This is a Phase 1, randomized, placebo controlled, double-blind, dose escalation trial of 48 males and non-pregnant females, 18-49 years old, inclusive, who are in good health and meet all eligibility criteria. This trial is designed to assess the safety, reactogenicity and immunogenicity of an Andes Virus (ANDV) DNA vaccine for the prevention of Hantavirus Pulmonary Syndrome (HPS). ANDV DNA vaccine or placebo will be administered using the PharmaJet Stratis(R) Needle-Free Injection System. The study duration is 23 months while the subject participation duration is 12 months. Subjects assigned to the 3 dose regimen will receive ANDV DNA vaccine on Days 1, 29 and 169, and placebo on Day 57. Subjects assigned to the 4 dose regimen will receive ANDV DNA on Days 1, 29, 57 and 169. Two doses (2 or 4 mg) of ANDV DNA vaccine will be evaluated. The primary objective of this study is to assess the safety and reactogenicity of the ANDV DNA vaccine by dosage cohort and treatment arm when administered using the PharmaJet Stratis(R) Needle-Free Injection system in normal, healthy adults.
Age range
18 Years – 49 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events
Timeframe: Day 8, Day 36, Day 64, Day 176
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337
Timeframe: Day 1 through Day 337
Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337
Timeframe: Day 1 through Day 337
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Timeframe: Day 1 through Day 197
Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Timeframe: Day 1 through Day 197
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8
Timeframe: Day 1 through Day 8
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36
Timeframe: Day 29 through Day 36
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64
Timeframe: Day 57 through Day 64
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176
Timeframe: Day 169 through Day 176
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8
Timeframe: Day 1 through Day 8
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36
Timeframe: Day 29 through Day 36
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64
Timeframe: Day 57 through Day 64
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176
Timeframe: Day 169 through Day 176