A Phase 2 interventional study of AV7909 and BioThrax in Anthrax, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Phase 2, Interventional, and Prevention
Among 14 studies in Anthrax by Emergent BioSolutions — 5 open to participants now, 5 under way, none of them phase 3. Anthrax · Emergent BioSolutions.
Among the 14 studies in Anthrax by Emergent BioSolutions, this one is the 4th largest by enrollment of the 10 interventional ones, is one of 2 that started in 2013, is one of 3 in phase 2, and was the 6th registered.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 168 is above the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →5 of the 14 studies in Anthrax by Emergent BioSolutions are open now.
Of the 4 Anthrax studies recruiting now, 4 (100%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2013.
Median enrollment 142 across the 10 interventional studies, 55 across the 4 observational. Of the 9 that completed or were terminated, 7 (78%) have results posted.
Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
2 of the studies in Anthrax by Emergent BioSolutions that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03569514Emergent BioSolutionsObservational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax | 2027-07 |
| NCT03569553Emergent BioSolutionsA Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients | 2027-07 |
Among the 14 studies in Anthrax by Emergent BioSolutions, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14
Biological: AV7909
Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
Biological: AV7909
Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
Biological: AV7909
Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28
Biological: AV7909
Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28
Biological: BioThrax
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
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
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
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
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
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
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
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
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
Participants were enrolled from 16 January 2013 to 14 November 2013 at 4 medical centers in the United States.
| Milestone | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Started | 44 | 34 | 23 | 44 | 23 |
| Treated | 44 | 34 | 23 | 44 | 23 |
| Completed | 42 | 31 | 22 | 42 | 21 |
| Not completed | 2 | 3 | 1 | 2 | 2 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 2 | 0 | 0 | 1 |
| Withdrew: Sponsor terminated subject | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Moving out of state | 0 | 1 | 0 | 0 | 0 |
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
| percentage of participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Toxin Neutralizing Antibody (TNA) Level at Day 63 | 56.8 (39.5 to 72.9) | 100 (87.2 to 100) | 100 (81.5 to 100) | 90.2 (76.9 to 97.3) | 52.4 (29.8 to 74.3) |
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
| participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Incidence of Adverse Events | 36 | 26 | 17 | 35 | 15 |
Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold
| percentage of participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| TNA Level at Day 42 | 86.5 (71.2 to 95.5) | 100 (86.8 to 100) | 94.4 (72.7 to 99.9) | 97.6 (87.1 to 99.9) | 70.0 (45.7 to 88.1) |
Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold
| percentage of participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| TNA Level at Day 28 | 83.8 (68.0 to 93.8) | 11.1 (2.4 to 29.2) | 94.4 (72.7 to 99.9) | 63.4 (46.9 to 77.9) | 47.6 (25.7 to 70.2) |
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
| percentage of participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Day 21 | 63.9 (46.2 to 79.2) | 55.6 (35.3 to 74.5) | 77.8 (52.4 to 93.6) | 22.0 (10.6 to 37.6) | 14.3 (3.0 to 36.3) |
| Day 28 | 97.3 (85.8 to 99.9) | 40.7 (22.4 to 61.2) | 94.4 (72.7 to 99.9) | 92.7 (80.1 to 98.5) | 57.1 (34.0 to 78.2) |
| Day 35 | 97.1 (85.1 to 99.9) | 96.3 (81.0 to 99.9) | 100 (81.5 to 100) | 95.0 (83.1 to 99.4) | 66.7 (41.0 to 86.7) |
| Day 42 | 97.3 (85.8 to 99.9) | 100 (86.8 to 100) | 100 (81.5 to 100) | 100 (91.4 to 100) | 95.0 (75.1 to 99.9) |
| Day 49 | 91.9 (78.1 to 98.3) | 100 (85.8 to 100) | 100 (81.5 to 100) | 97.6 (87.1 to 99.9) | 95.0 (75.1 to 99.9) |
| Day 63 | 86.5 (71.2 to 95.5) | 100 (87.2 to 100) | 100 (81.5 to 100) | 97.6 (87.1 to 99.9) | 85.7 (63.7 to 97.0) |
| Day 84 | 75.7 (58.8 to 88.2) | 100 (86.8 to 100) | 100 (81.5 to 100) | 97.4 (86.5 to 99.9) | 63.2 (38.4 to 83.7) |
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
| participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Incidence of Serious Adverse Events | 2 | 0 | 0 | 0 | 1 |
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.
| participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Fatigue/Tiredness Grade 1 | 11 | 17 | 14 | 19 | 8 |
| Fatigue/Tiredness Grade 2 | 6 | 5 | 1 | 2 | 3 |
| Fatigue/Tiredness Grade 3 | 3 | 0 | 1 | 0 | 0 |
| Muscle Ache Grade 1 | 25 | 19 | 13 | 27 | 13 |
| Muscle Ache Grade 2 | 6 | 6 | 7 | 9 | 3 |
| Muscle Ache Grade 3 | 2 | 0 | 0 | 0 | 0 |
| Headache Grade 1 | 10 | 15 | 9 | 14 | 8 |
| Headache Grade 2 | 7 | 3 | 6 | 7 | 1 |
| Headache Grade 3 | 4 | 0 | 0 | 0 | 0 |
| Fever Grade 1 | 0 | 0 | 0 | 0 | 0 |
| Fever Grade 2 | 0 | 1 | 0 | 0 | 0 |
| Fever Grade 3 | 2 | 0 | 0 | 0 | 0 |
| Warmth Grade 1 | 17 | 15 | 11 | 14 | 11 |
| Warmth Grade 2 | 1 | 0 | 2 | 2 | 0 |
| Warmth Grade 3 | 0 | 0 | 1 | 0 | 0 |
| Tenderness Grade 1 | 31 | 27 | 17 | 29 | 14 |
| Tenderness Grade 2 | 11 | 6 | 5 | 9 | 5 |
| Tenderness Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Itching Grade 1 | 5 | 3 | 3 | 10 | 5 |
| Itching Grade 2 | 2 | 0 | 0 | 0 | 0 |
| Itching Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Pain Grade 1 | 30 | 29 | 15 | 29 | 14 |
| Pain Grade 2 | 9 | 2 | 7 | 8 | 6 |
| Pain Grade 3 | 1 | 0 | 0 | 0 | 0 |
| Arm Motion Limitation Grade 1 | 21 | 15 | 11 | 17 | 8 |
| Arm Motion Limitation Grade 2 | 11 | 9 | 7 | 11 | 5 |
| Arm Motion Limitation Grade 3 | 1 | 0 | 0 | 0 | 0 |
| Redness Grade 1 | 6 | 5 | 3 | 10 | 8 |
| Redness Grade 2 | 2 | 1 | 1 | 1 | 0 |
| Redness Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Lump Grade 1 | 13 | 6 | 9 | 16 | 10 |
| Lump Grade 2 | 0 | 0 | 0 | 0 | 0 |
| Lump Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Swelling Grade 1 | 12 | 7 | 7 | 14 | 7 |
| Swelling Grade 2 | 0 | 0 | 2 | 0 | 1 |
| Swelling Grade 3 | 0 | 0 | 0 | 0 | 0 |
| Bruise Grade 1 | 4 | 6 | 2 | 8 | 4 |
| Bruise Grade 2 | 0 | 0 | 0 | 0 | 0 |
| Bruise Grade 3 | 0 | 0 | 0 | 0 | 0 |
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.
| participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Hemoglobin | 39 | 29 | 20 | 42 | 19 |
| Leukocytes | 8 | 4 | 3 | 3 | 0 |
| Neutrophils | 2 | 1 | 1 | 3 | 0 |
| Lymphocytes | 0 | 1 | 4 | 2 | 0 |
| Aspartate Aminotransferase | 3 | 2 | 3 | 4 | 1 |
| Alanine Aminotransferase | 2 | 3 | 1 | 3 | 2 |
| Glucose | 9 | 7 | 8 | 13 | 2 |
| Glucose Fasting | 0 | 0 | 1 | 0 | 0 |
| Bilirubin | 1 | 2 | 1 | 0 | 1 |
| Blood Urea Nitrogen | 1 | 0 | 1 | 1 | 0 |
| Urine Glucose | 2 | 1 | 0 | 0 | 1 |
| Urine Protein | 16 | 10 | 5 | 13 | 6 |
| Urine Erythrocytes | 11 | 5 | 4 | 7 | 8 |
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
| participants | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Incidence of Immunologically Significant Adverse Events of Special Interest | 0 | 0 | 0 | 0 | 0 |
Collected over From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AV7909 (Day 0 and 14) | — | 2/44 (4.5%) | 32/44 (72.7%) |
| AV7909 (Day 0 and 28) | — | 0/34 (0%) | 18/34 (52.9%) |
| AV7909 (Day 0, 14, and 28) | — | 0/23 (0%) | 10/23 (43.5%) |
| AV7909 Reduced Dose | — | 0/44 (0%) | 27/44 (61.4%) |
| BioThrax | — | 1/23 (4.3%) | 9/23 (39.1%) |
| Event | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| PyelonephritisInfections and infestations | 0/44 | 0/34 | 0/23 | 0/44 | 1/23 |
| CellulitisInfections and infestations | 1/44 | 0/34 | 0/23 | 0/44 | 0/23 |
| Rectal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/44 | 0/34 | 0/23 | 0/44 | 0/23 |
| Atelectasis neonatalRespiratory, thoracic and mediastinal disorders | 1/44 | 0/34 | 0/23 | 0/44 | 0/23 |
| Event | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 10/44 | 5/34 | 2/23 | 7/44 | 2/23 |
| Respiratory rate increasedInvestigations | 6/44 | 2/34 | 4/23 | 10/44 | 2/23 |
| Vulvovaginal mycotic infectionInfections and infestations | 0/22 | 0/17 | 0/11 | 0/22 | 2/11 |
| Red blood cells urine positiveInvestigations | 2/44 | 0/34 | 0/23 | 0/44 | 4/23 |
| NasopharyngitisInfections and infestations | 7/44 | 3/34 | 0/23 | 2/44 | 1/23 |
| Blood pressure diastolic decreasedInvestigations | 5/44 | 3/34 | 2/23 | 6/44 | 0/23 |
| Heart rate decreasedInvestigations | 1/44 | 4/34 | 0/23 | 1/44 | 2/23 |
| BradycardiaCardiac disorders | 2/44 | 0/34 | 1/23 | 5/44 | 0/23 |
| Urinary tract infectionInfections and infestations | 0/44 | 1/34 | 2/23 | 1/44 | 0/23 |
| Protein urine presentInvestigations | 0/44 | 0/34 | 0/23 | 0/44 | 2/23 |
Intent-to-treat Population
| Age, Continuous(years) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| Mean | 33.4 ± 9.0 | 32.7 ± 9.7 | 29.7 ± 10.2 | 32.8 ± 9.2 | 32.5 ± 10.4 | 32.5 ± 9.5 |
| Age, Categorical(Participants) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 2 | 1 | 0 | 1 | 4 |
| Between 18 and 65 years | 44 | 32 | 22 | 44 | 22 | 164 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| Female | 22 | 17 | 11 | 22 | 11 | 83 |
| Male | 22 | 17 | 12 | 22 | 12 | 85 |
| Race (NIH/OMB)(Participants) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 3 | 1 | 3 | 3 | 2 | 12 |
| White | 40 | 33 | 20 | 40 | 21 | 154 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 9 | 7 | 4 | 5 | 4 | 29 |
| Not Hispanic or Latino | 35 | 27 | 19 | 39 | 19 | 139 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | AV7909 (Day 0 and 14) | AV7909 (Day 0 and 28) | AV7909 (Day 0, 14, and 28) | AV7909 Reduced Dose | BioThrax | Total |
|---|---|---|---|---|---|---|
| United States | 44 | 34 | 23 | 44 | 23 | 168 |
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Studies of the drug tested here: AV7909