200 Participants NeededMy employer runs this trial

rDEN2delta30-7169 for Dengue Fever

CD
Overseen ByCamila D Odio, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about dengue fever, a mosquito-borne virus that can cause severe symptoms like shock and internal bleeding. Researchers will use a weakened version of the dengue virus, called rDEN2delta30-7169, to observe how healthy individuals' bodies react. Participants should be in good health and may or may not have been exposed to dengue previously. The study involves multiple visits over six months, during which participants will undergo blood tests and other exams to monitor their response. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take potent anticoagulants like warfarin during the first 28 days. If you're on other medications, it's best to discuss with the study staff.

Is there any evidence suggesting that rDEN2delta30-7169 is likely to be safe for humans?

Studies have shown that the rDEN2delta30-7169 treatment, a weakened form of the dengue virus, is undergoing safety testing. Research indicates that this modified virus is designed to be less harmful than the natural virus. The study primarily aims to assess its safety and how individuals, especially those with varying histories of dengue virus exposure, respond to it.

Although specific data on rDEN2delta30-7169's safety in humans remains limited, the study is in its early stages. Researchers closely monitor the treatment's safety. They carefully select participants to observe any unintended reactions, aiming to keep symptoms mild. While no clear evidence of serious safety issues has emerged, ongoing studies will further clarify its safety profile.12345

Why are researchers excited about this trial?

Unlike the standard of care for dengue fever, which often includes supportive treatments like fluids and pain relievers, rDEN2delta30-7169 is a vaccine candidate specifically targeting the dengue virus. Researchers are excited about this treatment because it introduces a modified live attenuated virus designed to provoke a strong immune response without causing disease. This vaccine is tailored for different groups based on their exposure to flaviviruses, potentially offering a more personalized and effective approach to preventing dengue infections.

What evidence suggests that this trial's treatment could be effective for dengue fever?

Research has shown that rDEN2delta30-7169 is being explored as a potential treatment for dengue by using a weakened form of the virus. This method aims to safely activate the body's immune system to combat the virus. Previous studies demonstrated that a weakened virus can help the immune system learn to recognize and fight the stronger version of the virus. Although direct evidence of its effectiveness against dengue is not yet available, this strategy resembles vaccines that have succeeded in treating other diseases. Early signs suggest it could aid in understanding and managing dengue infections. Participants in this trial will be divided into groups based on their previous exposure to flaviviruses, with arms labeled as Naive, Heterotypic, and Homotypic, to assess the treatment's effectiveness across different immune backgrounds.678910

Who Is on the Research Team?

CD

Camila D Odio, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

This trial is for healthy adults ages 18 to 50, whether or not they've had dengue before. Participants should be generally healthy and willing to attend multiple study visits over six months.

Inclusion Criteria

I am in good overall health based on recent exams and lab tests.
Willing to allow storage of samples and data for future research
Willing to forgo receipt of any vaccine in the 28 days preceding the challenge strain through the 28 days following administration of the challenge strain
See 14 more

Exclusion Criteria

Baseline absolute neutrophil count (ANC) <=750 cells/microL
I need to take strong blood thinners during the first month of the study.
Baseline ALT >=1.25 x upper limit of normal
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive an injection of the dengue virus and are monitored for safety and immune response

4 weeks
8 visits (in-person) in the first month

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood draws and optional procedures

6 months
3 visits (in-person) after the first month

Optional Procedures

Participants may undergo lymph node aspirations and bone marrow biopsies

Long-term Follow-up

Participants may have an additional visit about a year after for a blood draw

What Are the Treatments Tested in This Trial?

Interventions

  • rDEN2delta30-7169

Trial Overview

Researchers are injecting a weakened form of the dengue virus (rDEN2delta30-7169) into volunteers to safely study how the body reacts. The study involves regular blood tests, check-ups, and optional tissue samples over several months.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: NaiveExperimental Treatment1 Intervention
Group II: HomotypicExperimental Treatment1 Intervention
Group III: HeterotypicExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

Phase 1 Challenge Study Using rDEN2delta30-7169 to ...

Study Description: This is a phase 1 challenge trial where healthy adults with no flavivirus antibodies (naive), dengue virus serotype 2 (DENV2)- ...

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Our study showed that a 2-dose schedule of TAK-003 yielded a vaccine effectiveness of 73.1% (95% CI 69.1–76.6) against symptomatic dengue and ...

Protocol Details

Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection. This study ...

Evaluating the Safety and Effectiveness of a Dengue Virus ...

The purpose of this study is to evaluate the protective effectiveness of a dengue virus vaccine in healthy adults.

Cecil.md Clinical Trial Safety, Virological and Immunological ...

2 rDEN2delta30-7169. the vaccine showed enhanced hospitalization in recipients who were dengue-naà ̄ve before vaccination. can influence clinical outcomes and ...

Study Details | NCT05476757 | Safety, Virological and ...

Although this vaccine can induce neutralizing antibodies against all four DENV serotypes, the vaccine showed enhanced hospitalization in recipients who were ...

Vaccine Safety & Efficacy Data | Dengue

Dengvaxia is safe when used. It has an efficacy rate of about 80% against disease, hospitalization, and severe disease. Dengvaxia has an ...

Phase 1 Challenge Study Using rDEN2delta30-7169 to ...

Primary Objective: Evaluate the safety, viral RNAemia, and immunogenicity of rDEN2delta30-7169 in those with distinct DENV infection histories.

::: TCTR : Thai Clinical Trials Registry :::

This project is proposed to challenge the live attenuated dengue virus serotype 2, rDEN2delta30-7169, in 5 flavivirus naive participants recruited from Bangkok, ...

Dengue vaccine effectiveness and safety: a systematic ... - PMC

Safety profiles varied: TAK-003 and CYD-TDV reduced serious events, whereas TV005 was associated with heightened reactogenicity.