Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

NCT00103467•VaxGen

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.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•Healthy male or female aged 18 to 40 years old (inclusive) without significant physical or clinical laboratory abnormalities.
•Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
•For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 3 months of the study.
•Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
•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

•Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
•Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
•Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.
•Expected to be noncompliant with study visits or planning to move within 8 months.
•Body mass index of \>35 or \<19.
•Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
•Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
•HIV positive (by history or screening ELISA).
•Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
•Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
+10 more criteria

Locations (4)

Emory University School of Medicine

Atlanta, Georgia, United States

Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health

Baltimore, Maryland, United States

St. Louis University - SoLutions/SLUtest

St Louis, Missouri, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

June 1, 2003

Last Updated

June 24, 2005

Enrollment

100

Estimated participants

Conditions

Prevention of Anthrax Infection

Interventions

rPA102 Vaccine

BIOLOGICAL