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Virus Therapy
Hantaan/Puumala Vaccines for Hemorrhagic Fever with Renal Syndrome
Phase 2
Waitlist Available
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at the time of screening
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 197 (+/- 2) days
Awards & highlights
Study Summary
This trial is comparing data from earlier studies to see if a lower dose of a Hantaan virus vaccine is still effective.
Who is the study for?
Adults aged 18-49 with no significant health issues, not pregnant or nursing, and able to pass a background check can join. They must score well on a study quiz, agree to use contraception, avoid other trials and blood donation during the study. Excluded are those with recent drug/vaccine use, certain diseases, substance abuse or plans for surgery.Check my eligibility
What is being tested?
The trial is testing whether lower doses of Hantaan and Puumala DNA vaccines retain their effectiveness in preventing Hemorrhagic Fever with Renal Syndrome. Participants will be divided into four groups to compare immunogenicity data from earlier phases.See study design
What are the potential side effects?
While specific side effects aren't listed here, DNA vaccines like these could potentially cause injection site reactions (like pain or swelling), mild fever, fatigue or muscle pains based on common vaccine responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are a man or a woman who is not pregnant or breastfeeding, and you are between 18 and 49 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 197 (+/- 2) days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~197 (+/- 2) days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of subjects in Group 1 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
The proportion of subjects in Group 3 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers.
Secondary outcome measures
The proportion of subjects in Group 2 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
The proportion of subjects in Group 4 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
Trial Design
4Treatment groups
Active Control
Group I: Group 1 - Full Dose HataanActive Control1 Intervention
Group 1 will be vaccinated with the "Full Dose" of HTNV DNA vaccine, 2 mg of pWRG/HTN-M(co) with 0.5 mg/each deltoid.
Group II: Group 2 - Half Dose HataanActive Control1 Intervention
Group 2 will be vaccinated with the "Half Dose" of HTNV DNA vaccine, 1 mg of pWRG/HTN-M(co) with 1.0 mg/each deltoid.
Group III: Group 3 - Full Dose PuumalaActive Control1 Intervention
Group 3 will be vaccinated with the "Full Dose" of PUUV DNA vaccine, 2 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid.
Group IV: Group 4 - Half Dose PuumalaActive Control1 Intervention
Group 4 will be vaccinated with the "Half Dose" of PUUV DNA vaccine, 1 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid.
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Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
285 Previous Clinical Trials
245,027 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant ongoing health issue with your blood, lungs, heart, liver, or kidneys, as determined by the doctor's examination and tests.You have been diagnosed with hepatitis B or C.You have been diagnosed with Type I or Type II diabetes.You currently have a problem with alcohol or drug abuse.You have been vaccinated for hantavirus in the past.You have a condition that weakens your immune system, or you have had cancer treatment within the past 3 years.Your recent lab test results are normal.You are a man or a woman who is not pregnant or breastfeeding, and you are between 18 and 49 years old.You have been diagnosed with schizophrenia, bipolar disease, or another psychiatric condition that could affect your ability to follow the study's requirements or be evaluated for safety.You have been in the hospital for a mental illness or have tried to harm yourself or others in the past 10 years.You have tested negative for HIV using a specific type of test.You do not have hepatitis B or hepatitis C.You have a long-lasting or ongoing neurological condition, such as seizures or epilepsy, except for a single fever-related seizure as a child or occasional non-migraine headaches.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 - Full Dose Hataan
- Group 2: Group 2 - Half Dose Hataan
- Group 3: Group 3 - Full Dose Puumala
- Group 4: Group 4 - Half Dose Puumala
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals outside of the 35+ age bracket being included in this research?
"The age limit for this particular trial is 49 years old. All participants must also be at least 18 years old."
Answered by AI
What are the risks associated with taking the maximum dosage of Group 1 - Full Dose Hataan?
"The Full Dose Hataan medication from Group 1 was given a safety score of 2. In clinical trials, Phase 2 drugs have not been shown to be effective yet, but there is some data supporting that they are safe."
Answered by AI
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