Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V

NCT00097396 | Completed Phase 1 DMC

• 1 other identifier: rF1V-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.

Conditions

Pneumonic Plague; Preventive Therapy

Keywords

plague; recombinant plague vaccine; vaccine; plague vaccine; Protection against pneumonic plague

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an IM injection at four ascending dose-levels.

Secondary Outcomes (2)

• To evaluate immunogenicity of a two-dose schedule of rF1V vaccine when given as an IM injection at four ascending dose-levels

• To collect and store serum samples for future immunogenicity assays (e.g. ELISA).

Interventions

rF1V vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The volunteer is male or female and 18 to 40 years of age (inclusive) at the time of the first dose of investigational product
• Good health as determined by screening medical history and physical examination
• The volunteer has the following laboratory parameters within normal range: total WBC, Hemoglobin, platelets, LFT (AST, ALT, ALP, Bilirubin) and/or ≤ 1+ proteinuria. Other laboratory parameters must be within 10 % of the upper or lower limits of the normal range of the University of Kentucky clinical laboratory and not clinically significant as assessed by the Investigator and/or Sponsor Medical Monitor.
• The volunteer has a normal electrocardiogram (ECG). However, if a potential volunteer is reported to have a benign ECG abnormality (e.g., sinus bradycardia) the results may be discussed with the Sponsor Medical Monitor and Covalent Medical Monitor. With the agreement of the Investigator, Covalent Medical Monitor and Sponsor Medical Monitor and documentation of the consultation in the volunteer's study record the Investigator may include the volunteer in the study.
• The volunteer is willing to have his or her blood samples stored for future plague research studies.
• The volunteer has signed the Informed Consent Form, successfully completed (at least 90 % correct) the Test of Understanding, and has signed the HIPAA authorization form.
• The volunteer agrees not to donate blood for at least 30 days following vaccination.
• The volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 180 (± 7 days) visit.
• Female volunteers must be of non-childbearing potential (i.e., surgically sterilized or postmenopausal), or must not be pregnant (as indicated by a negative serum pregnancy test within 24 hours prior to rF1V administration) or nursing, and must use two types of an acceptable form of FDA-approved contraception (barrier method, Depo-Provera, Norplant, Ortho Evra (birth control patch), oral contraceptives) through 30 days after the second (final) vaccination of rF1V (i.e. Day 58). If abstinent, two forms of birth control are not required
• The volunteer must be an active participant enrolled in Phase 1 rF1V-01 protocol - Cohort 4 (160 ug) completing day 180 procedures as defined in rF1V-01 protocol
• Have good health as determined by screening medical history and physical examination
• Have a blood potassim level of no less than 3.6 mEq/mL and have no clinically significant abnormalities on other laboratory safety tests from the study Day 180 assessments
• The volunteer has signed the informed consent form for Cohort 4 Extension
• The volunteers agrees not to donate blood for at least 30 days following vaccination
• The volunteer is willing to comply with the requirements of the protocol from the day of vaccination Study Day E-0 (-1) through Study Day E-180 (+/- 14 days)final visit

You may not qualify if:

• Have a history of plague disease or have received any plague vaccine.
• Have active tuberculosis or other systemic infectious process by review of systems and physical examination.
• Have a history of allergy to kanamycin or aminoglycosides.
• Positive for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
• Have a history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease, or use of immunosuppressive medications.
• The volunteer has chronic, severe or recurrent joint pain or arthritis of any etiology.
• The volunteer has a positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and cannabinoids. (If positive on screen, confirmatory testing shall be performed where applicable).
• The volunteer has 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.
• The volunteer has received any blood products or immune globulin in the previous six months.
• The volunteer has donated blood within the past 56 days.
• The volunteer received any investigational drug therapy within 30 days before the first dose of rF1V or intends to receive any other investigational drug therapy before the post-vaccination Day 180 (± 7 days) visit.
• The volunteer has a clinically significant abnormality on the ECG.
• The volunteer has a body mass index 40 kg/m2 or is greater than or equal to 100 lbs over the ideal body weight.
• The volunteer has an acute illness, evidence of significant active infection, or evidence of systemic disease at time of enrollment that in the opinion of the Investigator would place the volunteer at an unacceptable risk for injury.
• Have temperature greater than or equal to 100º F on the day of scheduled 1st vaccination.

Sponsors & Collaborators

• DynPort Vaccine Company LLC, A GDIT Company: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Links

• sponsor website

MeSH Terms

Conditions

Plague

Condition Hierarchy (Ancestors)

Yersinia Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• Richard N Greenberg, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2004
• First Posted: November 24, 2004
• Study Start: November 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

US (1)