Clinical trial NCT00103467: Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Official title: A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention of Anthrax Infection
Lead sponsor: VaxGen
Sponsor class: INDUSTRY
First posted: 2005-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.
* 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.
* Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.
* Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
* Use of systemic chemotherapy within 5 years prior to study.
* History of Guillain-Barre Syndrome.
* 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.

Primary outcomes:
measure: Safety and immunogenicity of 3 doses over 4 different dose ranges.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health
state: Maryland
city: St. Louis
country: United States
facility: St. Louis University - SoLutions/SLUtest
state: Missouri
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: