AnthraxPhase 2NCT01770743
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
A Phase 2 study testing AV7909 and BioThrax in people with Anthrax, run by Emergent BioSolutions at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- AV7909 and BioThrax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Dec 2014
- Phase
- Phase 2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18-50 years old
- Be in good health
- Have access to a computer and the internet so you can complete a diary
- Agree to abstain from sex the first 84 days of the study or practice birth control if you are a woman who is able to get pregnant
- Have not donated blood for the previous 8 weeks
Who cannot join
- A known anaphylactic response, severe systemic response, or serious hypersensitivity reaction to a prior immunization.
- A history of latex allergy.
- Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to get a shot for 4 weeks after the last study shot is given.
- Have previously served in the military any time after 1990 or plan to enlist in the military from Screening through Day 84.
- Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine, or known exposure to anthrax organisms.
- Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or anthrax immune globulins or anthrax vaccines).
Show all 18Show fewer
- Participation in any investigational study involving use of a pharmacological intervention within 30 days before the Screening visit or planning to participate in a study requiring dosing through the 12-month safety follow-up telephone call.
- Have a known diagnosis of any immunodeficiency disease including but not limited to: acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease, immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia.
- Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis in the area of vaccinations, or requires immunotherapy, glomerulonephritis, or autoimmune thyroiditis.
- Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the past 2 years.
- A history of cytotoxic chemotherapy or radiation therapy.
- Chronic (>10 days) daily oral or parenteral corticosteroid therapy in the past 12 months.
- Any lung disease, including reactive airway disease, which requires the daily use of medications.
- A female currently breastfeeding or with a positive pregnancy test.
- A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines, benzodiazepines, or oxycodone.
- Any tattoo or other skin condition in the deltoid region on either arm that may obscure the assessment of the injection sites.
- A medical condition that, in the opinion of the PI or designee, could adversely impact the subject's participation or safety or the conduct of the study.
- Any planned elective in-patient surgery during the study period.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Miami Research Associates
Miami, Florida, 33143
Costal Carolina Research
Mt. Pleasant, South Carolina, 29464
Central Texas Allergy and Asthma
New Braunfels, Texas, 78130
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax Using Three Immunization Schedules and Two Dose Levels in Healthy Adult Volunteers
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.
Read the detailed description
The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.
- Conditions
- Anthrax
- Being tested
- AV7909, 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.
AV7909Biological
Also called AV7909 Anthrax Vaccine, NuThrax
Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
BioThraxBiological
Also called Anthrax Vaccine Adsorbed (AVA)
| Study group | Role | What they receive |
|---|---|---|
| AV7909 (Day 0 and 14) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 Receives: Biological: AV7909 |
| AV7909 (Day 0 and 28) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 Receives: Biological: AV7909 |
| AV7909 (Day 0, 14, and 28) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 Receives: Biological: AV7909 |
| AV7909 Reduced Dose | Experimental | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 Receives: Biological: AV7909 |
| BioThrax | Active comparator | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 Receives: Biological: BioThrax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxin Neutralizing Antibody (TNA) Level at Day 63
Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold
Measured: Day 63
Incidence of Adverse Events
Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84
Measured: From the time of the first immunization on Day 0 through Day 84
Incidence of Serious Adverse Events
Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Measured: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Incidence of Reactogenicity By Severity
Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.
Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):
Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.
For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity.
Measured: For 7 days following each vaccination on Days 0, 14, 28
Incidence of Clinical Laborabory Abnormalities
Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).
Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality.
Measured: From the time of first immunization on Day 0 to Day 84
Incidence of Immunologically Significant Adverse Events of Special Interest
Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Measured: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Secondary outcomes (3)
TNA Level at Day 42
Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold
Measured: Day 42
TNA Level at Day 28
Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold
Measured: Day 28
TNA Seroconversion Rate
Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84
Measured: Up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionDec 2014
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurdyal Kalsi, MD, MTOPRA, Principal investigator, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770743
- Sponsor's protocol ID
- EBS.AVA.208 / DMID 11-0055
- Other IDs
- HHSN272201000035C
- Status last verified
- Mar 2024
- First submitted
- 16 Jan 2013
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax Using Three Immunization Schedules and Two Dose Levels in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01770743
- Acronym / sponsor ID
- EBS.AVA.208 / DMID 11-0055
- Conditions
- Anthrax
- Keywords
- post-exposure prophylaxis, toxin neutralization assay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 24 Feb 2015
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 study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.
Detailed description
The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AV7909 (Day 0 and 14) | Experimental | Biological: AV7909Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 |
| AV7909 (Day 0 and 28) | Experimental | Biological: AV7909Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 |
| AV7909 (Day 0, 14, and 28) | Experimental | Biological: AV7909Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 |
| AV7909 Reduced Dose | Experimental | Biological: AV7909Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 |
| BioThrax | Active comparator | Biological: BioThraxRoute of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be 18-50 years old
- Be in good health
- Have access to a computer and the internet so you can complete a diary
- Agree to abstain from sex the first 84 days of the study or practice birth control if you are a woman who is able to get pregnant
- Have not donated blood for the previous 8 weeks
Key exclusion criteria (18 listed)
- A known anaphylactic response, severe systemic response, or serious hypersensitivity reaction to a prior immunization.
- A history of latex allergy.
- Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to get a shot for 4 weeks after the last study shot is given.
- Have previously served in the military any time after 1990 or plan to enlist in the military from Screening through Day 84.
- Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine, or known exposure to anthrax organisms.
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 |
|---|---|---|
| AV7909Also: AV7909 Anthrax Vaccine, NuThraxAnthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | Biological | AV7909 (Day 0 and 14), AV7909 (Day 0 and 28), AV7909 (Day 0, 14, and 28), AV7909 Reduced Dose |
| BioThraxAlso: Anthrax Vaccine Adsorbed (AVA) | Biological | BioThrax |
Primary outcome
Toxin Neutralizing Antibody (TNA) Level at Day 63
Time frame: Day 63
Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold
Incidence of Adverse Events
Time frame: From the time of the first immunization on Day 0 through Day 84
Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84
Incidence of Serious Adverse Events
Time frame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Incidence of Reactogenicity By Severity
Time frame: For 7 days following each vaccination on Days 0, 14, 28
Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity.
Incidence of Clinical Laborabory Abnormalities
Time frame: From the time of first immunization on Day 0 to Day 84
Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality.
Incidence of Immunologically Significant Adverse Events of Special Interest
Time frame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
3 secondary outcomes
TNA Level at Day 42
Time frame: Day 42
TNA Level at Day 28
Time frame: Day 28
TNA Seroconversion Rate
Time frame: Up to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Gurdyal Kalsi, MD, MTOPRA principal investigator
Emergent BioSolutions
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV7909 and 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 5 inclusion and 18 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 18 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Feb 2015). 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?
Toxin Neutralizing Antibody (TNA) Level at Day 63 (time frame: Day 63). The study lists 6 primary outcomes in all. 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 18 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.