Clinical trials: Anthrax
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
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
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.
Inhalational Anthrax
Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
This study is to evaluate the safety, local tolerability, pharmacokinetics (PK) and immunogenicity of escalating single intramuscular (IM) doses of ETI-204 in healthy volunteers
- Trial name
- NCT01932437
- Testing
- ETI-204
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
Anthrax
BARDA Securing Anthrax Immunity For the Elderly
This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable…
- Trial name
- B-SAFE (NCT03518125)
- Testing
- BioThrax, AV7909
- Where
- 4 sites in United States
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- Biomedical Advanced Research and Development Authority
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
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, Anthrax Immunisation
Anthrax AV7909 Liquid vs Lyophilized
This is a randomized, parallel-group, double-blind, Phase 1 study designed to assess safety, tolerability and immunogenicity 2 formulations of adjuvanted anthrax vaccine (AV7909), lyophilized and liquid.
- Trial name
- NCT04660201
- Testing
- AV7909
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change
Anthrax Clinical Trial Objectives: To assess whether: Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e.…
- Trial name
- AVRP (NCT00119067)
- Testing
- Anthrax Vaccine Adsorbed, Saline injection
- Where
- 5 sites in United States
- Volunteers
- 1,564 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
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
Healthy Adult Volunteers
A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers
This is a pilot study designed to test feasibility, tolerability, and safety of medical grade oral Activated Charcoal (AC) in 12 healthy volunteers. To determine the two most palatable and tolerable AC combinations.
- Trial name
- NCT04204772
- Testing
- Activated charcoal and Tap Water, Activated Charcoal and Apple Juice
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
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)
Inhalational Anthrax
Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
Evaluate the safety, tolerability and pharmacokinetics (PK) of intravenous (IV) ETI-204 alone and in the presence of IV and oral ciprofloxacin
- Trial name
- NCT01952444
- Testing
- ETI-204, Ciprofloxacin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
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
Malaria, Severe Malaria
Evaluation of Oral Activated Charcoal on Antimalarial Drug's Ability to Kill Parasites in Malian Children With Malaria
Background: Malaria is caused by small parasites carried by some mosquitoes. People can get malaria if an infected mosquito bites them. Malaria destroys red blood cells.
- Trial name
- NCT01955382
- Testing
- Actidose Aqua, Artesunate, Amodiaquine
- Where
- Mali
- Volunteers
- 70 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bacillus Anthracis (Anthrax) Infection
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults.
- Trial name
- NCT01263691
- Testing
- BioThrax, AV7909 Formulation 1, AV7909 Formulation 2
- Where
- 3 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
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
Anthrax
VELOCITY: An Anthrax Vaccine Clinical Study
This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to…
- Trial name
- NCT03877926
- Testing
- AV7909, BioThrax
- Where
- 35 sites in United States
- Volunteers
- 3,689 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions