Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant

Completed · Phase 2

Conditions studied: Plague Vaccine

In brief

Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).

Key facts

Study ID

NCT01122784

Run by

DynPort Vaccine Company LLC, A GDIT Company

People needed

402

Starts

2010-07-01

Expected to finish

2012-07-01

Last updated by the study team

2020-07-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The volunteer has signed the ICF and the HIPAA authorization and has successfully completed (at least 90% correct) the Test of Understanding.
• The volunteer is a male or female 18 to 55 years of age (inclusive) at the time of the screening visit.
• The volunteer is in good health as determined by the screening physician based upon medical history and physical examination, including vital signs within acceptable ranges.
• The volunteer has acceptable ranges for the laboratory parameters.
• The volunteer has no clinically significant abnormalities on ECG.
• The volunteer agrees not to donate blood, plasma or blood components for therapeutic or research purposes, except to meet requirements of this study, at any time during the course of the study.
• The volunteer is willing to have his or her blood samples stored for future plague research studies.
• The volunteer is willing to comply with the requirements of the protocol through the end of the study.
• Female volunteers must be of non-childbearing potential or, if of childbearing potential, must not be pregnant or lactating and must use acceptable contraception.

You may not qualify if…

• History of plague exposure or disease or previous vaccination with any plague vaccine.
• History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin).
• History of anaphylaxis or other serious adverse reactions to vaccines or aluminum.
• Active tuberculosis or other systemic infectious process by review of systems and PE.
• History of chronic illness requiring continuous or frequent medical intervention or acute/chronic untreated conditions, multiple sclerosis, immunodeficiency, autoimmune or immunosuppressive disease or use of immunosuppressive medications.
• Diabetes mellitus of any type requiring treatment with insulin or oral hypoglycemic drugs.
• History of chronic, severe or recurrent joint pain (four or more clinically significant occurrences per year requiring treatment for remission) or arthritis of any etiology other than osteoarthritis.
• Previous diagnosis of any serious psychiatric disorder.
• Acute illness, evidence of significant active infection or evidence of systemic disease at the time of enrollment.
• Oral temperature > 99.5°F.
• Receipt of chemotherapeutic and immunosuppressive agents, including high-dose systemic glucocorticoids (i.e., prednisone-equivalent dose of > 20 mg/day).
• Receipt of blood, any blood product or immune globulin.
• Receipt of any investigational drug therapy or investigational implantable device or intent to receive any other investigational drug therapy or device throughout their study participation.
• Receipt of any investigational vaccine.
• Receipt or intent of any licensed nonliving vaccine.
• Receipt of any licensed live vaccine within 60 days before Vaccination 1
• Donation of more than 400 mL of blood 8 weeks before Vaccination 1.
• Occupational or other responsibilities that would prevent completion of participation in the study.
• Weight or body mass index (BMI) outside acceptable ranges.
• Positive screening laboratory test for HIV antibody, HCV antibody or HBsAg.
• A positive result on a urine drug screen that tests for common substances of abuse.
• Female volunteer is pregnant or lactating.
• The volunteer is currently on active duty in the U.S. military, or a member or relative of the clinical site study staff.

Where it is running

• Benchmark Research — San Francisco, California, United States
• Apex Research Institute — Santa Ana, California, United States
• Johnson County Clinical Trials — Lenexa, Kansas, United States
• Heartland Reseach Assoicates, LLC — Wichita, Kansas, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• WRAIR Clinical Trials Center — Silver Spring, Maryland, United States
• Center for Pharmceutical Research — Kansas City, Missouri, United States
• Rochester Clinical Research — Rochester, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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