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Home > "A" Clinical Trials Conditions > A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults  A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
For Condition: Anthrax
Status: Recruiting
Sponsor(s): DynPort Vaccine Company ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/40 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 70
Location and Contact Information:
Overall Study Official:
MerlinRobb, Principal Investigator, Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr., Rockville, MD 20850
Walter Reed Army Institute of Research / Henry M. Jackson Foundation Vaccine Clinical Research Center, 1600 East Gude Dr *Recruiting*
Rockville, Maryland, 20850
United States
Recruiting MJ Humphries 301-251-5000
Additional Information:
Study ID Numbers: rPA-EC-02; Anthrax
Study Start Date: April 2003
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057525
Other Anthrax Studies:
1. Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
2. rPA (Anthrax)
3. A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
4. Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
Related Studies:
Other Anthrax Clinical Trials
Other Maryland Clinical Trials
Other Rockville Clinical Trials
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
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