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.

Study Overview

• Status: Completed
• Conditions: Anthrax
• Intervention / Treatment: Biological: Anthrax; Biological: Alhdryogel or PBS

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: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: April 3, 2003
• First Submitted That Met QC Criteria: April 4, 2003
• First Posted (Estimate): April 7, 2003

Study Record Updates

• Last Update Posted (Estimate): June 30, 2011
• Last Update Submitted That Met QC Criteria: June 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Anthrax
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Bacillaceae Infections; Anthrax
• Other Study ID Numbers: rPA-EC-02; Anthrax