Dengue Vaccine for Dengue Fever
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine for dengue fever, a mosquito-borne disease common in tropical areas. The goal is to determine the vaccine's safety and its effects on the immune system, particularly in individuals with or without prior dengue exposure. The trial seeks healthy adults aged 18 to 59 who can attend several clinic visits over seven months. Participants should not have received any dengue vaccine before and should avoid traveling to areas where dengue is common during the study period. As a Phase 1 trial, this research aims to understand how the new vaccine works in people, offering participants the unique opportunity to be among the first to receive this treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive medications, cytotoxic medication, or immunomodulating therapy, you may not be eligible to participate. It's best to discuss your specific medications with the trial staff.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that the investigational dengue vaccine, rDENdelta30/31-7164, uses a live but weakened form of the virus. This method helps the immune system learn to fight the virus without causing the disease. Previous studies on similar vaccines have generally shown they are well-tolerated by participants, with most side effects being mild and temporary, such as soreness at the injection site or a mild fever.
It is important to note that this vaccine is still in the early stages of testing. While initial safety results are promising, data remains limited. Participants should understand that a Phase 1 trial primarily examines safety and dosage. Although earlier studies of similar vaccines reported no serious side effects, the complete safety profile of this specific vaccine is still under investigation.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the dengue vaccine candidate, rDENdelta30/31-7164, because it offers a fresh approach to preventing dengue fever, a mosquito-borne illness that currently lacks a widely effective vaccine. Unlike current options like Dengvaxia, which is only recommended for those previously infected with dengue, this investigational vaccine is designed to be effective for a broader range of individuals, including those who are flavivirus naive. It targets different antibody profiles, potentially offering protection even to those with limited or no prior exposure to dengue virus serotypes. By engaging the immune system in a new way, it holds promise for more comprehensive and universal dengue prevention.
What evidence suggests that this vaccine might be an effective treatment for dengue fever?
Research shows that the rDENdelta30/31-7164 vaccine aims to protect against dengue by using a weakened form of the virus. Specific changes in the virus's genetic material help activate the immune system without causing illness. Early results suggest this method could create a strong immune response, potentially making it effective against dengue. In this trial, participants will be divided into different treatment arms based on their dengue antibody profiles to assess the vaccine's effectiveness and safety. However, as the vaccine remains in early testing stages, more information is needed to confirm its effectiveness and safety in people.12346
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?
Healthy adults aged 18 to 59 can join this trial. They must not have had certain vaccines recently, avoid travel to dengue areas, and use effective contraception if they can get pregnant. Excluded are those with severe allergies, uncontrolled health conditions like asthma or diabetes, drug abuse issues, or a history of serious vaccine reactions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the DENV3 monovalent vaccine and are monitored for safety and immune response
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Extension
Participants may opt to return for a last visit after 12 months
What Are the Treatments Tested in This Trial?
Interventions
- rDENdelta30/31-7164
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor