Clinical trials: Anthrax
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
Smallpox, Anthrax
VHA Clinicians and Bioterror Events: Interactive Web-based Learning
Our 4-year project uses public domain software and content developed by a University of Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician populations and electronic educational…
- Trial name
- NCT00123396
- Testing
- BioCASES and BioTESTS
- Where
- 9 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Bacillus Anthracis (Anthrax)
Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
A Phase IV, randomized, multicenter trial to assess the immunogenicity and safety of BioThrax® in varying dose regimens with the primary objective of obtaining information on possible dose-sparing strategies in the event of a…
- Trial name
- NCT01641991
- Testing
- BioThrax®
- Where
- 4 sites in United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Efficacy and Safety of Anthrax Vaccine, GC1109
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.
- Trial name
- NCT01867957
- Testing
- Low-dose GC1109, High-dose GC1109
- Where
- South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Infection
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily…
- Trial name
- NCT01690559
- Testing
- Cipro (Ciprofloxacin, BAYQ3939)
- Where
- Japan
- Volunteers
- 704 people
- Sponsor
- Bayer
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
Anthrax
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at…
- Trial name
- NCT00057525
- Testing
- Anthrax, Alhdryogel or PBS
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Anthrax
Anthrax-rPA: Safety, Tolerability, Immunogenicity
The primary objective is to determine the tolerability and safety, from days 0 to 210, of escalating doses of rPA either with or without Alhydrogel (an adjuvant; used to increase the action of the principle drug) given in a…
- Trial name
- NCT00063843
- Testing
- Recombinant Protective Antigen, Anthrax Vaccine Adsorbed
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacillus Anthracis (Anthrax)
UMD rPA Regimen Trial in Adults
Objectives are: To confirm the safety and tolerability of 2-dose regimens of 100 g rPA vaccines (3 products) administered by the intramuscular (IM) route to healthy adults.To describe the immunologic responses to 2-dose regimens…
- Trial name
- NCT00133484
- Testing
- Anthrax vaccine absorbed made from Bacillus anthracis (AVA), Recombinant protein antigen (rPA) made from Bacillus anthrax, Recombinant protein antigen (rPA) made from Escherichia coli
- Where
- 2 sites in United States
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacillus Anthracis (Anthrax)
Monoclonal Antibody for Treatment of Inhalation Anthrax
The purpose of this study is to evaluate the safety and pharmacokinetics (how long a drug stays in the bloodstream and how high the levels of the drug are at different times) of ETI-204 following intravenous (IV-into a vein)…
- Trial name
- NCT00138411
- Testing
- Ciprofloxacin 500 mg, ETI-204 (Anthim)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Anthrax
Ph1 Study of Valortim and Ciprofloxacin in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.
- Trial name
- NCT00964561
- Testing
- Ciprofloxacin and Valortim
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
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.
Prevention of Bacillus Anthracis (Anthrax) Infection
Phase II Study of Range and Schedule of rPA Doses
This is a dose ranging study comparing different vaccine schedules of rPA vaccine for anthrax. Safety and the capability to induce an immune response will be evaluated.
- Trial name
- NCT00170456
- Testing
- rPA vaccine containing alhydrogel
- Where
- 2 sites in United Kingdom
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited
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
Anthrax
Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases.
- Trial name
- NCT00031291
- Testing
- Anthrax Immune Globulin
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
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
Prevention of Anthrax Infection
Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
- Trial name
- NCT00103467
- Testing
- rPA102 Vaccine
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- VaxGen