A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers
- 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 18-55 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 2 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.
- Prior history of, or known exposure to any form of B. anthracis or any anthrax
- 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, or emergency first responders.
- Expected to be noncompliant with study visits or planning to move within 12 months.
- Body mass index of >35 or <19.
- Known allergy to aluminum hydroxide, kanamycin, or any other aminoglycoside
antibiotics (such as gentamicin).
- Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or
- 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
- 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
- Received or plans to receive licensed killed vaccines within 14 days of study
- Received or plans to receive immunoglobulin or other blood products within 60 days of
- Received or plans to receive experimental drugs/vaccines within 30 days prior to, and
for the duration of the study.
- Received or plans to receive systemic immunosuppressive therapy, radiation therapy,
or high-dose inhaled steroids within 30 days of study vaccination.
- Use of systemic chemotheraphy 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.