Clinical trial NCT00332956: Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
Official title: A Phase 2 (a), Dose-Blinded, Block-Randomized, Dose and Schedule Selection Study to Evaluate the Immunogenicity and Safety of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Lead sponsor: DynPort Vaccine Company LLC, A GDIT Company
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: Primary Objective: To select a dosage and schedule of rF1V vaccine for further study based on the immune response to F1 and V antigens up to Day 210.

Secondary Objectives: 1) To assess the safety of three injections of rF1V vaccine administered IM at two dosage levels.

2) To assess the onset and duration of the humoral immune response to F1 and V antigens.

3) To assess the humoral immune response to rF1V antigen. 4) To collect and store blood samples for future plague related research.

Exploratory Objectives:

To assess additional humoral immune responses to rF1V vaccine antigens.

Eligibility criteria: Inclusion Criteria:

1. Male or Female age 18 to 55 years
2. In good health
3. Acceptable ranges for the laboratory parameters
4. 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.
5. Willing to have his/her blood samples stored for future plague research studies.
6. Signed the ICF and HIPPA and successfully completed the Test of Understanding (90% correct).
7. Agrees not to donate blood until at least 90 days following the last vaccination.
8. Volunteer is willing to comply with the requirements of the protocol through the post-vaccination Day 540 visit.
9. 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.

Exclusion Criteria:

1. A history of plague disease or have previously received any plague vaccine.
2. Active tuberculosis or other systemic infectious process.
3. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin, tobramycin, amikacin)
4. Positive prescreening for human immunodeficiency virus (HIV); hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg).
5. A history of immunodeficiency or chronic illness requiring continuous or frequent medical intervention, acute/chronic untreated conditions, autoimmune disease or use of immunosuppressive medications.
6. Chronic, severe or recurrent joint pain (4 or more occurrences per year) or arthritis of any type.
7. A positive result on a urine drug screen that tests for common substances of abuse such as amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids.
8. 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.
9. Receipt of any blood product or immune globulin in the previous 6 months.
10. Receipt of any investigational vaccine in the previous 6 months
11. Donation of blood within 56 days prior to first vaccination or at any time prior to Day 210 visit.
12. 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.
13. A clinically significant abnormality on the ECG.
14. A body mass index \> or equal to 35 kg/m2
15. 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.
16. Personal history of multiple sclerosis, since immune system stimulation may exacerbate this disorder.
17. Occupational or other responsibilities that would prevent completion of participation in the study.
18. Licensed vaccines are not exclusionary but should be given at least 2 weeks before or after immunization (if live vaccine, 60 days before or after immunization) to avoid potential confusion of adverse reactions.
19. Screening laboratory values not within acceptable ranges.
20. A history of anaphylaxis or other serious adverse reactions to vaccines.
21. The female volunteer is pregnant
22. Receipt of therapy with immunosuppressive agents, including high-dose systemic corticosteroids (i.e., prednisone-equivalent dose of \> or equal to 20 mg/day), within 3 months prior to or during the study.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.
timeFrame: Day 210 Interim Analysis
measure: To access the onset and duration of the humoral immune response to F1 and V antigens
timeFrame: Final Clinical Study Reort
measure: To assess the humoral immune response to rF1V antigen
timeFrame: Final Clinical Study Report
measure: To collect and store blood samples for future plague related research.
timeFrame: Through Study Day 540
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Alta Clinical Research, LLC
state: Arizona
city: San Francisco
country: United States
facility: Benchmark Research
state: California
city: West Palm Beach
country: United States
facility: Palm Beach Research
state: Florida
city: Lexington
country: United States
facility: University of Kentucky - Dept. of Infectious Disease
state: Kentucky
city: St. Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Missoula
country: United States
facility: Infectious Disease Specialists, PC
state: Montana
city: Omaha
country: United States
facility: Meridian clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc.
state: Pennsylvania
Study officials:
affiliation: Benchmark Research
name: Ivor Emmanual, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Center of Neveda
name: Steven Folkerth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky - Department of Infectious Disease
name: Richard Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alta Clinical Research, LLC
name: Vicki Grieff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meridian Clinical Research, LLC
name: John Jacobsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Physicians Research, Inc.
name: Keith Reisinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Disease Specialists, PC
name: George Risi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sundance Clinical Research
name: L. Tyler Wadsworth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach Research
name: Iaasc Marcadis, MD
role: PRINCIPAL_INVESTIGATOR
References: