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New treatment option for Healthy Volunteers
Official title Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
ClinicalTrials.gov ID: NCT07706686
What this study is testing
What is rDEN2delta30-7169?
rDEN2delta30-7169 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Dengue is a viral disease spread by mosquitoes. Most people bitten by mosquitoes carrying dengue viruses do not get sick, but severe cases can cause shock, internal bleeding, and death.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18 to 50 years.
- In good general health as evidenced by medical history, physical examination, and laboratory screening results
- 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...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy.
- Lactation during the first 28 days of the study.
- Baseline absolute neutrophil count (ANC) \<=750 cells/microL.
- Baseline creatinine \>=1.5 mg/dL.
- Baseline ALT \>=1.25 x upper limit of normal.
See the full eligibility criteria
- To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18 to 50 years.
- In good general health as evidenced by medical history, physical examination, and laboratory screening results
- 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. For participants opting for LN FNA or bone marrow sampling on...
- For individuals who can become pregnant: use of at least one method of effective contraception (see below) from at least 28 days prior to challenge through 60 days after challenge.
- Able to provide informed consent.
- Willing to adhere to lifestyle considerations for the duration of the study.
- Willing to avoid travel to a dengue-endemic area as defined by the CDC from 1 month before administration of challenge through day 28. For participants opting for LN FNA or bone marrow sampling on day 57, they must be...
- Serologic evidence of previous dengue virus infection consistent with our serology criteria. a. For the flavivirus-naive group, they must have no history of flavivirus vaccination or medical illness concerning for a...
- Agree to avoid participation in other clinical studies requiring investigational interventions through day 180.
- Agree to avoid blood and plasma donation outside this study through day 57. Contraceptive requirements: Participants who can become pregnant must agree to use at least one method of effective contraception as outlined...
- Intrauterine device or equivalent.
- Hormonal contraceptive (e.g., consistent, timely, and continuous use of contraceptive pill, patch, ring, implant, or injection that has reached full how well it works prior to challenge).
- Condom, diaphragm, or cervical cap plus spermicide.
- A stable, long-term monogamous relationship with a partner who does not pose any potential pregnancy risk, e.g., has undergone a vasectomy at least 6 months prior to administration of challenge strain or is of the same...
- A hysterectomy and/or a bilateral tubal ligation, bilateral oophorectomy, or post-menopausal status defined as age \>=45 years and at least 1 year since last menstrual period. Participants who become pregnant after...
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy.
- Lactation during the first 28 days of the study.
- Baseline absolute neutrophil count (ANC) \<=750 cells/microL.
- Baseline creatinine \>=1.5 mg/dL.
- Baseline ALT \>=1.25 x upper limit of normal.
- Requiring a potent anticoagulator like a direct acting oral agent or warfarin during the first 28 days of the study.
- History of or positive test result for HIV, hepatitis B, or hepatitis C.
- History of a tetravalent, chimeric, or subunit dengue vaccine.
- Has any of the following:
- More than 10 days of systemic immunosuppressive medications (\>=10 mg prednisone dose or its equivalent) or cytotoxic medication within the 30 days prior to administration of challenge strain or immunomodulating therapy...
- Received blood products, including immunoglobulin products, within 120 days prior to administration of challenge strain.
- History of serious reactions to vaccines.
- Hereditary, acquired, or idiopathic forms of angioedema.
- Idiopathic urticaria within the past year.
- Asthma that is not well controlled or required emergency care, urgent care, hospitalization, or intubation during the past two years or that requires the use of oral or intravenous steroids.
- Type 1 or type 2 diabetes mellitus that is not well controlled (hemoglobin A1c \>8).
- Clinically significant autoimmune disease or immunodeficiency.
- Blood pressure \>=180/110 (stage 3 hypertension) on at least 2 measures.
- Documented diagnosis of a bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
- Significant bruising or bleeding difficulties with subcutaneous injections or blood draws.
- Malignancy that is active or treated malignancy for which there is no reasonable assurance of sustained cure, or malignancy that is likely to recur during the study period.
- Asplenia or functional asplenia.
- Current alcohol or drug abuse or addiction.
- Any medical, psychiatric, or social condition that, in the judgement of the investigator, is a contraindication to protocol participation. Co-enrollment guidelines: Co-enrollment in other treatment trials is restricted...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.