Phase 2 N=305 BARDA Securing Anthrax Immunity For the Elderly
Anthrax
Primary: Solicited Local Reactogenicity Symptoms — 46; 43; 40; 45 Participants
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Phase 3 N=200 Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Anthrax
Primary: Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). — 71.2; 68.5; 73.9; 76.7…
Phase 1 N=41 Anthrax AV7909 Liquid vs Lyophilized
Anthrax · Anthrax Immunisation
Primary: Number of Participants With Serious Adverse Events (SAEs). — 0; 0 Participants
Phase 4 N=1,564 Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Healthy
Primary: Local AEs — 500; 344; 186; 189 injections
Phase 3 N=3,689 VELOCITY: An Anthrax Vaccine Clinical Study
Anthrax
Primary: Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64 — 0.765; 0.741; 0.716; 0.330 Titer (TNA NF50)
Phase 3 N=20 An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
Therapeutic Treatment of Inhalation Anthrax
Primary: Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response — 0 Participants
Phase 1 N=105 Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Bacillus Anthracis (Anthrax) Infection
Primary: Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) — 11; 17; 13…
N/A N=6 The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores
COVID-19 Pneumonia
Primary: Serum Neutralizing Receptor Binding Domain IgG Antibody Concentration — 0.2; 9.3; 35.8 ug/ml
N/A N=83 Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Healthy
Primary: Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress — 0.5; 0.3; 0.6; 0.7 units on a scale
Phase 2 N=168 A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Anthrax
Primary: Toxin Neutralizing Antibody (TNA) Level at Day 63 — 56.8; 100; 100; 90.2 percentage of participants
N/A N=262 Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
Osteomyelitis
Primary: Description of the Clinical and Epidemiological Profile of Patients With Infection — 92; 26; 25; 21 Participants
Phase 2 N=154 Ciprofloxacin BioThrax Co-Administration Study
Anthrax
Primary: Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44) — 0.944; 0.887 ratio
Phase 4 N=573 Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
Infections, Bacterial
Primary: Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose)…
Phase 2 N=129 Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
Anthrax
Primary: Number of Participants Reporting Adverse Events (AEs) — 28; 5; 29; 11 Participants
Phase 4 N=328 Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
Bacillus Anthracis (Anthrax)
Primary: Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody…
Phase 4 N=22 Special Access Program IMVAMUNE®
Vaccination
Primary: ELISA Seropositivity Rate — 40.9; 100.0 percentage of subjects