View Clinical Trial (Medical Research Study)
A Randomized, Single-Blinded Study to Evaluate the Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant - NCT01122784-67207(Clinical Trial 633835)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Wichita |
|
State:
|
|
KS |
| Zip Code: |
|
67207 |
| Conditions: |
|
Healthy Volunteers |
| Purpose: |
|
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).
|
| Study summary: |
|
The objectives of this trial are: to compare the safety of rF1V vaccine administered in two
different schedules through 28 days after each vaccination and cumulatively to Day 210; to
compare the immunogenicity of rF1V vaccine administered in two different schedules through
28 days after Vaccination 3; to compare the safety and immunogenicity of rF1V vaccine
administered by two different schedules through 12 months after Vaccination 3; and to assess
the contribution of the adjuvant to the immunogenicity of the rF1V antigen. |
| Criteria: |
|
Inclusion Criteria:
1. The volunteer has signed the ICF and the HIPAA authorization and has successfully
completed (at least 90% correct) the Test of Understanding.
2. The volunteer is a male or female 18 to 55 years of age (inclusive) at the time of
the screening visit.
3. 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.
4. The volunteer has acceptable ranges for the laboratory parameters.
5. The volunteer has no clinically significant abnormalities on ECG.
6. 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.
7. The volunteer is willing to have his or her blood samples stored for future plague
research studies.
8. The volunteer is willing to comply with the requirements of the protocol through the
end of the study.
9. Female volunteers must be of non-childbearing potential or, if of childbearing
potential, must not be pregnant or lactating and must use acceptable contraception.
Exclusion Criteria:
1. History of plague exposure or disease or previous vaccination with any plague
vaccine.
2. History of allergy to kanamycin or other aminoglycosides (e.g., gentamicin,
tobramycin, amikacin).
3. History of anaphylaxis or other serious adverse reactions to vaccines or aluminum.
4. Active tuberculosis or other systemic infectious process by review of systems and PE.
5. 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.
6. Diabetes mellitus of any type requiring treatment with insulin or oral hypoglycemic
drugs.
7. 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.
8. Previous diagnosis of any serious psychiatric disorder.
9. Acute illness, evidence of significant active infection or evidence of systemic
disease at the time of enrollment.
10. Oral temperature > 99.5°F.
11. Receipt of chemotherapeutic and immunosuppressive agents, including high-dose
systemic glucocorticoids (i.e., prednisone-equivalent dose of > 20 mg/day).
12. Receipt of blood, any blood product or immune globulin.
13. 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.
14. Receipt of any investigational vaccine.
15. Receipt or intent of any licensed nonliving vaccine.
16. Receipt of any licensed live vaccine within 60 days before Vaccination 1
17. Donation of more than 400 mL of blood 8 weeks before Vaccination 1.
18. Occupational or other responsibilities that would prevent completion of participation
in the study.
19. Weight or body mass index (BMI) outside acceptable ranges.
20. Positive screening laboratory test for HIV antibody, HCV antibody or HBsAg.
21. A positive result on a urine drug screen that tests for common substances of abuse.
22. Female volunteer is pregnant or lactating.
23. The volunteer is currently on active duty in the U.S. military, or a member or
relative of the clinical site study staff. |
|
|
|
|
|
|
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
October 8, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|