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

This study has been completed.
Sponsor:
Information provided by:
DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier:
NCT00057525
First received: April 3, 2003
Last updated: June 29, 2011
Last verified: June 2011

April 3, 2003
June 29, 2011
April 2003
April 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00057525 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
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

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Anthrax
  • 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
  • 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
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.
 
Completed
70
August 2004
April 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057525
rPA-EC-02, Anthrax
Yes
Chief Medical Officer, DynPort Vaccine Company, LLC
DynPort Vaccine Company LLC, A CSC Company
Not Provided
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
DynPort Vaccine Company LLC, A CSC Company
June 2011

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