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

NCT00103467 | Completed Phase 1

• 1 other identifier: VAX005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Prevention of Anthrax Infection

Outcome Measures

Primary Outcomes (1)

• Safety and immunogenicity of 3 doses over 4 different dose ranges.

Interventions

rPA102 Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
• Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
• Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.
• Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.
• Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.

Sponsors & Collaborators

• VaxGen: lead

Study Sites (4)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

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

Baltimore, Maryland, 21205, United States

Location

St. Louis University - SoLutions/SLUtest

St Louis, Missouri, 63104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2005
• First Posted: February 9, 2005
• Study Start: June 1, 2003
• Last Updated: June 24, 2005

Record last verified: 2005-02

Locations

US (4)