A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00057525 |
Recruitment Status :
Completed
First Posted : April 7, 2003
Last Update Posted : June 30, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anthrax | Biological: Anthrax Biological: Alhdryogel or PBS | Phase 1 |
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 |

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 |

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057525
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 |
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 |
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 Key Record Dates |
Last Update Posted: | June 30, 2011 |
Last Verified: | June 2011 |
Anthrax |
Anthrax Bacillaceae Infections Gram-Positive Bacterial Infections Bacterial Infections |