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

Primary Purpose

Anthrax

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anthrax
Alhdryogel or PBS
Sponsored by
DynPort Vaccine Company LLC, A GDIT Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anthrax focused on measuring Anthrax

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anthrax vaccine with or without PBS

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 3, 2003
Last Updated
June 29, 2011
Sponsor
DynPort Vaccine Company LLC, A GDIT Company
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1. Study Identification

Unique Protocol Identification Number
NCT00057525
Brief Title
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
DynPort Vaccine Company LLC, A GDIT Company

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
Keywords
Anthrax

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anthrax vaccine with or without PBS
Arm Type
Experimental
Arm Description
Administor 1 dose 5 μg rPA with PBS (5 Volunteers)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Anthrax
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Alhdryogel or PBS
Intervention Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merlin L Robb, MD
Organizational Affiliation
Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr., Rockville, MD 20850
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21079762
Citation
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.
Results Reference
derived

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

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