Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Western Equine Encephalitis Virus (WEEV), Eastern Equine Encephalitis Virus (EEEV), and Venezuelan Equine Encephalitis Virus (VEEV) are transmitted to humans by infected mosquitoes and can cause encephalitis (swelling of the brain) and other neurological manifestations, including fever, chills, discomfort, feeling sick, muscle pain and then headache, vomiting, restlessness, irritability, seizures, coma, and death.
Vaccines teach the body to prevent or fight an infection. When the body learns to fight an infection, this is called an immune response. Researchers developed a vaccine against Western, Eastern and Venezuelan equine encephalitis viruses to help the body make an immune response. There are no live or killed viruses in the vaccine, so you cannot get infected with any of these 3 viruses from getting the vaccine.
The experimental trivalent encephalitis vaccine, VRC-WEVVLP073-00-VP, is composed of Western equine encephalitis (WEE), Eastern equine encephalitis (EEE), and Venezuelan equine encephalitis (VEE) virus-like particles (VLP).
The purpose of this study is to test three doses (6 mcg, 30 mcg, and 60 mcg) of this experimental vaccine against Western, Eastern and Venezuelan equine encephalitis viruses.
This is a Phase 1, randomized, open-label, dose-escalation study to examine the safety, tolerability, and immune response of three doses (6 mcg, 30 mcg, and 60 mcg) of the WEVEE vaccine (VRC-WEVVLP073-00-VP) alone or with alum adjuvant (VRC-GENMIX083-AL-VP) in a 2-product administration regimen.
Eligible subjects were randomized to WEVEE alone (Groups 1, 3, and 5) or WEVEE plus alum (Groups 2, 4, and 6, respectively) in each dose group. No more than 1 subject was randomized and vaccinated per day for the first 3 subjects at each dose. If the 6 mcg dose of WEVEE was assessed as not showing safety concerns by a Protocol Safety Review Team (PSRT), randomization began for Groups 3 and 4 (30 mcg WEVEE without alum and with alum, respectively). In a second safety review conducted on the first 3 subjects to receive 30 mcg, if the 30 mcg dose of WEVEE was assessed as not showing safety concerns by the PSRT, randomization began for Groups 5 and 6 (60 mcg WEVEE without and with alum, respectively).
The product was administered in the upper arm muscle as an intramuscular (IM) injection via needle and syringe at Day 0 and 8 weeks later.
For all groups, solicited reactogenicity was evaluated using a 7-day diary card. Assessment of vaccine safety included clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 6 mcg WEVEE vaccine | Experimental | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 |
|
| Group 2: 6 mcg WEVEE vaccine + alum | Experimental | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 |
|
| Group 3: 30 mcg WEVEE vaccine | Experimental | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 |
|
| Group 4: 30 mcg WEVEE vaccine + alum | Experimental | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 |
|
| Group 5: 60 mcg WEVEE vaccine | Experimental | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-WEVVLP073-00-VP | Biological | VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Local Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were 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. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (modified from FDA Guidance - September 2007). | 7 days after each product administration, at approximately Week 1 and Week 9 |
| Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were 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. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (modified from FDA Guidance - September 2007). | 7 days after each product administration, at approximately Week 1 and Week 9 |
| Number of Subjects With Abnormal Laboratory Measures of Safety | Any abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hemoglobin change from baseline, hematocrit, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC), differential, platelet, and ALT results were collected at screening (≤ 28 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 14, 28, 56, 70, 84, 168 and 252. Creatinine results were collected at screening, Day 0 and Day 56. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (modified from FDA Guidance, September 2007) were used. |
| Measure | Description | Time Frame |
|---|---|---|
| Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Last Product Administration of VRC-WEVVLP073-00-VP (WEVEE) Alone Or With Alum Adjuvant | WEVEE antigen-specific antibody responses as evaluated by virus-specific neutralization assays. Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV) and Western Equine Encephalitis Virus (WEEV) neutralizing titers were assessed using a plaque reduction neutralization test (PRNT) at baseline and 4 weeks after the second study injection. Geometric mean titers of the individual PRNT80 (80% plaque reduction neutralization) titer values are reported. |
Not provided
Inclusion Criteria:
A volunteer must have met all of the following criteria:
Laboratory Criteria within 28 days prior to randomization:
Criteria applicable to women of childbearing potential:
Exclusion Criteria:
A volunteer was excluded if one or more of the following conditions applied:
Female-Specific Criteria
• Breast-feeding or planning to become pregnant while participating in the study
Volunteer received any of the following:
Volunteer has a history of any of the following clinically significant conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie E Ledgerwood, DO | VRC/NIAID/NIH | Study Chair |
| Grace Chen, MD | VRC/NIAID/NIH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hope Clinic of the Emory Vaccine Center | Decatur | Georgia | 30030 | United States |
| 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. | |
| 20111039 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy subjects were enrolled at The Hope Clinic of the Emory Vaccine Center in Decatur, Georgia.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 6 mcg WEVEE Vaccine | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered intramuscularly (IM) on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| FG001 | Group 2: 6 mcg WEVEE Vaccine + Alum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Oct 24, 2019 |
Not provided
Subjects were randomized into:
WEVEE vaccine alone (Group 1, Group 3, and Group 5) or, WEVEE vaccine mixed with alum (Group 2, Group 4, and Group 6, respectively).
The study started by randomizing subjects to get a dose of 6 mcg in Group 1 or Group 2. Safety data were reviewed after 2 weeks to make sure this vaccine dose had no safety concerns before subjects were randomized to get the next dose of 30 mcg in Group 3 or Group 4. Safety data were reviewed again to make sure the 30 mcg vaccine dose had no safety concerns before subjects were randomized to the 60 mcg dose in Group 5 or Group 6.
A total of 30 subjects were randomized among the 6 groups.
Not provided
Not provided
Not provided
Not provided
| Group 6: 60 mcg WEVEE vaccine + alum | Experimental | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 |
|
|
| VRC-GENMIX083-AL-VP | Other | VRC-GENMIX083-AL-VP is an adjuvant |
|
|
| Day 0 through Day 252 |
| Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through 4 weeks of each study product administration, up to Week 12 |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs were reported from receipt of first study product administration through the last expected study visit at Day 252. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through Day 252 |
| 4 weeks after the last product administration, at Week 12 |
| Percentage of Positive Responders at 4 Weeks After the Last Product Administration of VRC-WEVVLP073-00-VP (WEVEE) Alone Or With Alum Adjuvant | A subject was a responder or met the threshold of a positive response if the post vaccination anti-Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV) or Western Equine Encephalitis Virus (WEEV) antibody titer was 10 or greater. | 4 weeks after the last product administration, at Week 12 |
| Background |
| Akahata W, Yang ZY, Andersen H, Sun S, Holdaway HA, Kong WP, Lewis MG, Higgs S, Rossmann MG, Rao S, Nabel GJ. A virus-like particle vaccine for epidemic Chikungunya virus protects nonhuman primates against infection. Nat Med. 2010 Mar;16(3):334-8. doi: 10.1038/nm.2105. Epub 2010 Jan 28. |
| 35568049 | Derived | Coates EE, Edupuganti S, Chen GL, Happe M, Strom L, Widge A, Florez MB, Cox JH, Gordon I, Plummer S, Ola A, Yamshchikov G, Andrews C, Curate-Ingram S, Morgan P, Nagar S, Collins MH, Bray A, Nguyen T, Stein J, Case CL, Kaltovich F, Wycuff D, Liang CJ, Carlton K, Vazquez S, Mascola JR, Ledgerwood JE; VRC 313 Study Team. Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial. Lancet Infect Dis. 2022 Aug;22(8):1210-1220. doi: 10.1016/S1473-3099(22)00052-4. Epub 2022 May 11. |
6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| FG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| FG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| FG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| FG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| Received First Product Administration |
|
| Received All Product Administrations |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Population includes all enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 6 mcg WEVEE Vaccine | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| BG001 | Group 2: 6 mcg WEVEE Vaccine + Alum | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| BG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| BG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| BG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| BG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| BG006 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 For 7 Days After Each Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were 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. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (modified from FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one study injection and provided safety data (via diary card and/or laboratory results) following the injection. | Posted | Count of Participants | Participants | 7 days after each product administration, at approximately Week 1 and Week 9 |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms For 7 Days After Each Product Administration | Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects were 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. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (modified from FDA Guidance - September 2007). | Population included all enrolled subjects who received at least one study injection and provided safety data (via diary card and/or laboratory results) following the injection. | Posted | Count of Participants | Participants | 7 days after each product administration, at approximately Week 1 and Week 9 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Abnormal Laboratory Measures of Safety | Any abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hemoglobin change from baseline, hematocrit, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC), differential, platelet, and ALT results were collected at screening (≤ 28 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 14, 28, 56, 70, 84, 168 and 252. Creatinine results were collected at screening, Day 0 and Day 56. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials (modified from FDA Guidance, September 2007) were used. | Population included all enrolled subjects who had laboratory results available at any study visit post baseline. | Posted | Count of Participants | Participants | Day 0 through Day 252 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received at least one study injection and provided safety data (via diary card and/or laboratory results) following the injection. | Posted | Count of Participants | Participants | Day 0 through 4 weeks of each study product administration, up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs were reported from receipt of first study product administration through the last expected study visit at Day 252. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A subject with multiple experiences of the same event is counted once using the event of worst severity. | Population included all enrolled subjects who received at least one study injection and provided safety data (via diary card and/or laboratory results) following the injection. | Posted | Count of Participants | Participants | Day 0 through Day 252 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Antigen-specific Neutralizing Antibody Geometric Mean Titers (GMTs) at 4 Weeks After the Last Product Administration of VRC-WEVVLP073-00-VP (WEVEE) Alone Or With Alum Adjuvant | WEVEE antigen-specific antibody responses as evaluated by virus-specific neutralization assays. Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV) and Western Equine Encephalitis Virus (WEEV) neutralizing titers were assessed using a plaque reduction neutralization test (PRNT) at baseline and 4 weeks after the second study injection. Geometric mean titers of the individual PRNT80 (80% plaque reduction neutralization) titer values are reported. | Subjects who received 2 study injections per protocol. One Group 1 subject received only one injection due to an unrelated AE of Neutropenia. | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks after the last product administration, at Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Positive Responders at 4 Weeks After the Last Product Administration of VRC-WEVVLP073-00-VP (WEVEE) Alone Or With Alum Adjuvant | A subject was a responder or met the threshold of a positive response if the post vaccination anti-Eastern Equine Encephalitis Virus (EEEV), Venezuelan Equine Encephalitis Virus (VEEV) or Western Equine Encephalitis Virus (WEEV) antibody titer was 10 or greater. | Subjects who received 2 study injections per protocol. One Group 1 subject received only one injection due to an unrelated AE of Neutropenia. | Posted | Number | percentage of responders | 4 weeks after the last product administration, at Week 12 |
|
Solicited adverse events (AEs) were reported for 7 days after each study 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 Day 252, only new chronic medical conditions were collected as unsolicited AEs. Serious AEs (SAEs) were reported from receipt of the first study injection through the last expected study visit at Day 252.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: 6 mcg WEVEE Vaccine | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) | 0 | 5 | 1 | 5 | 4 | 5 |
| EG001 | Group 2: 6 mcg WEVEE Vaccine + Alum | 6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant | 0 | 5 | 0 | 5 | 5 | 5 |
| EG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) | 0 | 5 | 0 | 5 | 4 | 5 |
| EG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant | 0 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious mononucleosis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment | Neutropenia and blood pressure increase for one Group 6 subject were assessed as related to study product. |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Administration site pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (23.0) | Non-systematic Assessment | Neutropenia and blood pressure increase for one Group 6 subject were assessed as related to study product. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (23.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie E. Ledgerwood, DO (Study Chair) | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-594-8502 | ledgerwood@mail.nih.gov |
| Apr 13, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D004685 | Encephalomyelitis, Venezuelan Equine |
| D020241 | Encephalomyelitis, Western Equine |
| D020242 | Encephalomyelitis, Eastern Equine |
| D018354 | Alphavirus Infections |
| ID | Term |
|---|---|
| D004683 | Encephalomyelitis, Equine |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004679 | Encephalomyelitis |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D004671 | Encephalitis, Arbovirus |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C041524 | aluminum sulfate |
Not provided
Not provided
Not provided
| 31-40 years |
|
| 41-50 years |
|
| Male |
|
| Black or African-American |
|
| White |
|
| Hispanic/Latino |
|
| Not Hispanic/Latino |
|
| 25.0-29.9 kg/m^2 |
|
| 30.0 kg/m^2 and over |
|
| OG006 | Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE | VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG007 | Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE + Alum | VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| Mild |
|
| Moderate |
|
| Severe |
|
| Swelling |
|
| Redness |
|
| Any Local Symptom |
|
| OG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG006 | Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE | VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG007 | Overall Incidence All Dosages (6, 30, and 60 mcg) WEVEE + Alum | VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8
VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)
VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant
| OG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
6 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8
VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)
VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant
| OG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
| OG002 | Group 3: 30 mcg WEVEE Vaccine | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG003 | Group 4: 30 mcg WEVEE Vaccine + Alum | 30 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
| OG004 | Group 5: 60 mcg WEVEE Vaccine | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) |
| OG005 | Group 6: 60 mcg WEVEE Vaccine + Alum | 60 mcg of WEVEE vaccine (VRC-WEVVLP073-00-VP) and 500 mcg of Alum (VRC-GENMIX083-AL-VP) administered IM on Day 0 and Week 8 VRC-WEVVLP073-00-VP: VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP) VRC-GENMIX083-AL-VP: VRC-GENMIX083-AL-VP is an adjuvant |
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|