Clinical trials: Anthrax
Inhalational Anthrax
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event.
- Trial name
- NCT03569553
- Testing
- AIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Anthrax
Ph1 Study of Valortim and Doxycycline in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV doxycycline when administered concomitantly with IV Valortim in normal healthy human subjects.
- Trial name
- NCT00964834
- Testing
- Doxycycline and Valortim
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
Bacillus Anthracis (Anthrax)
Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an immune response will be evaluated.
- Trial name
- NCT00170469
- Testing
- AVA, rPA vaccine containing alhydrogel
- Where
- 16 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited
Ischemic Stroke
Glyburide Advantage in Malignant Edema and Stroke Pilot
The primary objective of this study is to assess the feasibility of enrolling, evaluating, and treating with glyburide for injection severe anterior circulation ischemic stroke participants, whether or not treated with standard…
- Trial name
- GAMES-PILOT (NCT01268683)
- Testing
- Glyburide for Injection
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Remedy Pharmaceuticals, Inc.
Anthrax
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent…
- Trial name
- NCT07268612
- Testing
- CYFENDUS
- Volunteers
- 250 people
- Sponsor
- Emergent BioSolutions
Anthrax
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax.
- Trial name
- NCT01491607
- Testing
- BioThrax
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Anthrax
Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
This study is intended to estimate the Anthrax LF Dx System specificity. Sensitivity will be estimated with 10% of the samples spiked with recombinant Bacillus anthracis lethal factor (LF) used to prepare contrived positive…
- Trial name
- NCT05672875
- Testing
- Anthrax LF Dx System
- Where
- 3 sites in United States
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- SRI International
Anthrax Infection
A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines
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.
- Trial name
- NCT01979406
- Testing
- AVA, Ad4-PA-1, Ad4-PA-GPI-1
- Where
- 4 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Infection
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections…
- Trial name
- NCT01670435
- Testing
- Ciprofloxacin (BAYQ3939)
- Where
- Japan
- Volunteers
- 3,274 people
- Sponsor
- Bayer
Healthy Volunteers
NasoShield in Healthy Adults to Study Safety and Immunogenicity
The purpose of this study is to evaluate the safety for up to two doses of NasoShield, to determine if antibodies that protect against anthrax are formed after treatment with NasoShield, and to determine whether the formation of…
- Trial name
- NCT04415749
- Testing
- NasoShield
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
Therapeutic Treatment of Inhalation Anthrax
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
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…
- Trial name
- NCT02016963
- Testing
- Raxibacumab
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Human Genome Sciences Inc.
Infections, Bacterial
Clinical Benefit and Safety of Raxibacumab in Patients With Symptomatic Inhalational Anthrax in a Mass Exposure Scenario
This field study is designed such that it may be implemented for any individual with symptomatic inhalational anthrax who has been administered raxibacumab for treatment of anthrax following a mass exposure scenario.
- Trial name
- NCT02177721
- Testing
- Sample Collection
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Anthrax
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
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.
- Trial name
- NCT01770743
- Testing
- AV7909, BioThrax
- Where
- 4 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Anthrax
Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with systemic anthrax. The study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and…
- Trial name
- NCT03569514
- Testing
- AIGIV
- Volunteers
- 10 people
- Sponsor
- Emergent BioSolutions
Anthrax
Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study
This study is designed to evaluate the pharmacokinetic (PK) profiles of ciprofloxacin or doxycycline when administered orally, prior to, and following, the intramuscular (IM) administration of a two-dose schedule of AV7909…
- Trial name
- NCT04067011
- Testing
- Ciprofloxacin 500Mg Tablet, Doxycycline 100Mg Tablet, AV7909
- Where
- 4 sites in United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Anthrax
A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109
The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.
- Trial name
- GC1109 (NCT01624532)
- Where
- South Korea
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Anthrax
Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
Valortim is the name of the experimental drug that volunteers will receive in this study. Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by the Food and Drug Administration (FDA).
- Trial name
- NCT01265745
- Testing
- Normal Saline for Injection, MDX1303
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
Anthrax
PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine
The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel
- Trial name
- NCT02239172
- Testing
- PA83-FhCMB
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Healthy Volunteers
NasoShield Study of Safety and Immunogenicity
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
- Trial name
- NasoShield (NCT03352466)
- Testing
- NasoShield, BioThrax
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
Anthrax
Trial of rPA-102 Vaccine in Healthy Adult Volunteers
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.
- Trial name
- NCT00100724
- Testing
- rPA102
- Where
- 12 sites in United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- VaxGen