Trial · NCT03110770
VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents
NCT03110770, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2020-12-04
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ConductScience Library. VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents. Trials, record NCT03110770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03110770
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents
- NCT number
- NCT03110770
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2,428 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Zika Virus, Zika Virus Infection, Virus Diseases, Flavivirus Infections, Flaviviral Diseases, Flaviviridae Infections, RNA Virus Infections
- Interventions
- VRC-ZKADNA090-00-VP, VRC-PBSPLA043-00-VP
- First posted
- 2017-04-12
- Last updated
- 2024-01-31
- Results first posted
- 2020-12-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | 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). |
| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | 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). |
| Primary | Number of Participants With Abnormal Laboratory Measures of Safety (Part A) | Day 0 after first product administration through Day 112 | 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. |
| Primary | Number of Participants With Abnormal Laboratory Measures of Safety (Part B) | Day 0 after first product administration through Day 308 | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A) | Day 0 through Day 224 | 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. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B) | Day 0 through Day 672 | 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. |
| Primary | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A) | Day 0 through Day 224 | 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. |
| Primary | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B) | Day 0 through Day 672 | 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. |
| Primary | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B) | Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and 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. |
| Primary | Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Day 0 through Day 672 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | 7 days after each product administration | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Laboratory Measures of Safety (Part A) | Day 0 after first product administration through Day 112 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Laboratory Measures of Safety (Part B) | Day 0 after first product administration through Day 308 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A) | Day 0 through Day 224 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B) | Day 0 through Day 672 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A) | Day 0 through Day 224 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B) | Day 0 through Day 672 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B) | Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and B | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Day 0 through Day 672 | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group329
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Pain/Tenderness / None | 5 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | Pain/Tenderness / None | 2 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | Pain/Tenderness / None | 2 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Pain/Tenderness / None | 291 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Pain/Tenderness / None | 566 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Pain/Tenderness / Mild | 21 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | Pain/Tenderness / Mild | 21 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | Pain/Tenderness / Mild | 14 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | Pain/Tenderness / Mild | 600 | Participants | |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B) | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | Pain/Tenderness / Mild | 482 | Participants |
1 to 10 of 329Source ClinicalTrials.gov
See all 329 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 30 | |
| Overall Study | STARTED | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 30 | |
| Overall Study | STARTED | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 30 | |
| Overall Study | STARTED | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 1,170 | |
| Overall Study | STARTED | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 1,168 | |
| Overall Study | Received First Product Administration | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 30 | |
| Overall Study | Received First Product Administration | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 30 | |
| Overall Study | Received First Product Administration | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 30 | |
| Overall Study | Received First Product Administration | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 1,162 | |
| Overall Study | Received First Product Administration | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 1,161 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events290
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 2 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 2 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 2 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 51 | 1,162 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 56 | 1,161 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 2 | 30 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 1 | 30 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 1 | 30 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 49 | 1,162 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 67 | 1,161 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 1 | 30 |
| Total, all-cause mortality | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 0 | 30 |
| Total, all-cause mortality | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 0 | 30 |
| Total, all-cause mortality | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 1 | 1,162 |
| Total, all-cause mortality | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 0 | 1,161 |
| Total, other adverse events | Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 28 | 30 |
| Total, other adverse events | Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections | 29 | 30 |
| Total, other adverse events | Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections | 30 | 30 |
| Total, other adverse events | Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections | 990 | 1,162 |
| Total, other adverse events | Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections | 859 | 1,161 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections vs Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections: Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only) | Trial comparisons |
| Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections vs Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections: Number of Participants With Subclinical Cases of ZIKV (Part B Only) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03110770
GET https://conductscience.org/api/trials/v1/NCT03110770/results?page=2