Trial Outcomes & Findings for Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device (NCT NCT03682107)

NCT ID: NCT03682107

Last Updated: 2022-11-22

Results Overview

Laboratory parameters include alanine aminotransferase (ALT), total bilirubin, creatinine, blood urea nitrogen (BUN), hemoglobin, absolute neutrophil count (ANC), sodium, potassium, white blood cells (WBC), and platelet count. Laboratory results were considered adverse events using the following thresholds: ALT 50 IU/L or greater; total bilirubin 1.30 mg/dL or greater; creatinine 0.81 mg/dL or greater (female) or 1.11 mg/dL or greater (male); BUN 24 mg/dL or greater; hemoglobin 11.6 g/dL or lower (female) or 13.2 g/dL or lower (male); ANC \<1.8 K/mcL; sodium 135 mmol/L or lower (decrease) or 146 mmol/L or greater (increase); potassium 3.0 mmol/L or lower (decrease) or 5.2 mmol/L or greater (increase); WBC 4.4 K/mcL or lower (decrease) or 13.1 K/mcL or greater (increase 18 to \<21 years) and 11.1 K/mcL or greater (increase 21 years or older); or platelets 134 K/mcL or below (decrease) or 467 K/mcL or greater (increase).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 48 participants
• Primary outcome timeframe: Day 8, Day 36, Day 64, Day 176
• Results posted on: 2022-11-22

Participant Flow

The study population includes 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health, have not previously received the Hantavirus vaccine, have not been exposed to ANDV, and meet all other eligibility criteria. Participants were enrolled between 19FEB2019 and 04NOV2019 and received study vaccinations between 19FEB2019 and 08APR2020.

Participant milestones

Measure	2 mg ANDV, 3 Dose Regimen 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	2 mg ANDV, 4 Dose Regimen 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 3 Dose Regimen 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 4 Dose Regimen 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	Placebo 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner. Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
Overall Study STARTED	10	10	10	10	8
Overall Study COMPLETED	10	9	10	10	8
Overall Study NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Measure	2 mg ANDV, 3 Dose Regimen 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	2 mg ANDV, 4 Dose Regimen 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 3 Dose Regimen 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 4 Dose Regimen 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	Placebo 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner. Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
Overall Study Withdrawal by Subject	0	1	0	0	0

Baseline Characteristics

Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device

Baseline characteristics by cohort

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner. Andes virus DNA vaccine: A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.	Placebo n=8 Participants 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) or 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner. Placebo: Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System	Total n=48 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 6.8 • n=5 Participants	33.8 years STANDARD_DEVIATION 8.1 • n=7 Participants	34.9 years STANDARD_DEVIATION 8.9 • n=5 Participants	35.9 years STANDARD_DEVIATION 10.4 • n=4 Participants	30.6 years STANDARD_DEVIATION 8.8 • n=21 Participants	34.7 years STANDARD_DEVIATION 8.6 • n=10 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	33 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	15 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	46 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=10 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	37 Participants n=10 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Day 8, Day 36, Day 64, Day 176

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Laboratory parameters include alanine aminotransferase (ALT), total bilirubin, creatinine, blood urea nitrogen (BUN), hemoglobin, absolute neutrophil count (ANC), sodium, potassium, white blood cells (WBC), and platelet count.

Laboratory results were considered adverse events using the following thresholds: ALT 50 IU/L or greater; total bilirubin 1.30 mg/dL or greater; creatinine 0.81 mg/dL or greater (female) or 1.11 mg/dL or greater (male); BUN 24 mg/dL or greater; hemoglobin 11.6 g/dL or lower (female) or 13.2 g/dL or lower (male); ANC <1.8 K/mcL; sodium 135 mmol/L or lower (decrease) or 146 mmol/L or greater (increase); potassium 3.0 mmol/L or lower (decrease) or 5.2 mmol/L or greater (increase); WBC 4.4 K/mcL or lower (decrease) or 13.1 K/mcL or greater (increase 18 to <21 years) and 11.1 K/mcL or greater (increase 21 years or older); or platelets 134 K/mcL or below (decrease) or 467 K/mcL or greater (increase).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ALT : Day 36	0 participants	2 participants	0 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ALT : Day 64	0 participants	2 participants	0 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ALT : Day 176	2 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Creatinine : Day 8	0 participants	1 participants	2 participants	5 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events BUN : Day 176	1 participants	—	3 participants	3 participants	—
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Hemoglobin : Day 176	2 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ANC : Day 8	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ANC : Day 64	0 participants	2 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ANC : Day 176	0 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Sodium increase : Day 8	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC increase : Day 36	1 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Platelets increased : Day 8	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Total bilirubin : Day 8	0 participants	0 participants	0 participants	0 participants	1 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Total bilirubin : Day 36	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Total bilirubin : Day 64	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Total bilirubin : Day 176	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Creatinine : Day 36	1 participants	1 participants	2 participants	4 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Creatinine : Day 64	0 participants	0 participants	1 participants	4 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Creatinine : Day 176	1 participants	0 participants	3 participants	3 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events BUN : Day 8	—	1 participants	2 participants	4 participants	—
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events BUN : Day 36	—	1 participants	2 participants	4 participants	—
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events BUN : Day 64	—	—	1 participants	4 participants	—
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Hemoglobin : Day 8	0 participants	1 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Hemoglobin : Day 36	1 participants	1 participants	1 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Hemoglobin : Day 64	1 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events ANC : Day 36	0 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Sodium increase : Day 36	0 participants	0 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC decrease : Day 8	0 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC decrease : Day 36	0 participants	2 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC decrease : Day 64	0 participants	3 participants	1 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC decrease : Day 176	0 participants	2 participants	1 participants	1 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events WBC increase : Day 8	1 participants	0 participants	1 participants	0 participants	0 participants
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events Platelets increased : Day 64	0 participants	1 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 1 through Day 337

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

An adverse event was considered serious if it resulted in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 337

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

An adverse event is considered serious if it results in any of the following outcomes: death, a life-threatening adverse event (its occurrence places the participant at immediate risk of death), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Adverse events can be considered serious when they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 197

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 At least one unsolicited AE	6 Participants	8 Participants	9 Participants	8 Participants	5 Participants
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 No unsolicited AEs	4 Participants	2 Participants	1 Participants	2 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 197

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Unsolicited non-serious AEs were documented and reported from the time of first study vaccination through 28 days after the last study vaccination or after Day 169 if the fourth vaccination wasn't received.

An adverse event was considered related to the study product if there was a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 At least one related unsolicited AE	2 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197 None	8 Participants	8 Participants	8 Participants	7 Participants	6 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring >0mm), induration, induration measurement (measuring >0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring >0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Pain	2 participants	8 participants	7 participants	6 participants	1 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Tenderness	7 participants	9 participants	6 participants	7 participants	2 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Erythema (measurement)	7 participants	9 participants	8 participants	4 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Induration	4 participants	10 participants	7 participants	7 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Ecchymosis	2 participants	4 participants	3 participants	3 participants	2 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Ecchymosis (measurement)	2 participants	4 participants	4 participants	3 participants	2 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Erythema	7 participants	9 participants	8 participants	4 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Induration (measurement)	4 participants	10 participants	7 participants	7 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8 Skin Discoloration	2 participants	2 participants	2 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring >0mm), induration, induration measurement (measuring >0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring >0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Pain	0 participants	4 participants	7 participants	4 participants	1 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Tenderness	3 participants	9 participants	8 participants	7 participants	2 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Erythema (measurement)	7 participants	9 participants	8 participants	6 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Induration	4 participants	10 participants	6 participants	7 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Ecchymosis	1 participants	3 participants	5 participants	2 participants	0 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Ecchymosis (measurement)	1 participants	3 participants	6 participants	2 participants	0 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Erythema	7 participants	9 participants	8 participants	5 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Induration (measurement)	4 participants	10 participants	6 participants	7 participants	3 participants
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36 Skin discoloration	0 participants	2 participants	0 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: Day 57 through Day 64

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement (measuring >0mm), induration, induration measurement (measuring >0mm), skin discoloration, ecchymosis, and ecchymosis measurement (measuring >0mm). Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Erythema	7 Participants	10 Participants	6 Participants	6 Participants	2 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Induration	5 Participants	8 Participants	5 Participants	6 Participants	3 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Skin Discoloration	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Erythema (Measurement)	7 Participants	10 Participants	6 Participants	6 Participants	2 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Pain	2 Participants	5 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Tenderness	4 Participants	7 Participants	7 Participants	5 Participants	1 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Induration (Measurement)	5 Participants	8 Participants	5 Participants	6 Participants	3 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Ecchymosis	1 Participants	5 Participants	1 Participants	3 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64 Ecchymosis (Measurement)	1 Participants	5 Participants	1 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 169 through Day 176

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Local adverse events solicited on a memory aid provided to participants included pain, tenderness, erythema, erythema measurement, induration, induration measurement, skin discoloration, ecchymosis, and ecchymosis measurement. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Ecchymosis	3 Participants	3 Participants	2 Participants	3 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Ecchymosis (Measurement)	3 Participants	3 Participants	2 Participants	3 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Pain	2 Participants	8 Participants	2 Participants	4 Participants	1 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Tenderness	6 Participants	9 Participants	8 Participants	5 Participants	1 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Erythema	7 Participants	9 Participants	10 Participants	6 Participants	2 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Erythema (Measurement)	7 Participants	9 Participants	10 Participants	6 Participants	2 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Induration	7 Participants	8 Participants	7 Participants	7 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Induration (Measurement)	7 Participants	8 Participants	7 Participants	7 Participants	0 Participants
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176 Skin Discoloration	2 Participants	3 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the first vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Headache	3 participants	4 participants	4 participants	5 participants	2 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Nausea	0 participants	1 participants	1 participants	1 participants	1 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Diziness	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Feverishness	0 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Malaise	2 participants	2 participants	3 participants	1 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Fatigue	3 participants	3 participants	4 participants	2 participants	1 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Myalgia	0 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8 Fever	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the second vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Feverishness	0 participants	0 participants	1 participants	1 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Malaise	0 participants	1 participants	2 participants	2 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Fatigue	0 participants	5 participants	3 participants	2 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Myalgia	1 participants	1 participants	1 participants	0 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Headache	0 participants	1 participants	2 participants	3 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Nausea	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Dizziness	0 participants	0 participants	2 participants	0 participants	0 participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36 Fever	0 participants	0 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 57 through Day 64

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the third vaccination.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Feverishness	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Dizziness	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Fever	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Malaise	0 Participants	3 Participants	2 Participants	1 Participants	1 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Fatigue	1 Participants	5 Participants	2 Participants	2 Participants	1 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Myalgia	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Headache	2 Participants	4 Participants	2 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64 Nausea	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 169 through Day 176

Population: The Safety Analysis population includes all participants who received at least one dose of study vaccine.

Systemic adverse events solicited on a memory aid provided to participants included feverishness, malaise, fatigue, myalgia, headache, nausea, dizziness, and fever. Participants were considered to have experienced the AE if they reported an event of mild or greater severity on any of the 7 days following the fourth vaccination.

Systemic AEs were considered mild severity if they were noticeable but did not interfere with daily activity; events (other than headache) were considered moderate severity if they interfered with daily activity; events (other than headache) were considered severe severity if they caused significant interference and prevented daily activity. Headache events were considered moderate severity if they required any use of pain reliever or interfered with daily activity; headache events were severe if they prevented daily activity or required use of a prescription medication.

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Headache	3 Participants	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Feverishness	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Malaise	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Fatigue	3 Participants	4 Participants	1 Participants	1 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Myalgia	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Nausea	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Dizziness	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176 Fever	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1, Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).

Results lower than the limit of detection (<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers Day 197	32.9 titer Interval 11.8 to 91.8	68.5 titer Interval 14.5 to 324.2	50.4 titer Interval 17.6 to 143.9	217.7 titer Interval 71.7 to 660.9	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers Day 1	14.1 titer A confidence interval was not able to be computed for any arm at Day 1 due to a lack of variation in the data.	14.1 titer A confidence interval was not able to be computed for any arm at Day 1 due to a lack of variation in the data.	14.1 titer A confidence interval was not able to be computed for any arm at Day 1 due to a lack of variation in the data.	14.1 titer A confidence interval was not able to be computed for any arm at Day 1 due to a lack of variation in the data.	14.1 titer A confidence interval was not able to be computed for any arm at Day 1 due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers Day 57	14.1 titer Interval 11.4 to 27.7	24.6 titer Interval 13.1 to 46.3	37.3 titer Interval 13.9 to 99.7	24.6 titer Interval 10.5 to 57.2	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers Day 85	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.	45.9 titer Interval 14.5 to 145.3	28.2 titer Interval 13.1 to 60.8	34.8 titer Interval 13.5 to 89.4	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.

SECONDARY outcome

Timeframe: Day 1, Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The geometric mean titer was calculated for each study arm from the results available at Day 1 prior to the first study vaccination, 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).

Results lower than the limit of detection (<20) were reported and analyzed as 14.1 (which is 20/ sqrt(2)).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers Day 1	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.	14.1 titer Interval 12.9 to 17.6	14.1 titer Interval 11.0 to 26.8	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.	14.1 titer A confidence interval was not able to be computed due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers Day 57	22 titer Interval 10.1 to 48.0	35.6 titer Interval 15.8 to 80.4	200.1 titer Interval 30.5 to 1312.4	68.8 titer Interval 17.2 to 276.1	14.1 titer NA Explanation: A confidence interval was not able to be computed due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers Day 85	14.1 titer Interval 10.8 to 28.1	67.1 titer Interval 19.3 to 233.6	119.4 titer Interval 27.2 to 524.2	186.1 titer Interval 38.2 to 905.9	14.1 titer NA Explanation: A confidence interval was not able to be computed due to a lack of variation in the data.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers Day 197	112.5 titer Interval 16.0 to 791.8	230.5 titer Interval 70.8 to 750.8	234.8 titer Interval 50.0 to 1103.3	808.2 titer Interval 168.2 to 3882.4	14.1 titer NA Explanation: A confidence interval was not able to be computed due to a lack of variation in the data.

SECONDARY outcome

Timeframe: Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers Day 197	4 participants	4 participants	6 participants	8 participants	0 participants
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers Day 57	2 participants	4 participants	4 participants	2 participants	0 participants
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers Day 85	0 participants	4 participants	4 participants	4 participants	0 participants

SECONDARY outcome

Timeframe: Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. The number of participants with a titer greater than or equal to 20 was recorded for each study arm from the results available at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), 28 days following the fourth study vaccination (Day 197).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers Day 57	2 participants	5 participants	6 participants	5 participants	0 participants
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers Day 85	1 participants	5 participants	6 participants	7 participants	0 participants
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers Day 197	5 participants	9 participants	8 participants	8 participants	0 participants

SECONDARY outcome

Timeframe: Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% plaque reduction neutralization test (PRNT) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers Day 85	0 percentage of participants Interval 0.0 to 30.8	40 percentage of participants Interval 12.2 to 73.8	30 percentage of participants Interval 6.7 to 65.2	40 percentage of participants Interval 12.2 to 73.8	0 percentage of participants Interval 0.0 to 36.9
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers Day 57	11.1 percentage of participants Interval 0.3 to 48.2	30 percentage of participants Interval 6.7 to 65.2	40 percentage of participants Interval 12.2 to 73.8	20 percentage of participants Interval 2.5 to 55.6	0 percentage of participants Interval 0.0 to 41.0
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers Day 197	33.3 percentage of participants Interval 7.5 to 70.1	44.4 percentage of participants Interval 13.7 to 78.8	55.6 percentage of participants Interval 21.2 to 86.3	88.9 percentage of participants Interval 51.8 to 99.7	0 percentage of participants Interval 0.0 to 36.9

SECONDARY outcome

Timeframe: Day 57, Day 85, Day 197

Population: All participants in the intent-to-treat (ITT) population with valid results available at the given time point were included. Participants were included in the ITT population if they received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination for immunogenicity testing for which valid results (results are not missing and the laboratory did not deem the sample or results unfit for analysis) were reported.

Venous blood was collected to perform a 50% pseudovirion neutralization assay (PsVNA) which was conducted with Andes Virus as the antigen. A participant was considered to have seroconverted if their titer measured at least 40 if the baseline titer was less than 20, or if there was at least a 4-fold rise in titers from baseline if the baseline titer was greater than or equal to 20. The number of participants seroconverting was recorded for each study arm from the results at 28 days following the second study vaccination (and immediately prior to the third study vaccination; Day 57), 28 days following the third study vaccination (Day 85), and 28 days following the fourth study vaccination (Day 197).

Outcome measures

Measure	2 mg ANDV, 3 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 Participants 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 Participants 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers Day 57	22.2 percentage of participants Interval 2.8 to 60.0	30 percentage of participants Interval 6.7 to 65.2	60 percentage of participants Interval 26.2 to 87.8	50 percentage of participants Interval 18.7 to 81.3	0 percentage of participants Interval 0.0 to 41.0
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers Day 85	10 percentage of participants Interval 0.3 to 44.5	40 percentage of participants Interval 12.2 to 73.8	60 percentage of participants Interval 26.2 to 87.8	70 percentage of participants Interval 34.8 to 93.3	0 percentage of participants Interval 0.0 to 36.9
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers Day 197	55.6 percentage of participants Interval 21.2 to 86.3	77.8 percentage of participants Interval 40.0 to 97.2	88.9 percentage of participants Interval 51.8 to 99.7	88.9 percentage of participants Interval 51.8 to 99.7	0 percentage of participants Interval 0.0 to 52.2

Adverse Events

2 mg ANDV, 3 Dose Regimen

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

2 mg ANDV, 4 Dose Regimen

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

4 mg ANDV, 3 Dose Regimen

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

4 mg ANDV, 4 Dose Regimen

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	2 mg ANDV, 3 Dose Regimen n=10 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 participants at risk 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 participants at risk 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.

Other adverse events

Measure	2 mg ANDV, 3 Dose Regimen n=10 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	2 mg ANDV, 4 Dose Regimen n=10 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 3 Dose Regimen n=10 participants at risk 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	4 mg ANDV, 4 Dose Regimen n=10 participants at risk 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of ANDV DNA vaccine intramuscularly into the left and right deltoid on Days 1, 29, 57 and 169 in a double-blinded manner. Sentinel subjects received all doses in an open label manner.	Placebo n=8 participants at risk 2 mg (2 injections of 0.5 mL (1 mg/0.5 mL each)) or 4 mg (2 injections of 0.5 mL (2 mg/0.5 mL each)) of placebo intramuscularly into the left and right deltoid on Days 1, 29, 57, and 169 in a double-blinded manner.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Infections and infestations Gastroenteritis	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Infections and infestations Pharyngitis	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Infections and infestations Upper respiratory tract infection	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	50.0% 5/10 • Number of events 6 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	25.0% 2/8 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Respiratory, thoracic and mediastinal disorders Sinus congestion	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Gastrointestinal disorders Nausea	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 5 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	25.0% 2/8 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Fatigue	40.0% 4/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	70.0% 7/10 • Number of events 17 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	60.0% 6/10 • Number of events 10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	25.0% 2/8 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Feeling of body temperature change	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Injection site haemorrhage	30.0% 3/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	60.0% 6/10 • Number of events 15 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	60.0% 6/10 • Number of events 12 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 11 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	25.0% 2/8 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Malaise	40.0% 4/10 • Number of events 5 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	50.0% 5/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	50.0% 5/10 • Number of events 8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 6 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Vaccination site discolouration	30.0% 3/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Vaccination site erythema	90.0% 9/10 • Number of events 28 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	100.0% 10/10 • Number of events 37 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	100.0% 10/10 • Number of events 32 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	80.0% 8/10 • Number of events 22 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	75.0% 6/8 • Number of events 10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Vaccination site pain	80.0% 8/10 • Number of events 20 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	100.0% 10/10 • Number of events 34 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	80.0% 8/10 • Number of events 30 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	90.0% 9/10 • Number of events 26 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	75.0% 6/8 • Number of events 9 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
General disorders Vaccination site induration	90.0% 9/10 • Number of events 20 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	100.0% 10/10 • Number of events 36 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	90.0% 9/10 • Number of events 25 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	100.0% 10/10 • Number of events 27 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	62.5% 5/8 • Number of events 9 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations Blood bilirubin increased	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 5 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations Blood creatinine increased	10.0% 1/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 11 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	60.0% 6/10 • Number of events 25 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations Haemoglobin decreased	20.0% 2/10 • Number of events 11 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 9 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 5 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations Neutrophil count decreased	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 5 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations White blood cell count decreased	10.0% 1/10 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	50.0% 5/10 • Number of events 10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 7 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	12.5% 1/8 • Number of events 1 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Investigations White blood cell count increased	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Musculoskeletal and connective tissue disorders Myalgia	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	40.0% 4/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	10.0% 1/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Nervous system disorders Diziness	0.00% 0/10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 4 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	30.0% 3/10 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	20.0% 2/10 • Number of events 2 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	0.00% 0/8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.
Nervous system disorders Headache	50.0% 5/10 • Number of events 8 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	60.0% 6/10 • Number of events 11 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	70.0% 7/10 • Number of events 10 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	50.0% 5/10 • Number of events 14 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.	37.5% 3/8 • Number of events 3 • Non-serious AEs were collected through 28 days following the final vaccination, up to Day 197; SAEs were collected through Day 337.

Additional Information

Dr. Grant Paulsen

Cincinnati Children's Hospital

Phone: 513-636-4578

Email: Grant.Paulsen@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60