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This was a multicenter, randomized study to evaluate the safety, immunogenicity, and efficacy of VRC-ZKADNA090-00-VP (Zika virus wildtype DNA vaccine) or placebo. In Part A, the primary objective was to evaluate the safety and tolerability of the vaccine in different vaccination regimens. In Part B, the primary objectives were to evaluate the safety and efficacy of the vaccine compared to placebo.
This was a multicenter, randomized study to evaluate safety, immunogenicity, and efficacy of a 3-dose vaccination regimen with the Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP) or placebo (VRC-PBSPLA043-00-VP). The placebo was a sterile phosphate-buffered saline (PBS). The hypotheses were that the ZIKVwt DNA vaccine would be safe and would elicit a ZIKV-specific immune response.
Participants received study product intramuscularly (IM) in the limbs as specified by the group assignment by PharmaJet needle-free device. In Part A, 90 participants were randomized to vaccine at a 1:1:1 ratio to receive a 4 mg dose split between 2 injections, 4 mg dose split between 4 injections or 8 mg dose split between 4 injections. In Part B, 2338 participants were randomized to vaccine or placebo in a 1:1 ratio to receive a 4 mg (1 mL) dose of vaccine or 1 mL of placebo split between 2 injections. The vaccine dose and administration plan for Part B was selected based on Part A and Phase 1 data.
Vaccine safety and tolerability were assessed by monitoring of clinical and laboratory parameters throughout the study. Solicited reactogenicity symptoms were collected for 7 days after each product administration. The study schedule included clinic visits with safety and immunogenicity blood samples collected at particular time points.
Vaccine efficacy was evaluated in Part B by comparing incidence of virologic ZIKV cases between vaccine and placebo groups. During the study, when participants exhibited any possible symptom of ZIKV infection, they were evaluated by blood and urine ZIKV polymerase chain reaction (PCR). Stored blood samples were also assessed retrospectively by ZIKV PCR to identify possible asymptomatic cases. A Data and Safety Monitoring Board (DSMB) oversaw the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 injections | Experimental | Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device |
|
| Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 injections | Experimental | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device |
|
| Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 injections | Experimental | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device |
|
| Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 injections | Experimental | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device |
|
| Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC-ZKADNA090-00-VP | Biological | VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Participants 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. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | 7 days after each product administration |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Participants 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. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than once at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | 7 days after each product administration |
| Number of Participants With Abnormal Laboratory Measures of Safety (Part A) | Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 6, 8, 10, 12, and 16. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. |
| Measure | Description | Time Frame |
|---|---|---|
| Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A) | Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize eighty percent of infection events (EC80). | Day 0 to 28 days after the third product administration |
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Inclusion Criteria:
A participant must meet all of the following criteria:
Part A:
Part B:
Part A and B:
Laboratory Criteria within 56 days prior to randomization:
Criteria applicable to women and adolescents of childbearing potential:
Criteria applicable to adolescents:
Exclusion Criteria:
Criteria applicable to women and adolescents of childbearing potential:
• Breast-feeding or planning to become pregnant while participating through 12 weeks after the last product administration
Participant has received any of the following:
Participant has any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Ledgerwood, DO | VRC, NIAID, NIH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS-Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Doctors Hospital at Renaissance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21398392 | Background | Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS; VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011 May 15;203(10):1396-404. doi: 10.1093/infdis/jir054. Epub 2011 Mar 11. | |
| 18190252 |
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Part A targeted healthy adults only. Part B included adolescents in the study population. Part B sites had the option to enroll adolescents and adults, or choose to enroll only adults. The study was conducted at sites located in areas of confirmed or projected active transmission of Zika virus (ZIKV) infection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 11, 2019 |
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Part A participants (n=90) were randomized to study groups at a 1:1:1 ratio to receive a 4 mg or 8 mg dose of vaccine split between 2 or 4 injections. In Part B, participants (n=2338) were randomized to vaccine or placebo in a 1:1 ratio to receive a 4 mg (1 mL) dose of vaccine or 1 mL of placebo split between 2 injections. The vaccine dose and number of injections in Part B was determined by preliminary data from the Phase 1 trial and from Part A.
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Part A was open-label. For Part A, the participant, investigator and outcome assessor knew what the participant received.
Part B injections were prepared by an unblinded site pharmacist or designee who was not involved in any participant assessments and did not discuss randomizations with study clinicians. Participants, study personnel, site data entry personnel, and laboratory personnel performing immunologic assays were blinded to the treatment assignment of all product administrations. The investigational new drug (IND) Sponsor unblinded treatment assignments for Part B at the end of the study.
| Placebo Comparator |
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device |
|
| VRC-PBSPLA043-00-VP | Other | A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
|
|
| Day 0 after first product administration through Day 112 |
| Number of Participants With Abnormal Laboratory Measures of Safety (Part B) | Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 8, 16, and 44. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. | Day 0 after first product administration through Day 308 |
| Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A) | Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 224 are summarized. 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. | Day 0 through Day 224 |
| Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B) | Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 672 are summarized. 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. | Day 0 through Day 672 |
| Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A) | New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 224.The relationship between a chronic medical condition 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. | Day 0 through Day 224 |
| Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B) | New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 672.The relationship between a chronic medical condition 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. | Day 0 through Day 672 |
| Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B) | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the one month visit that followed the last study product administration (Visit 05), 84 days for both Parts A and B for participants who received all three study product administrations. If a participant received the first and second product administrations but not the third, then the time frame was through 56 days (Visit 04). If a participant only received the first product administration but not the second or third, then the time frame was through 28 days (Visit 03). The relationship between an AE 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 participant with multiple experiences of the same event is counted once using the event of worst severity. | Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and B |
| Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Virologically confirmed Zika infection, irrespective of symptoms, by polymerase chain reaction (PCR) in blood or in urine were recorded from receipt of first study product administration through the last expected study visit. | Day 0 through Day 672 |
| Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A) |
A participant was a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater. |
| Day 0 to 28 days after the third product administration |
| Number of Participants With Subclinical Cases of ZIKV (Part B Only) | Virologically confirmed cases of Zika infection without clinical signs or symptoms were recorded from receipt of first study product administration through the last expected study visit by PCR virus detection in blood of participants at regularly defined intervals. Subclinical cases of ZIKV infection were identified by retrospective PCR. | Day 0 through Day 672 |
| Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B) | Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize fifty percent of infection events (EC50). | Day 0 to 28 days after the third product administration |
| Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B) | A participant is a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater. | Day 0 to 28 days after the third product administration |
| Edinburg |
| Texas |
| 78539 |
| United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Hospital Das Clinicas Da Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Centro de Pesquisas ClÃnicas Do Instituto Central Do Hospital Das ClÃnicas Da FMUSP | São Paulo | São Paulo | 05403-010 | Brazil |
| Clinica de la Costa Ltda | Barranquilla | Atlántico | 080020 | Colombia |
| Centro de Atencion y Diagnostico de Enfermedades Infecciosas | Bucaramanga | Santander Department | 680003 | Colombia |
| CCIM Costa Rican Center Center of Medical Research, Sociedad Anonima | San José | Los Yoses | Costa Rica |
| AGA Clinical Centro de Investigaciones | Guayaquil | Guayas | 090506 | Ecuador |
| Hospital Civil Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| Instituto Conmemorativo Gorgas | Panama City | San Miguelito Province | Panama |
| Asociacion Civil Selva Amazonica | Iquitos | Maynas/Loreto | 16001 | Peru |
| Unidad de Ensayos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos | Lima | 15081 | Peru |
| Ponce Medical School Foundation Inc./CAIMED Center | Ponce | 00716 | Puerto Rico |
| Fundación de Investigación de Diego | San Juan | 00927 | Puerto Rico |
| San Juan Hospital Research Unit | San Juan | 00935 | Puerto Rico |
| Puerto Rico Clinical and Translational Research Consortium | San Juan | 00936-5067 | Puerto Rico |
| Background |
| Martin JE, Pierson TC, Hubka S, Rucker S, Gordon IJ, Enama ME, Andrews CA, Xu Q, Davis BS, Nason M, Fay M, Koup RA, Roederer M, Bailer RT, Gomez PL, Mascola JR, Chang GJ, Nabel GJ, Graham BS. A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial. J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650. |
| 27708058 | Background | Dowd KA, Ko SY, Morabito KM, Yang ES, Pelc RS, DeMaso CR, Castilho LR, Abbink P, Boyd M, Nityanandam R, Gordon DN, Gallagher JR, Chen X, Todd JP, Tsybovsky Y, Harris A, Huang YS, Higgs S, Vanlandingham DL, Andersen H, Lewis MG, De La Barrera R, Eckels KH, Jarman RG, Nason MC, Barouch DH, Roederer M, Kong WP, Mascola JR, Pierson TC, Graham BS. Rapid development of a DNA vaccine for Zika virus. Science. 2016 Oct 14;354(6309):237-240. doi: 10.1126/science.aai9137. Epub 2016 Sep 22. |
| 29217376 | Background | Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2018 Feb 10;391(10120):552-562. doi: 10.1016/S0140-6736(17)33105-7. Epub 2017 Dec 5. |
| FG001 | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| FG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| FG003 | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| FG004 | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
| Received First Product Administration |
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| Received Second Product Administration |
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| Received Third Product Administration |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| BG001 | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| BG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| BG003 | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| BG004 | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
| BG005 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Participants 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. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized. | Posted | Count of Participants | Participants | 7 days after each product administration |
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| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Participants 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. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than once at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). | All randomized participants in the study who received at least one study product administration with available data for at least one post-administration assessment for the symptom being summarized. | Posted | Count of Participants | Participants | 7 days after each product administration |
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| Primary | Number of Participants With Abnormal Laboratory Measures of Safety (Part A) | Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 6, 8, 10, 12, and 16. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 after first product administration through Day 112 |
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| Primary | Number of Participants With Abnormal Laboratory Measures of Safety (Part B) | Any abnormal laboratory results recorded as unsolicited AEs are summarized. Safety laboratory parameters included: alanine aminotransferase (ALT), white blood cells (WBC), red blood cells (RBC), hemoglobin, hematocrit, mean corpuscular volume (MCV), platelets, neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Laboratory safety evaluations were scheduled at baseline and weeks 4, 8, 16, and 44. Institutional laboratory normals as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 after first product administration through Day 308 |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A) | Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 224 are summarized. 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. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 through Day 224 |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B) | Any SAEs recorded from receipt of first study product administration through the last expected study visit at Day 672 are summarized. 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. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 through Day 672 |
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| Primary | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A) | New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 224.The relationship between a chronic medical condition 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. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 through Day 224 |
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| Primary | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B) | New onset chronic medical conditions were reported from receipt of first study product administration through the last expected study visit at Day 672.The relationship between a chronic medical condition 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. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 through Day 672 |
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| Primary | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B) | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the one month visit that followed the last study product administration (Visit 05), 84 days for both Parts A and B for participants who received all three study product administrations. If a participant received the first and second product administrations but not the third, then the time frame was through 56 days (Visit 04). If a participant only received the first product administration but not the second or third, then the time frame was through 28 days (Visit 03). The relationship between an AE 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 participant with multiple experiences of the same event is counted once using the event of worst severity. | All randomized participants in the study who received at least one study product administration, and had at least one post-administration safety assessment, analyzed according to the study product received. | Posted | Count of Participants | Participants | Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and B |
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| Primary | Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Virologically confirmed Zika infection, irrespective of symptoms, by polymerase chain reaction (PCR) in blood or in urine were recorded from receipt of first study product administration through the last expected study visit. | All randomized participants in the study, analyzed according to the randomized study product. One placebo participant, who had a virologically confirmed case of ZIKV from a sample collected prior to first product administration, is not counted as a virologically confirmed case. | Posted | Count of Participants | Participants | Day 0 through Day 672 |
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| Secondary | Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A) | Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize eighty percent of infection events (EC80). | All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0 to 28 days after the third product administration |
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| Secondary | Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A) | A participant was a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater. | All randomized participants, analyzed according to the randomized study product. All participants with samples at the protocol-defined immunogenicity timepoint were analyzed. The two subjects missing from Group 1 missed their Day 28 visit and thus there was no sample to analyze. | Posted | Count of Participants | Participants | Day 0 to 28 days after the third product administration |
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| Secondary | Number of Participants With Subclinical Cases of ZIKV (Part B Only) | Virologically confirmed cases of Zika infection without clinical signs or symptoms were recorded from receipt of first study product administration through the last expected study visit by PCR virus detection in blood of participants at regularly defined intervals. Subclinical cases of ZIKV infection were identified by retrospective PCR. | All randomized participants in the study, analyzed according to the randomized study product. One placebo participant had a subclinical case of ZIKV from a sample collected prior to first product administration. Two placebo participants had subclinical cases of ZIKV but also reported symptomatic ZIKV cases close in time to the positive subclinical result, consistent with a clinical picture of one symptomatic ZIKV infection event for each. These 3 are not counted as subclinical cases. | Posted | Count of Participants | Participants | Day 0 through Day 672 |
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| Secondary | Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B) | Antibody response as measured by ZIKV neutralization antibody (NAb) assay. Neutralizing activity is reported as the dilution of sera required to neutralize fifty percent of infection events (EC50). | Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0 to 28 days after the third product administration |
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| Secondary | Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B) | A participant is a responder or met the threshold of a positive response if the post vaccination anti-ZIKV antibody titer was 30 or greater. | Subset of per protocol population, which included randomly selected study participants who received three administrations within window as assigned by the randomization schedule and did not have any other major protocol deviations prior to their Week 12 visit, was analyzed to meet statistical power. | Posted | Count of Participants | Participants | Day 0 to 28 days after the third product administration |
|
Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the one month visit that followed the last product administration. At other time periods, only SAEs, new chronic medical conditions and confirmed cases of Dengue (DENV) infection were recorded through the last expected study visit (Part A: Day 224 and Part B: Day 672).
Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment were recorded for subjects who received at least one study injection and provided safety data following the injection, and represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
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 | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Zika virus wildtype (ZIKVwt) DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered intramuscularly (IM) by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV | 1 | 30 | 1 | 30 | 28 | 30 |
| EG001 | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV | 0 | 30 | 2 | 30 | 29 | 30 |
| EG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV | 0 | 30 | 0 | 30 | 30 | 30 |
| EG003 | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV | 1 | 1,162 | 17 | 1,162 | 990 | 1,162 |
| EG004 | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo | 0 | 1,161 | 18 | 1,161 | 859 | 1,161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 23.0 | Non-systematic Assessment | The congenital anomaly/birth defects were in the offspring of the participant. |
|
| Congenital hydronephrosis | Congenital, familial and genetic disorders | MedDRA 23.0 | Non-systematic Assessment | The congenital anomaly/birth defects were in the offspring of the participant. |
|
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Mucinous cystadenocarcinoma ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | 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 |
| |
| Leukocytosis | 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 |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Administration site erythema | General disorders | MedDRA 23.0 | Systematic Assessment | Redness |
|
| Administration site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Administration site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment | Joint Pain |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment | Fever (Temperature) |
|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VRC Clinical Trials Program Leadership | Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health | 301-451-8715 | ctpleadership@mail.nih.gov |
| Aug 19, 2020 |
| Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
| 18-20 years |
|
| 21-30 years |
|
| 31-35 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
| Mild |
|
| Moderate |
|
| Severe |
|
| Swelling |
|
| Redness |
|
| Any Local Symptom |
|
| OG001 | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG003 | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG004 | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
|
|
ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
|
|
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
|
|
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
|
|
|
|
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
|
|
|
|
| OG001 | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG003 | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 4 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
| OG004 | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
|
|
|
|
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
|
|
| OG002 | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | ZIKVwt DNA vaccine (VRC-ZKADNA090-00-VP), in 4 limbs (both arms and legs) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 8 mg of vaccine administered IM by a needle-free injection device VRC-ZKADNA090-00-VP: VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV |
|
|
Sterile phosphate-buffered saline (PBS) (VRC-PBSPLA043-00-VP), the placebo, in 2 limbs (both arms) on Day 0, Day 28 (+/-7 days), and Day 56 (-7/+14 days); 1 mL of placebo administered IM by a needle-free injection device VRC-PBSPLA043-00-VP: A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo |
|
|
|
|
|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|