trial of rpa-102 vaccine in healthy adult volunteers

Conditions: Anthrax

Summary: the purpose of this study is to assess the safety and immunogenicity of rpa102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.


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 18-55 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. 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, 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 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 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.

Keywords: anthrax rpa102 vaccine