Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine (NCT05691530) | Clinical Trial Compass
CompletedPhase 1
Trial to Model Primary, Secondary, and Tertiary Dengue Using a Monovalent Vaccine
United States127 participantsStarted 2023-03-07
Plain-language summary
Background:
Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, dengue vaccines are limited and do not protect all people equally. One vaccine actually increased the risk of severe disease in some people and was taken off the market. Better vaccines are needed.
Objectives:
To test a potential new vaccine against dengue. To see if side effects and immune responses are different depending on a person's previous exposure to dengue.
Eligibility: Healthy people aged 18 to 59 years.
Design:
Participants will visit the clinic 11 times in 7 months; 9 of those visits will be in the first 2 months. Two additional visits are optional.
Participants will be screened. They will have a physical exam with urine and blood tests. They will complete a survey about their travel history.
Participants may opt to have a lymph node aspiration before receiving the study vaccine. An area in the left armpit will be numbed. A needle will be inserted to remove some cells from a lymph node.
The vaccine will be injected into the fat under the skin of the participant's upper left arm.
Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks. Then they will return for a provider visit and blood draws after longer intervals up to 7 months. The lymph node aspiration may be repeated at later visits.
Participants may opt to return for a last visit after 12 months.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all the following criteria:
* Aged 18 to 59 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 vaccine or in the 28 days following the dose of vaccine. For participants opting for lymph node (LN) fine needle aspiration (FNA) on day 57, they must be willing to forgo any vaccine through final LN FNA.
* For individuals who can become pregnant: use of at least one method of highly effective contraception from the invitation to participate in the trial through day 60 after vaccination.
* 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 Centers for Disease Control and Prevention (CDC) from 1 month before vaccination through day 57
* Baseline absolute neutrophil count (ANC) \> 750 cells/microL.
* Baseline creatinine \< 1.5 mg/dL.
* Baseline ALT \< 1.25 x upper limit of normal.
* Serologic evidence of previous dengue virus infection indicative of either one previous DENV1, 2, or 4 infection or infection with at least two different serotypes.
* For the flavivirus-naïve group, they must have no history of flavivirus vaccination, medical illness concerning …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial that has already completed, what do the safety results — like the rates of local and systemic side effects they were tracking — mean for how safe this approach might be, and is that data publicly available for us to review together?
2This trial used a monovalent dengue vaccine to deliberately model primary, secondary, and tertiary dengue infection, which sounds like it involved intentional virus exposure — can you explain exactly what that process involved and what it would mean for someone's health in the short and long term?
3The trial was measuring things like peak viremia, which means the level of virus in the blood — what did findings like that tell researchers about how the body responds to dengue, and how does that relate to my own situation?
4Because this was an early-stage Phase 1 study focused mainly on safety and immune response rather than proving a treatment works, would participating in or following research like this change any of my current treatment options or decisions?
5Are there follow-on trials building on this completed study that might be relevant to my case, or is standard dengue management still the most evidence-backed path for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Local Adverse Events (AEs)
Timeframe: Through day 28 after vaccine administration
2
Number of Participants With Systemic Adverse Events (AEs)
Timeframe: Through day 28 after vaccine administration
3
Severity of Local Adverse Events (AEs) by Grade
Timeframe: Through day 28 after vaccine administration
4
Severity of Systemic Adverse Events (AEs)
Timeframe: Through day 28 after vaccine administration
5
Number of Participants With Unexpected Adverse Events (AEs)
Timeframe: Through day 28 after vaccine administration
6
Number of Participants With Serious Adverse Events (AEs)
Timeframe: Through day 180 after vaccine administration
7
Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 28
Timeframe: Day 28 and day 0
Trial details
NCT IDNCT05691530
SponsorNational Institutes of Health Clinical Center (CC)