CompletedPhase 1

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

United States48 participantsStarted 2019-02-19

Plain-language 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.

Who can participate

Age range18 Years – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent before initiation of any study procedures.
✓. Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
✓. Males or non-pregnant females ages 18-49, inclusive.

Exclusion criteria

✕. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
✕. Pulse is 47 to 105 beats per minute (bpm), inclusive.
✕. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
✕. Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
✕. Have acceptable screening laboratories\* within 28 days prior to enrollment. \*Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once.
✕0. Urine protein screen is negative or trace.

What they're measuring

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

Trial details

NCT IDNCT03682107

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-09-23

Results submitted2021-09-09

View on ClinicalTrials.gov More Hantavirus Pulmonary Infection trials

Plain-language summary

Who can participate

Age range18 Years – 49 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent before initiation of any study procedures.
✓. Are able to understand and comply with planned study procedures and be available for all study visits/phone calls.
✓. Males or non-pregnant females ages 18-49, inclusive.

Exclusion criteria

✕. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
✕. Pulse is 47 to 105 beats per minute (bpm), inclusive.
✕. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
✕. Diastolic blood pressure (BP) is 55 to 95 mm Hg, inclusive.
✕. Have acceptable screening laboratories\* within 28 days prior to enrollment. \*Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once.
✕0. Urine protein screen is negative or trace.

What they're measuring

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