Clinical trials: Anthrax
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
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 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 Human Monoclonal Antibody (AVP-21D9)
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…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 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
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
Study is Being Conducted in Healthy Volunteers
A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers
This study will be conducted to establish the relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with and without a spacer device.
- Trial name
- NCT02934607
- Testing
- Symbicort pMDI with spacer device, Symbicort pMDI without spacer device
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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
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
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
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
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
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
Healthy Volunteers
NasoShield Study of Safety and Immunogenicity
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of NasoShield in healthy adults 18 to 49 years of age.
- Trial name
- NasoShield (NCT03352466)
- Testing
- NasoShield, BioThrax
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
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
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
Symptoms of Inhalational Anthrax
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
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.
- Trial name
- NCT00448253
- Testing
- NP-015
- Where
- United States
- Volunteers
- 92 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.
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.
Anthrax
A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109
The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.
- Trial name
- GC1109 (NCT01624532)
- Where
- South Korea
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation