AnthraxPhase 3NCT01491607
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
A Phase 3 study testing BioThrax in people with Anthrax, run by Emergent BioSolutions at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- BioThrax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to May 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Miami Research Associates
Miami, Florida, 33143
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Rochester Clinical Research
Rochester, New York, 14609
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
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.
Read the 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.
- Conditions
- Anthrax
- Being tested
- BioThrax
- Keywords
- post-exposure prophylaxis, toxin neutralization assay
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioThraxBiological
Also called Anthrax Vaccine Adsorbed (AVA)
BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
| Study group | Role | What they receive |
|---|---|---|
| BioThrax (0.5 mL, on days 0, 14, and 28) | Experimental | Not described Receives: Biological: BioThrax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 63 +/- 2 days
Secondary outcomes (6)
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.
Measured: Day 70 +/- 2 days
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.
Measured: Days 63 to 100
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.
Measured: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
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.
Measured: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
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.
Measured: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
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.
Measured: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Robert Hopkins, MD, MPH, TM, Principal investigator, Emergent BioSolutions Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491607
- Sponsor's protocol ID
- EBS.AVA.006
- Other IDs
- HHSO100200700037C
- Status last verified
- Mar 2024
- First submitted
- 12 Dec 2011
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
- ClinicalTrials.gov ID
- NCT01491607
- Acronym / sponsor ID
- EBS.AVA.006
- Conditions
- Anthrax
- Keywords
- post-exposure prophylaxis, toxin neutralization assay
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Posted 28 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioThrax (0.5 mL, on days 0, 14, and 28) | Experimental | Biological: BioThrax |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioThraxAlso: Anthrax Vaccine Adsorbed (AVA)BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28. | Biological | BioThrax (0.5 mL, on days 0, 14, and 28) |
Primary outcome
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).
Time frame: Day 63 +/- 2 days
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.
6 secondary outcomes
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.
Time frame: Day 70 +/- 2 days
Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).
Time frame: Days 63 to 100
Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Time frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Time frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Time frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards
Time frame: Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hopkins, MD, MPH, TM principal investigator
Emergent BioSolutions Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BioThrax in people with Anthrax, run by Emergent BioSolutions at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28). (time frame: Day 63 +/- 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.