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

• ClinicalTrials.gov Identifier: NCT00057525
• Recruitment Status: Completed
• First Posted: April 7, 2003
• Last Update Posted: June 30, 2011
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company
• Information provided by: DynPort Vaccine Company LLC, A GDIT Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anthrax	Biological: Anthrax; Biological: Alhdryogel or PBS	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: April 2003
• Actual Primary Completion Date: April 2004
• Actual Study Completion Date: August 2004

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anthrax vaccine with or without PBS; Administor 1 dose 5 μg rPA with PBS (5 Volunteers)	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
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	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

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr

Rockville, Maryland, United States, 20850

Sponsors and Collaborators

DynPort Vaccine Company LLC, A GDIT Company

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Chief Medical Officer, DynPort Vaccine Company, LLC
• ClinicalTrials.gov Identifier: NCT00057525
• Other Study ID Numbers: rPA-EC-02; Anthrax
• First Posted: April 7, 2003
• Last Update Posted: June 30, 2011
• Last Verified: June 2011

Keywords provided by DynPort Vaccine Company LLC, A GDIT Company:

Anthrax

Additional relevant MeSH terms:

Anthrax; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections