VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents

VRC 705: A Phase 2/2B, Randomized Trial to Evaluate the Safety, Immunogenicity and Efficacy of a Zika Virus DNA Vaccine in Healthy Adults and Adolescents

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03110770

Acronym

DNA

Enrollment

2428

Registered

2017-04-12

Start date

2017-03-29

Completion date

2019-10-04

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flaviviral Diseases, Flaviviridae Infections, Flavivirus Infections, RNA Virus Infections, Virus Diseases, Zika Virus, Zika Virus Infection

Keywords

Flavivirus, Zika, Vaccine, Physiological Effects of Drugs, Immunologic Factors, Virus-like Particles, Zika vaccine

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALVRC-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

OTHERVRC-PBSPLA043-00-VP

A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

15 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

A participant must meet all of the following criteria: Part A: * 18 to 35 years of age * Available for clinical follow-up through Study Week 32 * Accessible injection sites on each limb as follows: 1 injection site in the deltoid muscle of each arm and 1 injection site in the vastus lateralis muscle of each anterolateral thigh Part B: * 15 to 35 years of age * Available for clinical follow-up through Study Week 96 * Accessible injection sites on the deltoid muscle of each arm. Injection in the vastus lateralis muscle of the anterolateral thighs may have been allowed with IND Sponsor approval if an injection site on each deltoid muscle was not available. Part A and B: * Able to provide proof of identity to the satisfaction of the clinician completing the enrollment process * Able and willing to complete the informed consent/assent process * Able and willing to complete the Assessment of Understanding and to verbalize understanding of all questions answered incorrectly prior to signing consent/assent * Willing to donate blood and urine to be stored and used for future research * In good general health without clinically significant medical history * Physical examination and laboratory results without clinically significant findings within the 56 days prior to randomization * Weight \>30 kilograms (kg) * Agree not to receive any licensed or investigational flavivirus vaccines through 4 weeks after last product administration Laboratory Criteria within 56 days prior to randomization: * Hemoglobin within site institutional normal limits * Absolute neutrophil count (ANC) within site institutional normal limits * Total lymphocyte count ≥800 cells/mm\^3 * Platelets = 125,000-510,000 cells/mm\^3 * Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN) based on site institutional normal range for respective age group * Serum creatinine ≤1.2 x ULN based on site institutional normal range for respective age group * Negative result on a human immunodeficiency virus (HIV) test that meets local standards for identification of HIV infection Criteria applicable to women and adolescents of childbearing potential: * Negative result on a human chorionic gonadotropin pregnancy test (urine or serum) on day of randomization before receiving study product * Agree to use effective means of birth control from at least 21 days before randomization through 12 weeks after the last product administration Criteria applicable to adolescents: * Capability of the parent/guardian of the minor to understand and comply with planned study procedures * Capability of the minor and their parent/guardian to provide informed consent/assent

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: * More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to randomization * Any systemic immunosuppressive medications or cytotoxic medications within the 14 days prior to randomization * Blood products within 16 weeks prior to randomization * Immunoglobulin within 8 weeks prior to randomization * Investigational research agents within 4 weeks prior to randomization or planning to receive investigational products while on the study * Any vaccination within 2 weeks prior to randomization * Any live attenuated vaccination within 4 weeks prior to randomization * Current anti-tuberculosis (TB) prophylaxis or therapy Participant has any of the following: * Confirmed history of ZIKV infection (as reported by participant) * Serious reactions to vaccines * Chronic angioedema or chronic urticaria * Asthma that is not well-controlled * Diabetes mellitus (type I or II) * Clinically significant autoimmune disease or immunodeficiency * Hypertension that is not well-controlled * Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) * Significant bruising or bleeding difficulties with IM injections or blood draws * Malignancy that is active or history of a malignancy that is likely to recur during the period of the study * Seizure or treatment for a seizure disorder within the last 3 years * Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen * History of Guillain-Barré Syndrome * Psychiatric condition that may preclude compliance with the protocol; past or present psychoses; or a history of suicide plan or attempt within 5 years prior to randomization * Any medical psychiatric, or social condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 0 to 28 days after the third product administration	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).
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 0 to 28 days after the third product administration	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.
Number of Participants With Subclinical Cases of ZIKV (Part B Only)	Day 0 through Day 672	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.
Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)	Day 0 to 28 days after the third product administration	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).
Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)	Day 0 to 28 days after the third product administration	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.

Countries

Brazil, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Puerto Rico, United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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	30
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	30
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	30
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	1,170
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	1,168
Total	2,428

Withdrawals & dropouts

Period	Reason	FG000	FG002	FG003	FG004
Overall Study	Death	1	0	1	0
Overall Study	Enrolled but did not receive product	0	0	8	7
Overall Study	Illness/Injury unrelated to product	0	0	0	1
Overall Study	Investigator Decision	0	0	5	3
Overall Study	Lost to Follow-up	0	0	53	45
Overall Study	Moved from area	5	2	42	43
Overall Study	Withdrawal by Subject	0	0	24	24

Baseline characteristics

Characteristic	Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Total
Age, Customized 15-17 years	NA Participants	NA Participants	NA Participants	17 Participants	17 Participants	NA Participants
Age, Customized 18-20 years	0 Participants	0 Participants	2 Participants	223 Participants	222 Participants	447 Participants
Age, Customized 21-30 years	19 Participants	24 Participants	22 Participants	740 Participants	734 Participants	1539 Participants
Age, Customized 31-35 years	11 Participants	6 Participants	6 Participants	190 Participants	195 Participants	408 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants	18 Participants	17 Participants	1150 Participants	1139 Participants	2339 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants	12 Participants	13 Participants	17 Participants	25 Participants	82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants	7 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants	7 Participants	5 Participants	6 Participants	6 Participants	30 Participants
Race (NIH/OMB) Asian	4 Participants	2 Participants	1 Participants	2 Participants	3 Participants	12 Participants
Race (NIH/OMB) Black or African American	4 Participants	2 Participants	2 Participants	52 Participants	41 Participants	101 Participants
Race (NIH/OMB) More than one race	3 Participants	4 Participants	5 Participants	834 Participants	837 Participants	1683 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	5 Participants	3 Participants	8 Participants
Race (NIH/OMB) White	13 Participants	15 Participants	17 Participants	270 Participants	278 Participants	593 Participants
Sex: Female, Male Female	14 Participants	22 Participants	13 Participants	595 Participants	601 Participants	1245 Participants
Sex: Female, Male Male	16 Participants	8 Participants	17 Participants	575 Participants	567 Participants	1183 Participants
Weight	86.31 kilograms STANDARD_DEVIATION 28.22	79.57 kilograms STANDARD_DEVIATION 19.84	78.55 kilograms STANDARD_DEVIATION 23.82	70.80 kilograms STANDARD_DEVIATION 16.94	70.05 kilograms STANDARD_DEVIATION 17.49	70.84 kilograms STANDARD_DEVIATION 17.65

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	1 / 30	0 / 30	0 / 30	1 / 1,162	0 / 1,161
other Total, other adverse events	28 / 30	29 / 30	30 / 30	990 / 1,162	859 / 1,161
serious Total, serious adverse events	1 / 30	2 / 30	0 / 30	17 / 1,162	18 / 1,161

Outcome results

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).

Time frame: 7 days after each product administration

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Moderate	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Mild	4 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	None	26 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	None	5 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	None	24 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Moderate	4 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Mild	21 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	None	5 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Mild	21 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Moderate	1 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Moderate	4 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Mild	5 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	None	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Mild	21 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Moderate	7 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	None	25 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Mild	5 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Moderate	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	None	26 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Mild	3 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Moderate	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	None	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Mild	20 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Moderate	8 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	None	23 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Mild	14 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Moderate	14 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	None	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Mild	14 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	None	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Moderate	14 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	None	23 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Moderate	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Mild	6 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Mild	7 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Mild	600 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Moderate	12 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Severe	5 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Severe	0 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	None	1037 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Moderate	268 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Mild	103 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Mild	82 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Moderate	13 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Severe	0 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	None	282 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	None	291 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Severe	5 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Mild	598 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	None	1059 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Moderate	257 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	None	552 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Mild	485 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Moderate	107 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Mild	52 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Severe	0 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Mild	482 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	None	1124 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Severe	4 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	Moderate	96 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	None	1085 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Mild	22 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Severe	0 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Pain/Tenderness	None	566 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Local Symptom	Severe	4 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Redness	Moderate	11 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Swelling	Moderate	2 Participants

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).

Time frame: 7 days after each product administration

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Moderate	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Mild	8 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Moderate	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Mild	3 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	None	20 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	None	16 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Moderate	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Mild	8 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Mild	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	None	30 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Mild	3 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Mild	10 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	None	27 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Moderate	1 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Moderate	4 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Moderate	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Mild	3 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	None	20 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	None	26 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Moderate	1 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Moderate	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Mild	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	None	26 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Severe	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	None	26 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	None	23 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Mild	3 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Moderate	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Mild	12 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Moderate	4 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Severe	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Mild	6 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Moderate	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	None	15 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Mild	13 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Moderate	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	None	25 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Mild	4 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Moderate	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	None	20 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Mild	6 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Moderate	3 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Severe	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	None	22 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	None	26 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Moderate	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Mild	5 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Moderate	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	None	30 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Mild	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Severe	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	None	13 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Mild	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Mild	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	None	17 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Mild	12 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Moderate	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Moderate	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	None	20 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Mild	8 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	None	26 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Mild	4 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	None	28 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Moderate	3 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	None	8 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Mild	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Mild	19 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Mild	13 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	None	17 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	None	29 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Moderate	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Severe	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	None	29 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Severe	4 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Severe	1 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	None	696 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	None	971 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Mild	136 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Severe	14 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Mild	320 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Moderate	44 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Severe	2 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Moderate	210 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	None	508 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	None	964 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	None	1015 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Moderate	131 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Mild	149 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Severe	4 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	None	1090 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Moderate	36 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	None	748 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Moderate	86 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Mild	37 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Mild	421 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Mild	306 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Moderate	22 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Moderate	97 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Mild	109 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Severe	4 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Severe	2 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Severe	6 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	None	793 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Moderate	28 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Mild	270 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Mild	394 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	None	713 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Severe	4 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Severe	2 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Mild	84 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Moderate	24 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Severe	11 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Moderate	77 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	None	991 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Severe	22 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Severe	13 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	None	542 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Mild	118 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	Mild	31 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Severe	2 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	None	1029 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Moderate	41 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Moderate	34 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Mild	298 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Fever	None	1082 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	Mild	227 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Nausea	Severe	5 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Any Systemic Symptom	Moderate	190 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	None	772 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Moderate	86 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Severe	4 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	None	982 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Myalgia	None	842 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Chills	Moderate	33 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Headache	Moderate	124 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Malaise	Mild	286 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)	Joint Pain	Mild	121 Participants

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.

Time frame: Day 0 after first product administration through Day 112

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Hemoglobin	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Eosinophil	1 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Neutrophil	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Platelets	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	WBC	2 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	ALT	3 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Lymphocyte	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Eosinophil	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	ALT	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	WBC	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Hemoglobin	2 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Platelets	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Neutrophil	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Lymphocyte	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	ALT	3 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Neutrophil	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	WBC	3 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Eosinophil	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Lymphocyte	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Platelets	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part A)	Hemoglobin	2 Participants

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.

Time frame: Day 0 after first product administration through Day 308

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Platelets	7 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	ALT	87 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Neutrophil	19 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Lymphocyte	13 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Hemoglobin	49 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Eosinophil	72 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	WBC	53 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Eosinophil	68 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	ALT	90 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	WBC	70 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Hemoglobin	53 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Platelets	3 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Lymphocyte	6 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Abnormal Laboratory Measures of Safety (Part B)	Neutrophil	15 Participants

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.

Time frame: Day 0 through Day 224

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Unrelated to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Unrelated to Study Product	1 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)	Unrelated to Study Product	0 Participants

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.

Time frame: Day 0 through Day 672

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)	Unrelated to Study Product	15 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)	Related to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)	Related to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)	Unrelated to Study Product	9 Participants

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.

Time frame: Day 0 through the one month visit that follows the last product administration (Visit 05), 84 days for both Parts A and B

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Related to Study Product	4 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Unrelated to Study Product	18 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Related to Study Product	5 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Unrelated to Study Product	14 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Related to Study Product	6 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Unrelated to Study Product	20 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Unrelated to Study Product	500 Participants
Part B, Group 4: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Related to Study Product	77 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Related to Study Product	58 Participants
Part B, Group 5: Placebo (VRC-PBSPLA043-00-VP), 2 Injections	Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)	Unrelated to Study Product	530 Participants

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.

Time frame: Day 0 through Day 224

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Unrelated to Study Product	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Unrelated to Study Product	2 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Related to Study Product	0 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)	Unrelated to Study Product	0 Participants

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.

Time frame: Day 0 through Day 672

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)	Related to Study Product	0 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)	Unrelated to Study Product	17 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)	Related to Study Product	0 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)	Unrelated to Study Product	18 Participants

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.

Time frame: Day 0 through Day 672

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only)	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only)	2 Participants

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.

Time frame: Day 0 to 28 days after the third product administration

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 0 (Baseline, Pre-administration)	5 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 28 After the Third Product Administration	20 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 0 (Baseline, Pre-administration)	8 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 28 After the Third Product Administration	27 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 0 (Baseline, Pre-administration)	4 Participants
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)	Day 28 After the Third Product Administration	29 Participants

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.

Time frame: Day 0 to 28 days after the third product administration

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)	Day 0 (Baseline, Pre-administration)	80 Participants
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)	Day 28 After the Third Product Administration	139 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)	Day 0 (Baseline, Pre-administration)	35 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)	Day 28 After the Third Product Administration	35 Participants

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.

Time frame: Day 0 through Day 672

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Number of Participants With Subclinical Cases of ZIKV (Part B Only)	1 Participants
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Number of Participants With Subclinical Cases of ZIKV (Part B Only)	0 Participants

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).

Time frame: Day 0 to 28 days after the third product administration

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 0 (Baseline, Pre-administration)	22.288 titer
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 28 After the Third Product Administration	77.468 titer
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 0 (Baseline, Pre-administration)	34.836 titer
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 28 After the Third Product Administration	187.629 titer
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 0 (Baseline, Pre-administration)	22.25 titer
Part A, Group 3: VRC-ZKADNA090-00-VP (8 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)	Day 28 After the Third Product Administration	130.497 titer

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).

Time frame: Day 0 to 28 days after the third product administration

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)	Day 0 (Baseline, Pre-administration)	94.7 titer
Part A, Group 1: VRC-ZKADNA090-00-VP (4 mg), 2 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)	Day 28 After the Third Product Administration	567.7 titer
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)	Day 0 (Baseline, Pre-administration)	205.3 titer
Part A, Group 2: VRC-ZKADNA090-00-VP (4 mg), 4 Injections	Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)	Day 28 After the Third Product Administration	191.9 titer

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026

VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents

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Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)

Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After Each Product Administration (Part A and Part B)

Number of Participants With Abnormal Laboratory Measures of Safety (Part A)

Number of Participants With Abnormal Laboratory Measures of Safety (Part B)

Number of Participants With New Chronic Medical Conditions Following Product Administration (Part A)

Number of Participants With New Chronic Medical Conditions Following Product Administration (Part B)

Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration (Part A and Part B)

Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part A)

Number of Participants With Serious Adverse Events (SAEs) Following Product Administration (Part B)

Number of Participants With Virologically Confirmed Cases of ZIKV (Part B Only)

Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part A)

Number of Participants With Positive Response to Zika Antigen-specific Neutralizing Antibody (Part B)

Number of Participants With Subclinical Cases of ZIKV (Part B Only)

Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part A)

Zika Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - (Part B)