rDEN2delta30-7169 for Dengue Fever
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an injection of the dengue virus and are monitored for safety and immune response
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood draws and optional procedures
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
Those with no exposures to flaviviruses
Those with a DENV2-dominant serotype.
Those with their highest titer to a non-DENV2.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
1.
ctv.veeva.com
ctv.veeva.com/study/phase-1-challenge-study-using-rden2delta30-7169-to-evaluate-host-pathogen-interactions-in-primary-hPhase 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)- ...
2.
infectioncontroltoday.com
infectioncontroltoday.com/view/how-real-world-data-is-shaping-future-dengue-vaccinationHow Real-World Data Is Shaping the Future of Dengue ...
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 ...
3.
clinicalstudies.info.nih.gov
clinicalstudies.info.nih.gov/protocoldetails.aspx?id=002606-I&&query=VirusProtocol 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.
5.
veterans.networkofcare.org
veterans.networkofcare.org/cecil-md/CommunityResources/ClinicalTrials/Detail/NCT05476757?keyword=%22DENGUE%22Cecil.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.
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