A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults - Full Text View

Purpose

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	Intervention	Phase
Anthrax	Biological: Anthrax Biological: Alhdryogel or PBS	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Anthrax

Genetic and Rare Diseases Information Center resources: Anthrax

U.S. FDA Resources

Further study details as provided by DynPort Vaccine Company LLC, A CSC Company:


Enrollment:	70
Study Start Date:	April 2003
Study Completion Date:	August 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057525

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 CSC 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

No publications provided by DynPort Vaccine Company LLC, A CSC Company

Additional 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 History of Changes
Other Study ID Numbers:	rPA-EC-02, Anthrax
Study First Received:	April 3, 2003
Last Updated:	June 29, 2011
Health Authority:	United States: Food and Drug Administration

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


Anthrax

Additional relevant MeSH terms:


Anthrax Bacillaceae Infections Bacterial Infections Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on March 02, 2015