Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
Condition: Hantavirus Pulmonary Infection; Immunisation
MeSH terms: Hantavirus Pulmonary Syndrome; Hantavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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. The secondary objective of this study is to assess the immunogenicity of the ANDV DNA
      vaccine by dosage cohort and treatment arm.
    

Intervention name(s): Andes virus DNA vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 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 or 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.; Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Andes Virus DNA; ANDV DNA; Hantavirus; Immunogenicity; PharmaJet Stratis; Pulmonary Syndrome; Safety; Vaccine