Clinical trials: Anthrax
Healthy Volunteers
Foster With or Without Charcoal Block or Aerochamber Plus
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the…
- Trial name
- NCT01280175
- Testing
- charcoal block, Aerochamber Plus spacer, pMDI standard actuator
- Where
- Switzerland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
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
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
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
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
Ciprofloxacin BioThrax Co-Administration Study
The purpose of this clinical trial is to determine whether there is any effect on the antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of BioThrax® (Anthrax Vaccine Adsorbed or AVA).
- Trial name
- NCT01753115
- Testing
- BioThrax, Ciprofloxacin
- Where
- 3 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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.
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
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 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
Pregnancy Complications, Pregnancy Outcome
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
- Conditions
- Pregnancy Complications, Pregnancy Outcome, Congenital Abnormalities
- Trial name
- NCT01653392
- Testing
- Observational Intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
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
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
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
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
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
Infections, Bacterial
Observational Study of Raxibacumab in Sporadic Cases of Systemic Anthrax
This observational, open-label, single arm, study is designed such that it may be implemented for any individual with a lab confirmed sporadic case of systemic anthrax disease treated with raxibacumab outside of the current…
- Trial name
- NCT07478471
- Testing
- Collection of samples
- Volunteers
- 10 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.