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Virus Therapy
Live Virus Human Challenge for Dengue Fever
Phase 1
Waitlist Available
Led By Stephen J Thomas, MD
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post reinfection, cohorts 3 and 4
Awards & highlights
Study Summary
This trial will investigate the body's response to two dengue infections over time. Participants will receive inoculations and be monitored in-person and via phone for up to 6 months. Saliva and blood will be collected.
Who is the study for?
Adults aged 18-55 who can commit to the study period, understand and consent to participate, agree to use contraception, and are not pregnant or planning pregnancy. Excluded are those with autoimmune diseases (except controlled Hashimoto's), history of GBS, recent travel to dengue areas, drug abuse, certain immunodeficiencies or treatments affecting immunity, significant mental health issues, heavy menstrual bleeding or known allergies related to the trial.Check my eligibility
What is being tested?
The trial is testing live virus human challenges with Dengue virus types 1 and 3 in a controlled setting. Participants will receive an inoculation followed by regular clinic visits for blood and saliva collection over several months. The goal is to better understand how the body responds when infected twice with Dengue.See study design
What are the potential side effects?
Potential side effects from the Dengue virus challenge may include typical symptoms of Dengue fever such as high fever, severe headache, pain behind the eyes, joint and muscle pain, fatigue, nausea/vomiting; some individuals might experience more serious complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post reinfection, cohorts 3 and 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post reinfection, cohorts 3 and 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Abnormal Laboratory Measurements
Duration of Solicited Injection Site Symptoms
Duration of Solicited Systemic Symptoms
+10 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4 Returning DENV3Experimental Treatment1 Intervention
Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), single dose (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1.
Group II: Cohort 3 Returning DENV1Experimental Treatment1 Intervention
Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), single dose (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1.
Group III: Cohort 2 Naive DENV3Experimental Treatment1 Intervention
Dengue-3-Virus-Live-Virus-Human-Challenge (DENV-3-LVHC), two doses (0.5 mL of 1.4 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181.
Group IV: Cohort 1 Naive DENV1Experimental Treatment1 Intervention
Dengue-1-Virus-Live-Virus-Human-Challenge (DENV-1-LVHC), two doses (0.5 mL of 6.5 x 10^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously on day 1 and day 181.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)
2020
Completed Phase 1
~10
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,755 Total Patients Enrolled
4 Trials studying Dengue Fever
320 Patients Enrolled for Dengue Fever
State University of New York - Upstate Medical UniversityLead Sponsor
172 Previous Clinical Trials
27,323 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
285 Previous Clinical Trials
245,150 Total Patients Enrolled
6 Trials studying Dengue Fever
903 Patients Enrolled for Dengue Fever
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like diabetes, stomach ulcers, lung or heart disease.I am not pregnant or breastfeeding.I am infected with HIV-1, hepatitis C, or hepatitis B.I am currently taking specific medications.I have been diagnosed with Bipolar Disorder or Schizophrenia and was recently hospitalized for it.I am between 18 and 55 years old.I suffer from chronic migraines.I have not donated blood or received blood products recently.I am against receiving blood products or transfusions due to my beliefs.I don't have any health issues that could make the trial unsafe for me.I have recently been vaccinated or have a vaccination scheduled.I do not have any autoimmune diseases or Guillain-Barré syndrome.I have a weakened immune system or am on immune-modifying drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 Naive DENV1
- Group 2: Cohort 3 Returning DENV1
- Group 3: Cohort 2 Naive DENV3
- Group 4: Cohort 4 Returning DENV3
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 middle-aged individuals encouraged to apply for this clinical research?
"Qualified participants for this medical trial must be of age 18 or higher and below 55 years old."
Answered by AI
What health hazards are associated with Cohort 1 Naive DENV1?
"The safety of Cohort 1 Naive DENV1 is expected to be low, awarding it a score of 1. This rating was applied due to the limited clinical evidence backing its effectiveness and safety during Phase 1 trials."
Answered by AI
Does this research endeavor have any vacancies for participants?
"According to clinicaltrials.gov, this particular medical trial is not actively recruiting participants at the current moment in time. Initially posted on August 1st 2023 and last updated on July 28th 2023, there are 25 other studies that are presently open for enrollment."
Answered by AI
How might I enter into this experiment?
"The requirements for participants of this trial include a diagnosis of dengue fever and being between 18 to 55 years old. A maximum of 20 candidates will be admitted into the study."
Answered by AI
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