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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00057525 |
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Date of registration:
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03/04/2003 |
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Primary sponsor: |
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Public title:
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A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
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Scientific title:
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A Phase 1 Study of Safety and Immunogenicity of E. Coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00057525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Merlin L Robb, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr., Rockville, MD 20850 |
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Key inclusion & exclusion criteria
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Volunteers are eligible for this study if they meet all the following criteria:
- Citizens of the U.S.
- Age 18 to 40 years.
- For women, a negative serum pregnancy test will be required at study entry and within
24 hours prior to each vaccination, as well as verbal assurance that adequate birth
control measures are applied prior to initial vaccination and for 3 months after the
last vaccination.
- Good health as determined by medical history, physical examination, and clinical
judgment.
- Normal Baseline Clinical Laboratory Values at screening including:
- Complete Blood Count (CBC) including:
- White Blood Cell Count: 3.8 -10.8
- Red Blood Cell Count (Mill/MCL)
- Male: 4.20 - 5.80
- Female: 3.80 - 5.10
- Hemoglobin (G/DL)
- Male: 13.2 - 17.1
- Female: 11.7 - 15.5
- Hematocrit (%)
- Male: 38.5- 50.0
- Female: 35.0 - 45.0
- Platelet Count: 140 - 440 (THOUS/MCL)
- Differential
- Urine dipstick for protein and blood: negative or trace. If either is = 1+,
obtain complete urinalysis (UA). If microscopic UA confirms evidence of
hematuria or proteinuria = 1+, the volunteer is ineligible.
- Negative serology for HIV infection (ELISA test).
- CPK within normal limits
- Hepatic Function Tests including AST, ALT, ALK PHOS.
- Total bilirubin, BUN, serum creatinine, serum electrolytes
- Availability for at least 13 months of follow-up from the time of the screening
visit.
- Successful completion of the Test of Understanding defined as 90% correct with three
opportunities to take test. Errors will be reviewed with volunteer after each test.
- Commitment for trial participation and signature of the approved consent form.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anthrax
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Intervention(s)
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Biological: Alhdryogel or PBS
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Biological: Anthrax
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Secondary ID(s)
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Anthrax
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rPA-EC-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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