Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age
Dynavax Technologies Corporation
Summary
This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine
Description
This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial. Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adults 18 to 55 years of age 2. Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition. 3. Able to comply with the protocol schedule and procedures 4. Able and willing to provide written informed consent 5. If female of child-bearing pot…
Interventions
- BiologicalrF1V-1018
Regimen 1
- BiologicalrF1V-1018
Regimen 2
- BiologicalrF1V-1018
Regimen 3
- BiologicalrF1V-1018
Regimen 4
- BiologicalrF1V-1018
Regimen 5
- BiologicalrF1V-1018
Regimen 6
Locations (3)
- AMR- MiamiMiami, Florida
- AMR- El DoradoEl Dorado, Kansas
- AMR- Las VegasLas Vegas, Nevada