Safety and Immunogenicity of a Hantaan Virus DNA Vaccine and a Puumala Virus DNA Vaccine, For The… (NCT04333459) | Clinical Trial Compass
UnknownPhase 2
Safety and Immunogenicity of a Hantaan Virus DNA Vaccine and a Puumala Virus DNA Vaccine, For The Prevention of Hemorrhagic Fever With Renal Syndrome
United States132 participantsStarted 2021-08-23
Plain-language summary
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine.
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
✓. Completion of Study Comprehension Quiz (minimum passing score of 80% with 2 attempts permitted).
✓. A subject must have a valid state or government-issued photo ID (eg, driver's license, military ID, or U.S. passport) \& be able to pass a background check in order to gain access to the base \& participate.
✓. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination with ECG and laboratory assessments prior to entry into the study
✓. Available and able to participate for all study visits and procedures
✓. Females subjects must have had a hysterectomy or bilateral oopherectomy or must be using an effective method of contraception\*\* from 30 days prior to the first study vaccination until 90 days after the last study vaccination.
✓. Female subjects who have not had a hysterectomy or bilateral oopherectomy must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
Exclusion criteria
✕. History of previous hantavirus vaccine.
✕. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
What they're measuring
1
The proportion of subjects in Group 1 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
Timeframe: 197 (+/- 2) days
2
The proportion of subjects in Group 3 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers.
Timeframe: 197 (+/- 2) days
Trial details
NCT IDNCT04333459
SponsorU.S. Army Medical Research and Development Command
. Ongoing participation in another clinical trial (those continuing through Day 197 will not join other new studies until their final visit)
✕. Receipt of licensed vaccines within 7 days before or after immunization (30 days for live vaccines)
✕. Any use of investigational drugs or vaccines within 30 days before starting the study.
✕. Ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
✕. Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, and/or laboratory screening test
✕. Pregnant or lactating female, or female who intends to become pregnant during the study period