Back to resultsImmunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Primary Purpose
Anthrax
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BioThrax
Sponsored by
About this trial
This is an interventional treatment trial for Anthrax focused on measuring post-exposure prophylaxis, toxin neutralization assay
Eligibility Criteria
Inclusion Criteria:
- Be between 18 and 65 years of age, inclusive, at the time of enrollment.
- Be in good health as determined by the investigator from medical history and a physical examination.
- If a pre-menopausal female, must be using acceptable methods of birth control.
- Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
- Be willing and able to return for all visits and blood collections for the duration of the study.
- Have read, understood and signed an informed consent form.
Exclusion Criteria:
- Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
- Intend to enlist in the military during the study.
- Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
- Plan to receive experimental products at any time during the study.
- Have received a live vaccine in the 30 days before study entry.
- Plan to receive a live vaccine at any time during the study.
- Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
- Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
- Have a condition known to produce or be associated with immunosuppression.
- Have received cytotoxic therapy in the previous 5 years.
- A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Sites / Locations
- Miami Research Associates
- Rochester Clinical Research
- Coastal Carolina Research Center
- Jean Brown Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BioThrax (0.5 mL, on days 0, 14, and 28)
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Secondary Outcome Measures
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Full Information
NCT ID
NCT01491607
First Posted
December 12, 2011
Last Updated
September 25, 2013
Sponsor
Emergent BioSolutions
Collaborators
Department of Health and Human Services
1. Study Identification
Unique Protocol Identification Number
NCT01491607
Brief Title
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Official Title
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions
Collaborators
Department of Health and Human Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a post-exposure vaccination schedule. Correlations will be drawn to immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit a protective immune response for PEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
Keywords
post-exposure prophylaxis, toxin neutralization assay
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioThrax (0.5 mL, on days 0, 14, and 28)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BioThrax
Other Intervention Name(s)
Anthrax Vaccine Adsorbed (AVA)
Intervention Description
BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Primary Outcome Measure Information:
Title
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
Description
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame
Day 63 +/- 2 days
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
Description
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame
Day 70 +/- 2 days
Title
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
Description
Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.
Time Frame
Days 63 to 100
Title
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description
Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame
Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Title
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description
Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame
Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Title
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description
Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame
Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Title
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Description
Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.
Time Frame
Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be between 18 and 65 years of age, inclusive, at the time of enrollment.
Be in good health as determined by the investigator from medical history and a physical examination.
If a pre-menopausal female, must be using acceptable methods of birth control.
Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
Be willing and able to return for all visits and blood collections for the duration of the study.
Have read, understood and signed an informed consent form.
Exclusion Criteria:
Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
Intend to enlist in the military during the study.
Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
Plan to receive experimental products at any time during the study.
Have received a live vaccine in the 30 days before study entry.
Plan to receive a live vaccine at any time during the study.
Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
Have a condition known to produce or be associated with immunosuppression.
Have received cytotoxic therapy in the previous 5 years.
A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hopkins, MD, MPH, TM
Organizational Affiliation
Emergent BioSolutions Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Rochester Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
We'll reach out to this number within 24 hrs