Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
United States400 participantsStarted 2006-05
Plain-language summary
This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.
Who can participate
Age range18 Years – 55 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
✓. Male or Female age 18 to 55 years
✓. In good health
✓. Acceptable ranges for the laboratory parameters
✓. Normal ECG. If a volunteer is reported to have a benign ECG abnormality(e.g., sinus bradycardia) the results may be discussed with the medical monitors for the study.
✓. Willing to have his/her blood samples stored for future plague research studies.
✓. Signed the ICF and HIPPA and successfully completed the Test of Understanding (90% correct).
✓. Agrees not to donate blood until at least 90 days following the last vaccination.
✓. Volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 540 visit.
Exclusion criteria
✕. A history of plague disease or have previously received any plague vaccine.
✕. Active tuberculosis or other systemic infectious process.
✕. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin)
✕. Positive prescreening for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg).
✕
What they're measuring
1
To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210
Timeframe: Day 210 Interim Analysis
Trial details
NCT IDNCT00332956
SponsorDynPort Vaccine Company LLC, A GDIT Company
. A history of immunodeficiency or chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease or use of immunosuppressive medications.
✕. Chronic, severe or recurrent joint pain (4 or more occurrences per year) or arthritis of any type.
✕. A positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
✕. A previous diagnosis of any serious psychiatric disorder. For this purpose, serious psychiatric disorder is defined as illness requiring hospitalization within the previous 12 months; routine administration of more than one medication to control anxiety, mood or sleep disorder; or history of suicide attempt.