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A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00057525
Recruitment Status : Completed
First Posted : April 7, 2003
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
DynPort Vaccine Company LLC, A GDIT Company

Tracking Information
First Submitted Date  ICMJE April 3, 2003
First Posted Date  ICMJE April 7, 2003
Last Update Posted Date June 30, 2011
Study Start Date  ICMJE April 2003
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
Official Title  ICMJE 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
Brief Summary This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.
Detailed Description This is a safety study with an open-label part (2 groups), followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind, sequential-group design with randomization and placebo-control within each of the 6 groups. Volunteers in each dose group will receive two IM injections at Day 0 and Month 1
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Anthrax
Intervention  ICMJE
  • Biological: Anthrax
    Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
  • Biological: Alhdryogel or PBS
    Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
Study Arms  ICMJE
  • Experimental: Anthrax vaccine with or without PBS
    Administor 1 dose 5 μg rPA with PBS (5 Volunteers)
    Intervention: Biological: Anthrax
  • Placebo Comparator: Placebo
    Doses will range from 5 _g to 100 _g rPA, and at each dose-level, rPA will either be combinedwith phosphate-buffered saline (PBS) or adsorbed to Alhydrogel
    Intervention: Biological: Alhdryogel or PBS
Publications * Brown BK, Cox J, Gillis A, VanCott TC, Marovich M, Milazzo M, Antonille TS, Wieczorek L, McKee KT Jr, Metcalfe K, Mallory RM, Birx D, Polonis VR, Robb ML. Phase I study of safety and immunogenicity of an Escherichia coli-derived recombinant protective antigen (rPA) vaccine to prevent anthrax in adults. PLoS One. 2010 Nov 5;5(11):e13849. doi: 10.1371/journal.pone.0013849.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date April 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00057525
Other Study ID Numbers  ICMJE rPA-EC-02
Anthrax
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, DynPort Vaccine Company, LLC
Study Sponsor  ICMJE DynPort Vaccine Company LLC, A GDIT Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Merlin L Robb, MD Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr., Rockville, MD 20850
PRS Account DynPort Vaccine Company LLC, A GDIT Company
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP