View clinical trials related to Anthrax.
Filter by:This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
This is an open-label study to evaluate the immunogenicity and safety of raxibacumab in healthy adult male and female subjects. Subjects who have received raxibacumab >= 4 months ago will be enrolled and dosed as follows: A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose >= 4 months following the first dose. Subjects will remain in house from Day 0 until Day 1 and will be followed for 70 days after receiving the second dose of raxibacumab. Raxibacumab has been shown to provide improved survival in rabbit and monkey anthrax spore challenge studies. Preliminary data from our rabbit pivotal efficacy study showed significant survival benefit for raxibacumab over placebo. Exposure to anthrax and resulting clinical disease can occur more than once, especially in individuals who do not develop protective immunity. Hence, if clinically indicated for the treatment of anthrax, there may be a requirement for the repeat administration of raxibacumab. The rationale of the study is to evaluate the immunogenicity and safety of repeat administration of raxibacumab with a >= 4 month interval between dosing.
The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.
Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.
To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.
1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies. 2. OBJECTIVE - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers. 3. STUDY DESIGN - single-blinded - randomized - placebo controlled - phase 1 study
This is a randomized, multi-center, prospective, double blind study. The primary objective is to assess the efficacy and safety of glyburide (RP-1127) compared to placebo in participants with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.This objective will be addressed by comparing the proportion of glyburide treated particpants and placebo treated participants with a Day 90 modified Rankin Scale (mRS) ≤ 4 without decompressive craniectomy (DC). The secondary objective is to assess the efficacy of RP-1127 compared to placebo in participants with a severe anterior circulation ischemic stroke who were likely to develop malignant edema.
The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.