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Dengue Virus Challenge for Dengue Fever
Phase 1
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
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 approximately 6 months post virus inoculation
Awards & highlights
Study Summary
This trial is testing different doses of an experimental dengue virus to see if it causes symptoms or viremia (circulating virus in the blood). The goal is to use this information to create a dengue challenge that can be used to test vaccines.
Who is the study for?
Healthy adults aged 18-50, who are not pregnant or breastfeeding and have no history of dengue or similar viral infections. Participants must understand the study and follow its requirements. Women able to bear children must use contraception before, during, and after the trial.Check my eligibility
What is being tested?
The trial is testing different doses of an experimental weakened dengue virus to see if it causes symptoms or viremia when given intentionally (a 'challenge'). This helps determine safe dosages for future vaccine effectiveness trials.See study design
What are the potential side effects?
Potential side effects may include typical symptoms associated with mild dengue fever such as headache, fever, muscle pain, joint pain, rash, nausea or vomiting. Since this is a challenge study with a live virus at controlled doses, close monitoring will be in place.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Abnormal Laboratory Measurements
Number of Participants with Dengue-Related Adverse Events
Number of Participants with Fever
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Medium Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)Experimental Treatment1 Intervention
0.95 x 10^3 Plaque Forming Units
Group II: Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)Experimental Treatment1 Intervention
0.95 x 10^2 Plaque Forming Units
Group III: High Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)Experimental Treatment1 Intervention
0.95 x 10^4 Plaque Forming Units
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose
2022
Completed Phase 1
~30
Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Medium Dose
2022
Completed Phase 1
~30
Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - High Dose
2022
Completed Phase 1
~30
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,627 Total Patients Enrolled
Medical Technology Enterprise Consortium (MTEC)UNKNOWN
2 Previous Clinical Trials
48 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction or allergy to any part of the study drug or any procedure related to the study.You have significant birth defects or long-term health problems.You have a history of neurological disorders or seizures.You have been drinking alcohol excessively or using drugs heavily in the recent past.You are currently taking medications like blood thinners, aspirin, or certain pain relievers called NSAIDs on a regular basis.You have had dengue or other similar viral infections in the past, including yellow fever, tick-borne-encephalitis virus (TBEV), or Japanese encephalitis.You have traveled to or plan to travel to an area where dengue fever is common within the past 4 weeks.You have a history of bipolar disorder, schizophrenia, recent hospitalization for mental health issues, or any other psychiatric condition that would make it difficult for you to take part in the study.You cannot have used any experimental or unapproved drugs or vaccines within 30 days before or during the study.You have an autoimmune disease or a history of having one.You have religious or personal beliefs that prevent you from receiving blood products, transfusions, or serum albumin.
Research Study Groups:
This trial has the following groups:- Group 1: Medium Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)
- Group 2: High Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)
- Group 3: Low Dose Dengue 4 Live Virus Human Challenge (DENV-4-LVHC)
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 there spots still available for prospective participants of this study?
"Clinicaltrials.gov indicates that this study, which was first published on February 28th 2022, is currently recruiting participants. The trial has been recently updated as of March 1st 2021."
Answered by AI
What risk factors should be considered when assessing the safety of exposure to a low dose of DENV-4-LVHC?
"The safety of Dengue 4 Live Virus Human Challenge (DENV-4-LVHC) - Low Dose is rated at 1 on our Power scale, as this trial is only in its first phase and there exists limited data regarding efficacy and safety."
Answered by AI
What is the current cap on participants in this clinical research endeavor?
"Affirmative. The clinicaltrials.gov page confirms that the trial, which was initially listed on February 28th 2022, is currently looking for participants. A total of 30 subjects are being accepted at 1 medical centre."
Answered by AI
Does the eligibility criteria for this clinical trial include those aged 50 and over?
"Qualified candidates for this medical trial must be aged between 18 and 50. Additionally, the research team has developed additional studies focused on individuals younger than 18 as well as those over 65 years old."
Answered by AI
Who is eligible to participate in this clinical research?
"To qualify for the trial, patients must demonstrate a positive diagnosis of dengue and must be between 18-50 years old. The study is looking to enrol roughly 30 individuals."
Answered by AI
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