Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332956
• Other study ID #: rF1V-02(a)
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2006
• Last updated: November 28, 2011
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: DynPort Vaccine Company LLC, A CSC Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• rFIV vaccine
rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182
• rF1V vaccine
rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182
• rF1V vaccine
rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182
• rF1V vaccine 160 mcg given on Study Days 0, 56, 182
rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182

Locations

Country	Name	City	State
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	University of Kentucky - Dept. of Infectious Disease	Lexington	Kentucky
United States	Infectious Disease Specialists, PC	Missoula	Montana
United States	Meridian clinical Research, LLC	Omaha	Nebraska
United States	Primary Physicians Research, Inc.	Pittsburgh	Pennsylvania
United States	Benchmark Research	San Francisco	California
United States	Sundance Clinical Research	St. Louis	Missouri
United States	Alta Clinical Research, LLC	Tucson	Arizona
United States	Palm Beach Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
DynPort Vaccine Company LLC, A CSC Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.		Day 210 Interim Analysis	Yes
Secondary	To access the onset and duration of the humoral immune response to F1 and V antigens		Final Clinical Study Reort	No
Secondary	To assess the humoral immune response to rF1V antigen		Final Clinical Study Report	No
Secondary	To collect and store blood samples for future plague related research.		Through Study Day 540	No