Clinical trials: Anthrax
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
Healthy Participants
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05320094
- Testing
- Mavacamten, Activated Charcoal with Sorbitol
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Inhalational Anthrax
Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers
To evaluate the safety, tolerability, pharmacokinetics and immunogenicity of repeat administration (two doses) of intravenous (IV) ETI-204.
- Trial name
- NCT01932242
- Testing
- ETI-204
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
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
Healthy
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics.
Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning.
- Trial name
- RICHAR2 (NCT04767776)
- Testing
- Rivaroxaban, Activated charcoal
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Anthrax
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
The purpose of this study is to: evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360…
- Trial name
- NCT00845650
- Testing
- AIGIV 3.5 mg/kg, Gamunex 90 mg/kg, AIGIV 7.0 mg/kg
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
Anthrax
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010. BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to…
- Trial name
- IN NE-rPA (NCT04148118)
- Testing
- BW-1010: 50 µg - sprayer - IN, BW-1010: 50 µg - pipette - IN, BW-1010: 100 µg - sprayer - IN
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
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
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.
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
Anthrax
Anthrax AV7909 Boost Evaluation Study
This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and…
- Trial name
- ABESt (NCT05997264)
- Testing
- AV7909 Full Dose (0.5 mL), AV7909 Half Dose (0.25 mL)
- Where
- 7 sites in United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
Anthrax
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
- Trial name
- NCT02655549
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Pfenex, Inc
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
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.
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.
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.
Inhalational Anthrax
Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.
- Trial name
- NCT01929226
- Testing
- ETI-204
- Where
- United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
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
Infections, Bacterial
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
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.
- Trial name
- NCT02339155
- Testing
- AVA, Raxibacumab, Diphenhydramine
- Where
- 3 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions