PH I/II PROOF OF CONCEPT TRIAL OF ANTHRAX VACCINE COMBINED WITH CPG 7909

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: The objectives are to explore the characteristics and kinetics of the human immune system response as well as the safety profile of the combination of Anthrax Vaccine Adsorbed (AVA) with CpG 7909 when given as three intramuscular injections (i.m.) with each injection given two weeks apart. RESEARCH PLAN: This study will be a proof-of-concept, double-blind, randomized, controlled trial comparing AVA combined with CpG to AVA alone or CpG 7909 injection alone. METHODS: Approximately 75 normal volunteers will be randomized equally to one of the three groups (25 per group). Males and females will be separately randomized. Participants will be given three i.m. injections of investigational agents at study weeks 0, 2, and 4. Blood will be collected at screening and at various time points throughout the study period to assess immunological outcome measures. Blood and urine will be collected at screening and study end to assess safety parameters (blood chemistry and hematology, infectious diseases serology, autoimmune disease markers, and urinalysis). Adverse events will be assessed at each clinic visit. CLINICAL RELEVANCE: It is the intent of this clinical trial to take steps in addressing how to accelerate the protective immune response against anthrax. The scheduled six month safety follow-up questionnaire was completed by 7 subjects from the 2004 randomization group by 3/31/05. No new medical problems or other adverse events were reported by these 7 subjects. No serious adverse events have been noted for all subjects through 3/31/05. Total enrollment for the study at both sites is 135 subjects, 66 were excluded, and 69 were randomized to receive study injections.