Hantavirus Pulmonary InfectionPhase 1NCT03682107
Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
A Phase 1 study testing Andes virus DNA vaccine in people with Hantavirus Pulmonary Infection and Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hantavirus Pulmonary Infection, Immunisation
- What is being tested?
- Andes virus DNA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2019to 23 Sep 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
- Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
- Pulse is 47 to 105 beats per minute (bpm), inclusive.
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- 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.
- Urine protein screen is negative or trace.
- Drug screen for opiates is negative.
- HgbA1C < 6.3% at screening.
- HIV - 1/2 antibody negative.
- HCV antibody negative.
- HBsAg negative.
- Women of childbearing potential*, must be using an effective method of contraception** from 30 days prior to the first study vaccination until 90 days after the last study vaccination.
- Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure (or with use of another birth control method if history of confirmation test not confirmed), AND are still menstruating or < 1 year since the last menses if perimenoapausal.
- For this study, we define an effective contraceptive method as one that results in a failure rate of less than 1% per year when it is used consistently and correctly. This includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
- Women of childbearing potential* must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
- See definition of women of childbearing potential above.
- Sexually active male participants whose partner is a woman of childbearing potential* and has not had a vasectomy must agree not to father a child until 90 days after the last vaccination*.
- See definition of women of childbearing potential above. **Performed > 1 year prior to screening
- Must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream or partner reports usage of occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Women agree to not donate eggs (ova, oocytes) and male subject agrees not to donate sperm from the start of screening onwards until at least 90 days after the last vaccination.
- Agree not to participate in another clinical trial during the study period.
- Agree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.
Who cannot join
- Women who are pregnant, planning to become pregnant or lactating*. *Includes breastfeeding or planning to breastfeed at any given time from the receipt of study vaccination through the 12-month trial period.
- Known allergy or history of anaphylaxis, severe local or other serious adverse reactions to vaccines or vaccine products*, or history of severe allergic reactions.
- This includes a known allergy to an aminoglycoside (e.g., gentamicin, tobramycin, neomycin, streptomycin).
- Received an experimental agent* within 3 months prior to study vaccination, or expects to receive an experimental agent** during the 12-month trial-reporting period.
- Including vaccine, drug, biologic, device, blood product, or medication.
- Other than from participation in this study.
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- Received any licensed live vaccine within 28 days prior to or after each study vaccination.
- Received a licensed inactivated vaccine within 14 days prior to or after each study vaccination*.
- Allowable exception for inactivated seasonal influenza vaccine received more than 7 days prior to or after a study vaccination.
- Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, unacceptably obscured due to a physical condition or permanent body art.
- Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. Subjects may re-screen after an acute illness is resolved
- Any confirmed or suspected immunosuppressive or immunodeficient condition* or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
- Including HIV infection
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of receipt of study vaccine*.
- For corticosteroids, this means prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Intranasal and topical steroids ARE allowed; daily inhaled steroids for treatment of asthma NOT allowed.
- History of receipt of a Hantavirus vaccine, including vaccines for Hantaan virus, Puumala virus, or combination of both.
- Exposed to ANDV* or plans to travel to an endemic area** from enrollment through 6 months post last vaccination.
- Residence in an ANDV endemic area in the last 3 years or > 2 consecutive weeks of travel to an ANDV endemic area in the last 3 years.
- ANDV endemic areas include Chile, Brazil and Argentina.
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding febrile seizures as a child.
- History of receiving immunoglobulin or other blood product within the 3 months before enrollment in this study.
- Current or past history of alcohol or drug abuse in the last 5 years.
- Subjects with autoimmune disorders, chronic inflammatory disorders or neurological disorders with a potential autoimmune correlation.
- Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
- Have received any antiviral within 3 days of study vaccination.
- A diagnosis of Type I or II diabetes.
- Current employee or staff paid entirely or partially by the contract for this trial, or staff who are supervised by the PI or Sub-Investigators.
- Any condition that would, in the opinion of the Site Investigator or appropriate sub-investigator, is a contraindication to study participation*.
- Including acute or chronic (persisting for at least 90 days) clinically significant medical disease or condition, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3039
About this study
Official title: A Phase I, Randomized, Placebo Controlled, Double-Blind, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection System in Normal Healthy Adults
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.
Read the 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.
- Conditions
- Hantavirus Pulmonary Infection, Immunisation
- Being tested
- Andes virus DNA vaccine, Placebo
- Keywords
- Andes Virus DNA, ANDV DNA, Hantavirus, Immunogenicity, PharmaJet Stratis, Pulmonary Syndrome, Safety, Vaccine
- Medical subject headings
- Hantavirus Pulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andes virus DNA vaccineBiological
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.
PlaceboOther
Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (2 mg ANDV - 3-dose regimen) | Experimental | 1 sentinel subject assigned to the 3-dose regimen will receive 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 Day 1 in an open label manner, and 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine on Days 29, 169, and matching placebo on Day 57 in double-blind manner.
11 subjects assigned to the 3-dose regimen will receive either 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, 169, and matching placebo on Day 57 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). Receives: Biological: Andes virus DNA vaccine; Other: Placebo |
| Arm 2 (2 mg ANDV - 4-dose regimen) | Experimental | 1 sentinel subject assigned to the 4-dose regimen will receive 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 Day 1 in an open label manner, and Days 29, 57 and 169 in double-blind manner.
11 subjects assigned to the 4-dose regimen will receive either 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 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). Receives: Biological: Andes virus DNA vaccine; Other: Placebo |
| Arm 3 (4 mg ANDV - 3-dose regimen) | Experimental | 1 sentinel subject assigned to the 3-dose regimen will receive 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 Day 1 in an open label manner, and 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine on Days 29, 169, and matching placebo on Day 57 in double-blind manner.
11 subjects assigned to the 3-dose regimen will receive either 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, and matching placebo on Day 57 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). Receives: Biological: Andes virus DNA vaccine; Other: Placebo |
| Arm 4 (4 mg ANDV - 4-dose regimen) | Experimental | 1 sentinel subject assigned to the 4-dose regimen will receive 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 Day 1 in an open label manner, and Days 29, 57 and 169 in double-blind manner.
11 subjects assigned to the 4-dose regimen will receive either 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 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). Receives: Biological: Andes virus DNA vaccine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events
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).
Measured: Day 8, Day 36, Day 64, Day 176
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337
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.
Measured: Day 1 through Day 337
Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337
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.
Measured: Day 1 through Day 337
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
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.
Measured: 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
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.
Measured: Day 1 through Day 197
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8
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.
Measured: Day 1 through Day 8
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36
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.
Measured: Day 29 through Day 36
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64
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.
Measured: Day 57 through Day 64
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176
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.
Measured: Day 169 through Day 176
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8
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.
Measured: Day 1 through Day 8
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36
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.
Measured: Day 29 through Day 36
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64
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.
Measured: Day 57 through Day 64
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176
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.
Measured: Day 169 through Day 176
Secondary outcomes (6)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers
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)).
Measured: Day 1, Day 57, Day 85, Day 197
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers
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)).
Measured: Day 1, Day 57, Day 85, Day 197
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers
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).
Measured: Day 57, Day 85, Day 197
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers
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).
Measured: Day 57, Day 85, Day 197
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers
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).
Measured: Day 57, Day 85, Day 197
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers
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).
Measured: Day 57, Day 85, Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start19 Feb 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hantavirus Pulmonary InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682107
- Sponsor's protocol ID
- 16-0119
- Other IDs
- HHSN272201300016I
- Status last verified
- 6 Apr 2021
- First submitted
- 20 Sep 2018
- Last updated
- 22 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Paulsen GC, Frenck R Jr, Tomashek KM, Alarcon RM, Hensel E, Lowe A, Brocato RL, Kwilas SA, Josleyn MD, Hooper JW. Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: A Randomized, Controlled Phase 1 Study. J Infect Dis. 2024 Jan 12;229(1):30-38. doi: 10.1093/infdis/jiad235.
PubMed 37380156
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo Controlled, Double-Blind, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection System in Normal Healthy Adults
- ClinicalTrials.gov ID
- NCT03682107
- Acronym / sponsor ID
- 16-0119
- Conditions
- Hantavirus Pulmonary Infection, Immunisation
- Keywords
- Andes Virus DNA, ANDV DNA, Hantavirus, Immunogenicity, PharmaJet Stratis, Pulmonary Syndrome, Safety, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (2 mg ANDV - 3-dose regimen) | Experimental | Biological: Andes virus DNA vaccine, Other: Placebo1 sentinel subject assigned to the 3-dose regimen will receive 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 Day 1 in an open label manner, and 2 mg (2 injections of 0.5 ml (1 mg/0.5 ml each)) of ANDV DNA vaccine on Days 29, 169, and matching placebo on Day 57 in double-blind manner. 11 subjects assigned to the 3-dose regimen will receive either 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, 169, and matching placebo on Day 57 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). |
| Arm 2 (2 mg ANDV - 4-dose regimen) | Experimental | Biological: Andes virus DNA vaccine, Other: Placebo1 sentinel subject assigned to the 4-dose regimen will receive 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 Day 1 in an open label manner, and Days 29, 57 and 169 in double-blind manner. 11 subjects assigned to the 4-dose regimen will receive either 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 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). |
| Arm 3 (4 mg ANDV - 3-dose regimen) | Experimental | Biological: Andes virus DNA vaccine, Other: Placebo1 sentinel subject assigned to the 3-dose regimen will receive 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 Day 1 in an open label manner, and 4 mg (2 injections of 0.5 ml (2 mg/0.5 ml each)) of ANDV DNA vaccine on Days 29, 169, and matching placebo on Day 57 in double-blind manner. 11 subjects assigned to the 3-dose regimen will receive either 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, and matching placebo on Day 57 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). |
| Arm 4 (4 mg ANDV - 4-dose regimen) | Experimental | Biological: Andes virus DNA vaccine, Other: Placebo1 sentinel subject assigned to the 4-dose regimen will receive 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 Day 1 in an open label manner, and Days 29, 57 and 169 in double-blind manner. 11 subjects assigned to the 4-dose regimen will receive either 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 (n=9) or matching placebo on Days 1, 29, 57, and 169 (n=2). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- 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.
- Are in good health*. *As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, ER or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this inclusion criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (apart from steroids as outlined in the Subject Exclusion Criteria), herbals, vitamins, and supplements are permitted.
- Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).
Key exclusion criteria (31 listed)
- Women who are pregnant, planning to become pregnant or lactating*. *Includes breastfeeding or planning to breastfeed at any given time from the receipt of study vaccination through the 12-month trial period.
- Known allergy or history of anaphylaxis, severe local or other serious adverse reactions to vaccines or vaccine products*, or history of severe allergic reactions.
- This includes a known allergy to an aminoglycoside (e.g., gentamicin, tobramycin, neomycin, streptomycin).
- Received an experimental agent* within 3 months prior to study vaccination, or expects to receive an experimental agent** during the 12-month trial-reporting period.
- Including vaccine, drug, biologic, device, blood product, or medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andes virus DNA vaccineA 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. | Biological | Arm 1 (2 mg ANDV - 3-dose regimen), Arm 2 (2 mg ANDV - 4-dose regimen), Arm 3 (4 mg ANDV - 3-dose regimen), Arm 4 (4 mg ANDV - 4-dose regimen) |
| PlaceboNormal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System | Other | Arm 1 (2 mg ANDV - 3-dose regimen), Arm 2 (2 mg ANDV - 4-dose regimen), Arm 3 (4 mg ANDV - 3-dose regimen), Arm 4 (4 mg ANDV - 4-dose regimen) |
Primary outcome
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events
Time frame: Day 8, Day 36, Day 64, Day 176
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).
Number of Participants Reporting Serious Adverse Events (SAEs) From Day 1 Through Day 337
Time frame: Day 1 through Day 337
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.
Number of Participants Reporting Vaccine-Related Serious Adverse Events (SAEs) From Day 1 Through Day 337
Time frame: Day 1 through Day 337
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.
Number of Participants Experiencing Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Time frame: Day 1 through Day 197
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.
Number of Participants Experiencing Vaccine-Related Unsolicited Non-Serious Adverse Events at Any Time From Day 1 to Day 197
Time frame: Day 1 through Day 197
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.
Number of Participants Reporting Solicited Local Adverse Events From Day 1 Through Day 8
Time frame: Day 1 through Day 8
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.
Number of Participants Reporting Solicited Local Adverse Events From Day 29 Through Day 36
Time frame: Day 29 through Day 36
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.
Number of Participants Reporting Solicited Local Adverse Events From Day 57 Through Day 64
Time frame: Day 57 through Day 64
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.
Number of Participants Reporting Solicited Local Adverse Events From Day 169 Through Day 176
Time frame: Day 169 through Day 176
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.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 1 Through Day 8
Time frame: Day 1 through Day 8
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.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 29 Through Day 36
Time frame: Day 29 through Day 36
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.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 57 Through Day 64
Time frame: Day 57 through Day 64
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.
Number of Participants Reporting Solicited Systemic Adverse Events From Day 169 Through Day 176
Time frame: Day 169 through Day 176
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.
6 secondary outcomes
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Plaque Reduction Neutralization Titers
Time frame: Day 1, Day 57, Day 85, Day 197
Geometric Mean Titers (GMTs) of Neutralizing Antibodies to ANDV Measured by Pseudovirion Neutralization Titers
Time frame: Day 1, Day 57, Day 85, Day 197
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Plaque Reduction Neutralization Titers
Time frame: Day 57, Day 85, Day 197
Number of Participants With ANDV Antibody Titers Greater Than or Equal to 20 as Measured by Pseudovirion Neutralization Titers
Time frame: Day 57, Day 85, Day 197
Percentage of Participants Achieving ANDV Antibody Seroconversion as Measured by Plaque Reduction Neutralization Titers
Time frame: Day 57, Day 85, Day 197
Percentage of Participants Achieving ANDV Antibody Seroconversion at Day 57 as Measured by Pseudovirion Neutralization Titers
Time frame: Day 57, Day 85, Day 197
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37380156Paulsen GC, Frenck R Jr, Tomashek KM, Alarcon RM, Hensel E, Lowe A, Brocato RL, Kwilas SA, Josleyn MD, Hooper JW. Safety and Immunogenicity of an Andes Virus DNA Vaccine by Needle-Free Injection: A Randomized, Controlled Phase 1 Study. J Infect Dis. 2024 Jan 12;229(1):30-38. doi: 10.1093/infdis/jiad235.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Andes virus DNA vaccine in people with Hantavirus Pulmonary Infection and Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Clinical Safety Laboratory Adverse Events (time frame: Day 8, Day 36, Day 64, Day 176). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.