What is the mechanism of action of this treatment?

The most common treatments for Dengue Fever focus on supportive care, as there are no specific antiviral therapies approved for the disease. However, experimental approaches like the weakened dengue virus challenge aim to induce a controlled infection to study the immune response and ensure safety. This method helps researchers understand how the immune system reacts to the virus, which is crucial for developing effective vaccines. For Dengue Fever patients, this research is vital as it can lead to the creation of vaccines that provide immunity, reducing the incidence and severity of the disease.

What side effects are associated with this type of intervention?

Common treatments for Dengue Fever primarily involve supportive care, including hydration, pain relievers, and fever reducers. Known side effects of these treatments are generally mild and may include gastrointestinal discomfort and allergic reactions. In rare cases, more severe reactions such as liver damage can occur, particularly with excessive use of medications like acetaminophen.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Dengue Fever mentioned in the provided context. The research study described involves a weakened form of an experimental dengue virus challenge to test immune response and safety, which is a method used to develop and test vaccines. This approach is similar to other viral challenge models used to study vaccine efficacy and safety, but no specific drugs or treatments have been approved by the FDA for Dengue Fever based on this method.

What other types of research exist?

Promising novel alternatives to the Weakened Dengue Virus Challenge for Dengue Fever patients include the development of new vaccine strategies, such as mRNA vaccines, which have shown success in other viral diseases like COVID-19. Additionally, advancements in monoclonal antibody therapies and nucleoside/nucleotide analogs are being explored for their potential efficacy in treating dengue fever. These approaches aim to enhance immune response and provide targeted treatment options without the need for controlled infection models.

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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

No Placebo-Only Group

Summary

This trial uses a less harmful version of the dengue virus to see how volunteers react. The goal is to find out how safe it is and determine the best dose for future vaccine testing. Researchers will monitor participants closely for any symptoms or presence of the virus in their blood.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Abnormal Laboratory Measurements

Number of Participants with Dengue-Related Adverse Events

Number of Participants with Fever

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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) - High Dose

2022

Completed Phase 1

~30

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Dengue Fever focus on supportive care, as there are no specific antiviral therapies approved for the disease. However, experimental approaches like the weakened dengue virus challenge aim to induce a controlled infection to study the immune response and ensure safety. This method helps researchers understand how the immune system reacts to the virus, which is crucial for developing effective vaccines. For Dengue Fever patients, this research is vital as it can lead to the creation of vaccines that provide immunity, reducing the incidence and severity of the disease.