NCT00057525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

April 3, 2003

Last Update Submit

June 29, 2011

Conditions

Anthrax

Keywords

Anthrax

Study Arms (2)

Anthrax vaccine with or without PBS

EXPERIMENTAL

Administor 1 dose 5 μg rPA with PBS (5 Volunteers)

Biological: Anthrax

Placebo

PLACEBO COMPARATOR

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

Interventions

AnthraxBIOLOGICAL

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

Anthrax vaccine with or without PBS
Alhdryogel or PBSBIOLOGICAL

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

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Rockville, Maryland, 20850, United States

Location

Related Publications (1)

  • 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.

    PMID: 21079762DERIVED

MeSH Terms

Conditions

Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic Chemicals

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2003

First Posted

April 7, 2003

Study Start

April 1, 2003

Primary Completion

April 1, 2004

Study Completion

August 1, 2004

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

US(1)