Combination HTNV and PUUV DNA Vaccine (NCT03718130) | Clinical Trial Compass
CompletedPhase 1
Combination HTNV and PUUV DNA Vaccine
United States61 participantsStarted 2019-07-10
Plain-language summary
To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults
Who can participate
Age range18 Years – 49 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
* Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
* Have provided written informed consent before screening
* Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination
* Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
* An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.
* Available and able to participate for all study visits and procedures
* Sexually active men a…
What they're measuring
1
Summary of Solicited Local Adverse Events (AEs)
Timeframe: Days 0-14 after injection
2
Summary of Solicited Systemic Adverse Events (AEs)
Timeframe: Days 0-14 after injection
Trial details
NCT IDNCT03718130
SponsorU.S. Army Medical Research and Development Command