Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Study Details
Study Description
Brief Summary
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Safety and immunogenicity of 3 doses over 4 different dose ranges. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Able to understand the study and give written informed consent. A signed informed consent must be in place before the initiation of any study interventions.
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Healthy male or female aged 18 to 40 years old (inclusive) without significant physical or clinical laboratory abnormalities.
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Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
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For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 3 months of the study.
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Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
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Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.
Exclusion Criteria:
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Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
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Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
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Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.
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Expected to be noncompliant with study visits or planning to move within 8 months.
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Body mass index of >35 or <19.
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Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
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Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
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HIV positive (by history or screening ELISA).
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Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
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Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
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History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
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Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
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Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.
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Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.
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Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.
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Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.
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Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
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Use of systemic chemotherapy within 5 years prior to study.
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History of Guillain-Barre Syndrome.
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In addition to the conditions listed above, the following may qualify as a reason to exclude a volunteer from the study: fever along with moderate or serious illness within 3 days of vaccination or any condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the study evaluations. Pending resolution of these symptoms, a volunteer may be reconsidered for vaccination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University School of Medicine | Atlanta | Georgia | United States | 30322 |
| 2 | Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health | Baltimore | Maryland | United States | 21205 |
| 3 | St. Louis University - SoLutions/SLUtest | St. Louis | Missouri | United States | 63104 |
| 4 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- VaxGen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAX005