache — None | 143 | 140 |
| Headache — Mild | 42 | 47 |
| Headache — Moderate | 11 | 11 |
| Headache — Severe | 1 | 0 |
| Chills — None | 180 | 186 |
| Chills — Mild | 13 | 10 |
| Chills — Moderate | 4 | 2 |
| Chills — Severe | 0 | 0 |
| Nausea — None | 186 | 182 |
| Nausea — Mild | 8 | 12 |
| Nausea — Moderate | 3 | 4 |
| Nausea — Severe | 0 | 0 |
| Joint Pain — None | 173 | 184 |
| Joint Pain — Mild | 20 | 12 |
| Joint Pain — Moderate | 4 | 2 |
| Joint Pain — Severe | 0 | 0 |
| Temperature — None | 188 | 193 |
| Temperature — Mild | 7 | 2 |
| Temperature — Moderate | 2 | 2 |
| Temperature — Severe | 0 | 1 |
| Any Systemic Symptom — None | 110 | 113 |
| Any Systemic Symptom — Mild | 65 | 68 |
| Any Systemic Symptom — Moderate | 21 | 16 |
| Any Systemic Symptom — Severe | 1 | 1 |
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.
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| ALT | 7 | 4 |
| WBC | 21 | 18 |
| Hemoglobin | 50 | 70 |
| Platelets | 6 | 4 |
| Neutrophils | 32 | 30 |
| Lymphocytes | 7 | 4 |
| Eosinophils | 10 | 5 |
| RBC | 28 | 21 |
| Hematocrit | 39 | 45 |
| MCV | 28 | 23 |
| Monocytes | 5 | 6 |
| Basophils | 3 | 1 |
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.
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Any AE | 104 | 111 |
| Blood and lymphatic system disorders | 45 | 46 |
| Cardiac disorders | 7 | 14 |
| Endocrine disorders | 1 | 0 |
| Eye disorders | 2 | 0 |
| Gastrointestinal disorders | 11 | 11 |
| General disorders & administration site conditions | 2 | 4 |
| Infections and infestations | 33 | 39 |
| Injury, poisoning & procedural complications | 6 | 4 |
| Investigations | 5 | 2 |
| Metabolism and nutrition disorders | 0 | 1 |
| Musculoskeletal and connective tissue disorders | 5 | 4 |
| Neoplasms benign, malignant and unspecified | 0 | 1 |
| Nervous system disorders | 3 | 4 |
| Pregnancy, puerperium & perinatal conditions | 1 | 0 |
| Psychiatric disorders | 1 | 0 |
| Renal and urinary disorders | 0 | 2 |
| Reproductive system and breast disorders | 0 | 2 |
| Respiratory, thoracic and mediastinal disorders | 9 | 4 |
| Skin and subcutaneous tissue disorders | 3 | 9 |
| Surgical and medical procedures | 1 | 1 |
| Vascular disorders | 15 | 13 |
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.
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Related to study product | 0 | 0 |
| Unrelated to study product | 4 | 11 |
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.
| Participants | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events | 1 | 0 |
Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
| titer | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population | 2088.2 (1765.2 to 2474.1) | 41.1 (30.3 to 55.8) |
Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
| titer | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population | 1995.7 (1673.9 to 2379.3) | 42.6 (31.6 to 57.5) |
Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.
| titer | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat | 2004.5 (1680.1 to 2391.5) | 42.8 (31.7 to 57.9) |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: VRC-CHKVLP059-00-VP 20 mcg | 0/197 (0%) | 4/197 (2%) | 123/197 (62.4%) |
| Group 2: Placebo (VRC-PBSPLA043-00-VP) | 0/198 (0%) | 11/198 (5.6%) | 128/198 (64.6%) |
| Event | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 1/197 | 0/198 |
| AppendicectomySurgical and medical procedures | 1/197 | 0/198 |
| PyelonephritisInfections and infestations | 1/197 | 0/198 |
| ColitisGastrointestinal disorders | 1/197 | 0/198 |
| Femur fractureInjury, poisoning and procedural complications | 0/197 | 1/198 |
| Polycystic ovariesReproductive system and breast disorders | 0/197 | 1/198 |
| AppendicitisInfections and infestations | 0/197 | 1/198 |
| Acute hepatitis BInfections and infestations | 0/197 | 1/198 |
| Wolff-Parkinson-White syndromeCardiac disorders | 0/197 | 1/198 |
| Near drowningInjury, poisoning and procedural complications | 0/197 | 1/198 |
| Event | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) |
|---|---|---|
| Administration Site Pain/TendernessGeneral disorders | 61/197 | 37/198 |
| HeadacheNervous system disorders | 54/197 | 58/198 |
| MalaiseGeneral disorders | 53/197 | 48/198 |
| MyalgiaMusculoskeletal and connective tissue disorders | 46/197 | 36/198 |
| AnaemiaBlood and lymphatic system disorders | 20/197 | 29/198 |
| Joint PainMusculoskeletal and connective tissue disorders | 24/197 | 14/198 |
| ChillsGeneral disorders | 17/197 | 12/198 |
| NauseaGastrointestinal disorders | 11/197 | 16/198 |
| Upper Respiratory Tract InfectionInfections and infestations | 12/197 | 13/198 |
| BradycardiaCardiac disorders | 5/197 | 11/198 |
Population includes all enrolled subjects.
| Age, Customized(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| 18-20 years | 16 | 9 | 25 |
| 21-30 years | 66 | 75 | 141 |
| 31-40 years | 53 | 51 | 104 |
| 41-50 years | 40 | 34 | 74 |
| 51-60 years | 26 | 30 | 56 |
| Sex: Female, Male(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| Female | 96 | 103 | 199 |
| Male | 105 | 96 | 201 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| Hispanic or Latino | 137 | 138 | 275 |
| Not Hispanic or Latino | 64 | 61 | 125 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| North, South or Central American Native | 144 | 143 | 287 |
| Asian | 0 | 1 | 1 |
| Black or African American | 3 | 6 | 9 |
| White | 20 | 14 | 34 |
| More than one race | 21 | 20 | 41 |
| Unknown or Not Reported | 13 | 15 | 28 |
| Region of Enrollment(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| Haiti | 32 | 30 | 62 |
| Puerto Rico | 85 | 87 | 172 |
| Guadeloupe | 16 | 14 | 30 |
| Dominican Republic | 53 | 53 | 106 |
| Martinique | 15 | 15 | 30 |
| Body Mass Index (BMI)(Participants) | Group 1: VRC-CHKVLP059-00-VP 20 mcg | Group 2: Placebo (VRC-PBSPLA043-00-VP) | Total |
|---|---|---|---|
| under 18.5 kg/m^2 | 5 | 5 | 10 |
| 18.5-24.9 kg/m^2 | 94 | 93 | 187 |
| 25.0-29.9 kg/m^2 | 56 | 57 | 113 |
| 30.0 kg/m^2 or over | 45 | 44 | 89 |
| Missing | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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National Institute of Allergy and Infectious Diseases (NIAID) →