Anthrax
Conditions
Keywords
post-exposure prophylaxis, toxin neutralization assay
Brief 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.
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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Immunologically Significant Adverse Events of Special Interest | 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 |
| 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 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 | 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 | 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. |
| Toxin Neutralizing Antibody (TNA) Level at Day 63 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TNA Level at Day 28 | Day 28 | Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold |
| TNA Seroconversion Rate | Up to Day 84 | 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 |
| TNA Level at Day 42 | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 16 January 2013 to 14 November 2013 at 4 medical centers in the United States.
Pre-assignment details
All 168 enrolled participants who met eligibility criteria were dosed.
Participants by arm
| Arm | Count |
|---|---|
| AV7909 (Day 0 and 14) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 44 |
| AV7909 (Day 0 and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 34 |
| AV7909 (Day 0, 14, and 28) Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 23 |
| AV7909 Reduced Dose Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 44 |
| BioThrax Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
BioThrax | 23 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 | 1 |
| Overall Study | Moving Out of State | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Sponsor Terminated Subject | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 164 Participants | 44 Participants | 32 Participants | 22 Participants | 44 Participants | 22 Participants |
| Age, Continuous | 32.5 years STANDARD_DEVIATION 9.5 | 33.4 years STANDARD_DEVIATION 9 | 32.7 years STANDARD_DEVIATION 9.7 | 29.7 years STANDARD_DEVIATION 10.2 | 32.8 years STANDARD_DEVIATION 9.2 | 32.5 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 9 Participants | 7 Participants | 4 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 139 Participants | 35 Participants | 27 Participants | 19 Participants | 39 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 154 Participants | 40 Participants | 33 Participants | 20 Participants | 40 Participants | 21 Participants |
| Region of Enrollment United States | 168 participants | 44 participants | 34 participants | 23 participants | 44 participants | 23 participants |
| Sex: Female, Male Female | 83 Participants | 22 Participants | 17 Participants | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 85 Participants | 22 Participants | 17 Participants | 12 Participants | 22 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 32 / 44 | 18 / 34 | 10 / 23 | 27 / 44 | 9 / 23 |
| serious Total, serious adverse events | 2 / 44 | 0 / 34 | 0 / 23 | 0 / 44 | 1 / 23 |
Outcome results
Primary
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
Time frame: From the time of the first immunization on Day 0 through Day 84
Population: Safety Population (subjects who received at least one dose of IMP)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AV7909 (Day 0 and 14) | Incidence of Adverse Events | 36 participants |
| AV7909 (Day 0 and 28) | Incidence of Adverse Events | 26 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Adverse Events | 17 participants |
| AV7909 Reduced Dose | Incidence of Adverse Events | 35 participants |
| BioThrax | Incidence of Adverse Events | 15 participants |
Primary
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.
Time frame: From the time of first immunization on Day 0 to Day 84
Population: Safety Population (subjects who received at least one dose of IMP)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Neutrophils | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Alanine Aminotransferase | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Leukocytes | 8 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Glucose | 9 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Urine Protein | 16 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Glucose Fasting | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Bilirubin | 1 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Blood Urea Nitrogen | 1 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Lymphocytes | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Hemoglobin | 39 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Aspartate Aminotransferase | 3 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Urine Glucose | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Clinical Laborabory Abnormalities | Urine Erythrocytes | 11 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Hemoglobin | 29 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Glucose | 1 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Alanine Aminotransferase | 3 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Blood Urea Nitrogen | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Protein | 10 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Erythrocytes | 5 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Glucose | 7 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Neutrophils | 1 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Leukocytes | 4 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Lymphocytes | 1 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Bilirubin | 2 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Glucose Fasting | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Clinical Laborabory Abnormalities | Aspartate Aminotransferase | 2 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Glucose Fasting | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Glucose | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Bilirubin | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Blood Urea Nitrogen | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Neutrophils | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Alanine Aminotransferase | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Hemoglobin | 20 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Lymphocytes | 4 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Erythrocytes | 4 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Aspartate Aminotransferase | 3 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Urine Protein | 5 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Glucose | 8 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Clinical Laborabory Abnormalities | Leukocytes | 3 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Aspartate Aminotransferase | 4 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Hemoglobin | 42 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Leukocytes | 3 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Neutrophils | 3 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Lymphocytes | 2 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Alanine Aminotransferase | 3 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Glucose | 13 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Glucose Fasting | 0 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Bilirubin | 0 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Blood Urea Nitrogen | 1 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Urine Glucose | 0 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Urine Protein | 13 participants |
| AV7909 Reduced Dose | Incidence of Clinical Laborabory Abnormalities | Urine Erythrocytes | 7 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Urine Glucose | 1 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Glucose | 2 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Alanine Aminotransferase | 2 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Aspartate Aminotransferase | 1 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Neutrophils | 0 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Urine Protein | 6 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Blood Urea Nitrogen | 0 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Hemoglobin | 19 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Lymphocytes | 0 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Leukocytes | 0 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Bilirubin | 1 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Glucose Fasting | 0 participants |
| BioThrax | Incidence of Clinical Laborabory Abnormalities | Urine Erythrocytes | 8 participants |
Primary
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
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
Population: Safety Population (subjects who received at least one dose of IMP)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AV7909 (Day 0 and 14) | Incidence of Immunologically Significant Adverse Events of Special Interest | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Immunologically Significant Adverse Events of Special Interest | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Immunologically Significant Adverse Events of Special Interest | 0 participants |
| AV7909 Reduced Dose | Incidence of Immunologically Significant Adverse Events of Special Interest | 0 participants |
| BioThrax | Incidence of Immunologically Significant Adverse Events of Special Interest | 0 participants |
Primary
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.
Time frame: For 7 days following each vaccination on Days 0, 14, 28
Population: Safety Population (subjects who received at least one dose of IMP)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Swelling Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Tenderness Grade 2 | 11 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Tenderness Grade 1 | 31 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Warmth Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Headache Grade 3 | 4 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Swelling Grade 2 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Warmth Grade 2 | 1 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Warmth Grade 1 | 17 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fever Grade 3 | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fever Grade 1 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 2 | 6 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fever Grade 2 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Redness Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Swelling Grade 1 | 12 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Lump Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Lump Grade 2 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 3 | 3 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Pain Grade 2 | 9 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Lump Grade 1 | 13 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Redness Grade 2 | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Redness Grade 1 | 6 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 1 | 25 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Bruise Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 3 | 1 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 2 | 11 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Bruise Grade 1 | 4 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 1 | 11 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 1 | 21 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 3 | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 2 | 6 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Pain Grade 3 | 1 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Pain Grade 1 | 30 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Itching Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Headache Grade 1 | 10 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Bruise Grade 2 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Itching Grade 2 | 2 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Itching Grade 1 | 5 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Tenderness Grade 3 | 0 participants |
| AV7909 (Day 0 and 14) | Incidence of Reactogenicity By Severity | Headache Grade 2 | 7 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Redness Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 2 | 6 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 1 | 17 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 2 | 5 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 1 | 19 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 1 | 6 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Headache Grade 1 | 15 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Headache Grade 2 | 3 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Headache Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fever Grade 1 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fever Grade 2 | 1 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Fever Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 1 | 15 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 2 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 1 | 27 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 2 | 6 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Itching Grade 1 | 3 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Itching Grade 2 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Itching Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Pain Grade 1 | 29 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Pain Grade 2 | 2 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Pain Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 1 | 15 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 2 | 9 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Redness Grade 1 | 5 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Redness Grade 2 | 1 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Lump Grade 1 | 6 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Lump Grade 2 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Lump Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 1 | 7 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 2 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 3 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 2 | 0 participants |
| AV7909 (Day 0 and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Lump Grade 2 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Pain Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 2 | 5 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 1 | 2 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 1 | 14 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 1 | 11 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Itching Grade 1 | 3 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Lump Grade 1 | 9 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 1 | 17 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 2 | 7 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 2 | 7 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 1 | 11 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 3 | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 1 | 13 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Bruise Grade 2 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Headache Grade 1 | 9 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Redness Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Redness Grade 2 | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Redness Grade 1 | 3 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Itching Grade 2 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 2 | 2 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fever Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fever Grade 2 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Pain Grade 1 | 15 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Itching Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Warmth Grade 3 | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fever Grade 1 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Tenderness Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 1 | 7 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Headache Grade 2 | 6 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 2 | 1 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Headache Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Pain Grade 2 | 7 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Swelling Grade 2 | 2 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Lump Grade 3 | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Reactogenicity By Severity | Muscle Ache Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Headache Grade 2 | 7 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Swelling Grade 2 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Tenderness Grade 1 | 29 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Tenderness Grade 2 | 9 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 1 | 19 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Tenderness Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Headache Grade 1 | 14 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Muscle Ache Grade 2 | 9 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Itching Grade 1 | 10 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Itching Grade 2 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Swelling Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Itching Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Muscle Ache Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Pain Grade 1 | 29 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Bruise Grade 1 | 8 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Pain Grade 2 | 8 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Pain Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 1 | 17 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Muscle Ache Grade 1 | 27 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 2 | 11 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Bruise Grade 2 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Redness Grade 1 | 10 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Redness Grade 2 | 1 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Redness Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Lump Grade 1 | 16 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Lump Grade 2 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 2 | 2 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Bruise Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Lump Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fever Grade 1 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Swelling Grade 1 | 14 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fever Grade 2 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Fever Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Headache Grade 3 | 0 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Warmth Grade 1 | 14 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Warmth Grade 2 | 2 participants |
| AV7909 Reduced Dose | Incidence of Reactogenicity By Severity | Warmth Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Pain Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Bruise Grade 1 | 4 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Tenderness Grade 1 | 14 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Lump Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Warmth Grade 1 | 11 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Tenderness Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Pain Grade 2 | 6 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Headache Grade 1 | 8 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Lump Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Pain Grade 1 | 14 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Bruise Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Swelling Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Tenderness Grade 2 | 5 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fever Grade 1 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Itching Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Warmth Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Muscle Ache Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Warmth Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fever Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Headache Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Swelling Grade 1 | 7 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Itching Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Headache Grade 2 | 1 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Redness Grade 1 | 8 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fever Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Bruise Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Swelling Grade 2 | 1 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Redness Grade 2 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Muscle Ache Grade 1 | 13 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 1 | 8 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Redness Grade 3 | 0 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 2 | 5 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Muscle Ache Grade 2 | 3 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Arm Motion Limitation Grade 1 | 8 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Itching Grade 1 | 5 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Lump Grade 1 | 10 participants |
| BioThrax | Incidence of Reactogenicity By Severity | Fatigue/Tiredness Grade 2 | 3 participants |
Primary
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
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
Population: Safety Population (subjects who received at least one dose of IMP)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AV7909 (Day 0 and 14) | Incidence of Serious Adverse Events | 2 participants |
| AV7909 (Day 0 and 28) | Incidence of Serious Adverse Events | 0 participants |
| AV7909 (Day 0, 14, and 28) | Incidence of Serious Adverse Events | 0 participants |
| AV7909 Reduced Dose | Incidence of Serious Adverse Events | 0 participants |
| BioThrax | Incidence of Serious Adverse Events | 1 participants |
Primary
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
Time frame: Day 63
Population: Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AV7909 (Day 0 and 14) | Toxin Neutralizing Antibody (TNA) Level at Day 63 | 56.8 percentage of participants |
| AV7909 (Day 0 and 28) | Toxin Neutralizing Antibody (TNA) Level at Day 63 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | Toxin Neutralizing Antibody (TNA) Level at Day 63 | 100 percentage of participants |
| AV7909 Reduced Dose | Toxin Neutralizing Antibody (TNA) Level at Day 63 | 90.2 percentage of participants |
| BioThrax | Toxin Neutralizing Antibody (TNA) Level at Day 63 | 52.4 percentage of participants |
Secondary
TNA Level at Day 28
Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold
Time frame: Day 28
Population: Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AV7909 (Day 0 and 14) | TNA Level at Day 28 | 83.8 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Level at Day 28 | 11.1 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Level at Day 28 | 94.4 percentage of participants |
| AV7909 Reduced Dose | TNA Level at Day 28 | 63.4 percentage of participants |
| BioThrax | TNA Level at Day 28 | 47.6 percentage of participants |
Secondary
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
Time frame: Day 42
Population: Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AV7909 (Day 0 and 14) | TNA Level at Day 42 | 86.5 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Level at Day 42 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Level at Day 42 | 94.4 percentage of participants |
| AV7909 Reduced Dose | TNA Level at Day 42 | 97.6 percentage of participants |
| BioThrax | TNA Level at Day 42 | 70.0 percentage of participants |
Secondary
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
Time frame: Up to Day 84
Population: Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 21 | 63.9 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 84 | 75.7 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 63 | 86.5 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 35 | 97.1 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 28 | 97.3 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 42 | 97.3 percentage of participants |
| AV7909 (Day 0 and 14) | TNA Seroconversion Rate | Day 49 | 91.9 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 49 | 100 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 42 | 100 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 28 | 40.7 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 21 | 55.6 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 63 | 100 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 35 | 96.3 percentage of participants |
| AV7909 (Day 0 and 28) | TNA Seroconversion Rate | Day 84 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 42 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 21 | 77.8 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 28 | 94.4 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 35 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 49 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 63 | 100 percentage of participants |
| AV7909 (Day 0, 14, and 28) | TNA Seroconversion Rate | Day 84 | 100 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 35 | 95.0 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 49 | 97.6 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 28 | 92.7 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 84 | 97.4 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 63 | 97.6 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 21 | 22.0 percentage of participants |
| AV7909 Reduced Dose | TNA Seroconversion Rate | Day 42 | 100 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 35 | 66.7 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 84 | 63.2 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 63 | 85.7 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 49 | 95.0 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 28 | 57.1 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 21 | 14.3 percentage of participants |
| BioThrax | TNA Seroconversion Rate | Day 42 | 95.0 percentage of participants |