A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumal… (NCT02776761) | Clinical Trial Compass
CompletedPhase 1
A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine
United States27 participantsStarted 2016-08-30
Plain-language summary
This is a single-center, randomized, single-blinded study of the Hantaan virus HTNV DNA vaccine alone, Puumala virus PUUV DNA vaccine alone, and mixed Hantaan/Puumala HTNV/PUUV DNA vaccines delivered intramuscularly IM by the needle-free PharmaJet Stratus DSJI device.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion Criteria:
* Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at the time of screening
* Have provided written informed consent before screening
* Free of clinically significant health problems as determined by pertinent medical history and clinical examination prior to entry into the study
* Available and able to participate for all study visits and procedures
* Females, if not abstinent, are known to be at least 1 year post-menopausal (defined as no menses for 12 consecutive months) or willing to use an effective method of contraception (eg, hormonal contraception to include oral and implantable options, diaphragm, cervical cap, intrauterine device, condom, or anatomical sterility \[self or partner\]) for the duration of study participation (from the date of screening) until at least 3 months after the last injection
* Negative hantavirus PsVNA test result at screening
Exclusion Criteria:
* History or serologic evidence of prior infection with any hantavirus or prior participation in an HTNV or PUUV vaccine trial
* History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
* Ongoing participation in another clinical trial (subjects continuing through Day 365 will not join other new studies until their final visit)
* Receipt of licensed vaccines within 14 days before or after immunization (30 days for live vaccines)
* Ability to observe possible local reactions at the eligible injection…
What they're measuring
1
Hantaan Vaccine: Number of Adverse Events
Timeframe: 365 days
2
Puumala Vaccine: Number of Adverse Events
Timeframe: 365 days
3
Hantaan/Puumala Vaccine: Number of Adverse Events
Timeframe: 365 days
Trial details
NCT IDNCT02776761
SponsorU.S. Army Medical Research and Development Command