Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

NCT00332956 | Completed Phase 2 DMC

• 1 other identifier: rF1V-02(a)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (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

  Day 210 Interim Analysis

Secondary Outcomes (4)

• To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.

  Day 210 Interim Analysis

• To access the onset and duration of the humoral immune response to F1 and V antigens

  Final Clinical Study Reort

• To assess the humoral immune response to rF1V antigen

  Final Clinical Study Report

• To collect and store blood samples for future plague related research.

  Through Study Day 540

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Volunteers will be vaccinated with 80 mcg rF1V vaccine on Study Days 0 , 28, 182

Biological: rFIV vaccine

Group 2

ACTIVE COMPARATOR

Volunteers will be vaccinated with 80 mcg of rF1V vaccine at Study Days 0, 56, 182

Biological: rF1V vaccine

Group 3

ACTIVE COMPARATOR

Volunteers will be vaccinated with 160 mcg rF1V vaccine given on Study Days 0, 28, 182

Biological: rF1V vaccine

Group 4

ACTIVE COMPARATOR

Volunteers will be vaccinated with 160 mcg rf1V vaccine on Study Days 0, 56, 182

Biological: rF1V vaccine 160 mcg given on Study Days 0, 56, 182

Interventions

rFIV vaccine BIOLOGICAL

rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182

Also known as: Recombinant Plague Vaccine rF1V

Group 1

rF1V vaccine BIOLOGICAL

rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182

Also known as: Recombinant Plague Vaccine rF1V

Group 2

rF1V vaccine 160 mcg given on Study Days 0, 56, 182 BIOLOGICAL

rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182

Also known as: Recombinant Plague Vaccine rF1V

Group 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Female volunteers must be of non-childbearing potential or must not be pregnant. Must use 2 types of acceptable for of FDA approved contraception or abstinent.

You may not qualify if:

• 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).
• 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.
• Receipt of any blood product or immune globulin in the previous 6 months.
• Receipt of any investigational vaccine in the previous 6 months
• Donation of blood within 56 days prior to first vaccination or at any time prior to Day 210 visit.
• Receipt of any investigational drug therapy within 30 days before the first dose of rF1V or intent to receive any other investigational drug therapy before the post-vaccination Day 540 visit.
• A clinically significant abnormality on the ECG.
• A body mass index \> or equal to 35 kg/m2
• Acute illness, evidence of significant active infection or systemic disease at time of enrollment that in the opinion of the Investigator would place the volunteer at an unacceptable risk for injury.

Sponsors & Collaborators

• DynPort Vaccine Company LLC, A GDIT Company: lead

Study Sites (9)

Alta Clinical Research, LLC

Tucson, Arizona, 85745, United States

Location

Benchmark Research

San Francisco, California, 94102, United States

Location

Palm Beach Research

West Palm Beach, Florida, 33409, United States

Location

University of Kentucky - Dept. of Infectious Disease

Lexington, Kentucky, 40536, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Infectious Disease Specialists, PC

Missoula, Montana, 59802, United States

Location

Meridian clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Primary Physicians Research, Inc.

Pittsburgh, Pennsylvania, 15241, United States

Location

Study Officials

• Ivor Emmanual, MD

  Benchmark Research

  PRINCIPAL INVESTIGATOR

• Steven Folkerth, MD

  Clinical Research Center of Neveda

  PRINCIPAL INVESTIGATOR

• Richard Greenberg, MD

  University of Kentucky - Department of Infectious Disease

  PRINCIPAL INVESTIGATOR

• Vicki Grieff, MD

  Alta Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

• John Jacobsen, MD

  Meridian Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

• Keith Reisinger, MD

  Primary Physicians Research, Inc.

  PRINCIPAL INVESTIGATOR

• George Risi, MD

  Infectious Disease Specialists, PC

  PRINCIPAL INVESTIGATOR

• L. Tyler Wadsworth, MD

  Sundance Clinical Research

  PRINCIPAL INVESTIGATOR

• Iaasc Marcadis, MD

  Palm Beach Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 2, 2011

Record last verified: 2011-11

Locations

US (9)