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Anthrax clinical trials

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NCT ID: NCT01491607 Completed - Anthrax Clinical Trials

Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults

Start date: November 2011
Phase: Phase 3
Study type: Interventional

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. Results of this study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax. This study will be conducted in the United States (U.S.), in 200 healthy male and female volunteer subjects ages 18 to 65 years. The duration of study participation for each individual subject will be approximately 128 days (4.25 months), including a screening period of approximately 28 days followed by 100 days on study.

NCT ID: NCT01453907 Completed - Anthrax Clinical Trials

Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204. This study will be randomized, double-blind and stratified by gender. Each cohort will contain 36 subjects (including at least four females), 30 who will receive ETI-204 and six who will receive placebo.

NCT ID: NCT01265745 Completed - Anthrax Clinical Trials

Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects

Start date: December 2010
Phase: Phase 1
Study type: Interventional

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). Valortim is a monoclonal antibody (laboratory-made immune system molecule) for the treatment of inhalation anthrax (when the infection starts in the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the toxin from doing damage to cells. This study is being conducted to see if Valortim given over 120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase, Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the time when you receive the study medication), Follow-up Phase (the time after you receive the study medication) and Final Visit.

NCT ID: NCT01263691 Completed - Clinical trials for Bacillus Anthracis (Anthrax) Infection

Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

Start date: December 2010
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

NCT ID: NCT01202695 Completed - Anthrax Clinical Trials

Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)

Start date: August 2010
Phase: Phase 1
Study type: Interventional

Primary: • To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: - To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 - To evaluate the immunogenicity of AVP-21D9

NCT ID: NCT00964834 Terminated - Anthrax Clinical Trials

Ph1 Study of Valortim and Doxycycline in Humans

Start date: July 2009
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00964561 Suspended - Anthrax Clinical Trials

Ph1 Study of Valortim and Ciprofloxacin in Humans

Start date: August 2009
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00845650 Completed - Anthrax Clinical Trials

Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

Start date: February 2009
Phase: Phase 1/Phase 2
Study type: Interventional

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 mg/kg total IgG, GAMUNEX® (immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark of Talecris Biotherapeutics. - evaluate the pharmacokinetic (PK) 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 measured by lethal toxin neutralizing antibody (TNA).

NCT ID: NCT00448253 Completed - Clinical trials for Symptoms of Inhalational Anthrax

Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum

Start date: July 2007
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.

NCT ID: NCT00170469 Completed - Clinical trials for Bacillus Anthracis (Anthrax)

Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed

Start date: March 2005
Phase: Phase 2
Study type: Interventional

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.