A Phase 1 interventional study of BioThrax and AV7909 Formulation 1 in Bacillus Anthracis (Anthrax) Infection, sponsored by Emergent BioSolutions. Completed at 3 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 1, Interventional, and Prevention
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, and one which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen. In the current study, the safety, tolerability, and antibody response to PA will be studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I volunteer study of CPG 7909 combined with AVA.
75 studies on the registry are indexed under Anthrax; 12 are open to participants now.
This study's enrollment of 105 is close to the median of 100 across 57 interventional studies indexed under Anthrax.
Browse Anthrax studies →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.
Counted across the registry records on this site, refreshed daily.
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:
Key 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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
BioThrax, 0.5 mL AVA per dose
Biological: BioThrax
0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose
Biological: AV7909 Formulation 1
0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose
Biological: AV7909 Formulation 2
0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose
Biological: AV7909 Formulation 3
0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose
Biological: AV7909 Formulation 4
Saline control
Drug: Control
BioThrax
Also known as: Anthrax Vaccine Adsorbed (AVA)
AV7909 Formulation 1
AV7909 Formulation 2
AV7909 Formulation 3
AV7909 Formulation 4
Saline control
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
Percentage of Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 0-6
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
Percentage of Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
Time frame: Days 14-20
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
Time frame: Days 0-56
Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
Time frame: Days 0-56
Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14.
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Participants were enrolled from 27 December 2010 to 08 March 2012 at three medical centers in the U.S.
| Milestone | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Started | 18 | 18 | 17 | 19 | 18 | 15 |
| Completed | 15 | 18 | 16 | 18 | 18 | 15 |
| Not completed | 3 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 |
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| Participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Injection Site Reaction | 11 | 17 | 13 | 12 | 16 | 1 |
| Grade 1 Injection Site Reaction | 9 | 9 | 11 | 6 | 11 | 1 |
| Grade 2 Injection Site Reaction | 1 | 6 | 2 | 6 | 5 | 0 |
| Grade 3 Injection Site Reaction | 1 | 2 | 0 | 0 | 0 | 0 |
| Any Redness | 0 | 2 | 1 | 2 | 1 | 0 |
| Grade 1 Redness | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Redness | 0 | 1 | 1 | 2 | 1 | 0 |
| Any Swelling | 1 | 4 | 1 | 1 | 2 | 0 |
| Grade 1 Swelling | 0 | 0 | 1 | 0 | 1 | 0 |
| Grade 2 Swelling | 0 | 2 | 0 | 1 | 1 | 0 |
| Grade 3 Swelling | 1 | 2 | 0 | 0 | 0 | 0 |
| Any Tenderness | 10 | 16 | 11 | 11 | 13 | 1 |
| Grade 1 Tenderness | 9 | 13 | 10 | 10 | 11 | 1 |
| Grade 2 Tenderness | 1 | 3 | 1 | 1 | 2 | 0 |
| Any Injection Site Pain | 5 | 14 | 12 | 8 | 11 | 0 |
| Grade 1 Injection Site Pain | 4 | 12 | 12 | 7 | 8 | 0 |
| Grade 2 Injection Site Pain | 1 | 2 | 0 | 1 | 3 | 0 |
| Any Injection Site Itching | 0 | 2 | 2 | 0 | 0 | 0 |
| Grade 1 Injection Site Itching | 0 | 1 | 2 | 0 | 0 | 0 |
| Grade 2 Injection Site Itching | 0 | 1 | 0 | 0 | 0 | 0 |
| Any Arm Motion Limitation | 8 | 13 | 8 | 9 | 10 | 0 |
| Grade 1 Arm Motion Limitation | 7 | 8 | 7 | 4 | 6 | 0 |
| Grade 2 Arm Motion Limitation | 1 | 5 | 1 | 5 | 4 | 0 |
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the lower limit of quantitation (LLOQ) of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
| geometric mean titer | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Male BioThrax | Male AV7909 Formulation 1 | Male AV7909 Formulation 2 | Male AV7909 Formulation 3 | Male AV7909 Formulation 4 | Male Saline | Female BioThrax | Female AV7909 Formulation 1 | Female AV7909 Formulation 2 | Female AV7909 Formulation 3 | Female AV7909 Formulation 4 | Female Saline |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 0.15 (0.07 to 0.30) | 3.40 (2.33 to 4.94) | 4.02 (2.46 to 6.57) | 2.81 (1.50 to 5.26) | 1.93 (0.85 to 4.43) | 0.04 (0.02 to 0.08) | 0.19 (0.06 to 0.62) | 3.44 (1.84 to 6.43) | 4.19 (2.19 to 7.98) | 2.99 (1.32 to 6.78) | 2.45 (0.54 to 11.12) | 0.03 (NA to NA) | 0.11 (0.04 to 0.36) | 3.35 (1.91 to 5.88) | 3.87 (1.54 to 9.71) | 2.68 (0.92 to 7.80) | 1.53 (0.53 to 4.39) | 0.06 (0.01 to 0.21) |
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the first injection (Day 0). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| Percentage of Participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Injection Site Reaction | 61.1 | 94.4 | 76.5 | 63.2 | 88.9 | 6.7 |
| Grade 1 Injection Site Reaction | 50.0 | 50.0 | 64.7 | 31.6 | 61.1 | 6.7 |
| Grade 2 Injection Site Reaction | 5.6 | 33.3 | 11.8 | 31.6 | 27.8 | 0 |
| Grade 3 Injection Site Reaction | 5.6 | 11.1 | 0 | 0 | 0 | 0 |
| Any Redness | 0 | 11.1 | 5.9 | 10.5 | 5.6 | 0 |
| Grade 1 Redness | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Grade 2 Redness | 0 | 5.6 | 5.9 | 10.5 | 5.6 | 0 |
| Any Swelling | 5.6 | 22.2 | 5.9 | 5.3 | 11.1 | 0 |
| Grade 1 Swelling | 0 | 0 | 5.9 | 0 | 5.6 | 0 |
| Grade 2 Swelling | 0 | 11.1 | 0 | 5.3 | 5.6 | 0 |
| Grade 3 Swelling | 5.6 | 11.1 | 0 | 0 | 0 | 0 |
| Any Tenderness | 55.6 | 88.9 | 64.7 | 57.9 | 72.2 | 6.7 |
| Grade 1 Tenderness | 50.0 | 72.2 | 58.8 | 52.6 | 61.1 | 6.7 |
| Grade 2 Tenderness | 5.6 | 16.7 | 5.9 | 5.3 | 11.1 | 0 |
| Any Injection Site Pain | 27.8 | 77.8 | 70.6 | 42.1 | 61.1 | 0 |
| Grade 1 Injection Site Pain | 22.2 | 66.7 | 70.6 | 36.8 | 44.4 | 0 |
| Grade 2 Injection Site Pain | 5.6 | 11.1 | 0 | 5.3 | 16.7 | 0 |
| Any Injection Site Itching | 0 | 11.1 | 11.8 | 0 | 0 | 0 |
| Grade 1 Injection Site Itching | 0 | 5.6 | 11.8 | 0 | 0 | 0 |
| Grade 2 Injection Site Itching | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Any Arm Motion Limitation | 44.4 | 72.2 | 47.1 | 47.4 | 55.6 | 0 |
| Grade 1 Arm Motion Limitation | 38.9 | 44.4 | 41.2 | 21.1 | 33.3 | 0 |
| Grade 2 Arm Motion Limitation | 5.6 | 27.8 | 5.9 | 26.3 | 22.2 | 0 |
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| Participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Injection Site Reaction | 11 | 16 | 12 | 11 | 13 | 0 |
| Grade 1 Injection Site Reaction | 6 | 8 | 9 | 6 | 7 | 0 |
| Grade 2 Injection Site Reaction | 4 | 6 | 3 | 3 | 6 | 0 |
| Grade 3 Injection Site Reaction | 1 | 2 | 0 | 2 | 0 | 0 |
| Any Redness | 1 | 3 | 2 | 3 | 0 | 0 |
| Grade 1 Redness | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Redness | 1 | 3 | 2 | 2 | 0 | 0 |
| Grade 3 Redness | 0 | 0 | 0 | 1 | 0 | 0 |
| Any Swelling | 2 | 4 | 2 | 2 | 1 | 0 |
| Grade 1 Swelling | 0 | 0 | 0 | 0 | 1 | 0 |
| Grade 2 Swelling | 2 | 3 | 2 | 2 | 0 | 0 |
| Grade 3 Swelling | 0 | 1 | 0 | 0 | 0 | 0 |
| Any Tenderness | 11 | 13 | 11 | 10 | 12 | 0 |
| Grade 1 Tenderness | 8 | 8 | 11 | 8 | 9 | 0 |
| Grade 2 Tenderness | 2 | 5 | 0 | 2 | 3 | 0 |
| Grade 3 Tenderness | 1 | 0 | 0 | 0 | 0 | 0 |
| Any Injection Site Pain | 6 | 13 | 10 | 8 | 6 | 0 |
| Grade 1 Injection Site Pain | 2 | 10 | 10 | 6 | 3 | 0 |
| Grade 2 Injection Site Pain | 3 | 2 | 0 | 2 | 3 | 0 |
| Grade 3 Injection Site Pain | 1 | 1 | 0 | 0 | 0 | 0 |
| Any Injection Site Itching | 2 | 3 | 3 | 2 | 0 | 0 |
| Grade 1 Injection Site Itching | 2 | 2 | 3 | 2 | 0 | 0 |
| Grade 3 Injection Site Itching | 0 | 1 | 0 | 0 | 0 | 0 |
| Any Arm Motion Limitation | 8 | 11 | 7 | 8 | 8 | 0 |
| Grade 1 Arm Motion Limitation | 4 | 6 | 6 | 4 | 3 | 0 |
| Grade 2 Arm Motion Limitation | 3 | 4 | 1 | 3 | 5 | 0 |
| Grade 3 Arm Motion Limitation | 1 | 1 | 0 | 1 | 0 | 0 |
Subjects recorded solicited injection site reactions (ISRs) (redness, swelling, tenderness, pain, itching, arm motion limitation) on diary cards for 7 days following the second injection (Day 14). All local reactions collected by subjects on diary cards were recorded as adverse events. Severity of ISR was assessed using a grading scale based on FDA Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Swelling/edema and redness/erythema were graded by the greater of two perpendicular measurements of diameter rated as follows: * Grade 0: none * Grade 1: \<3 cm * Grade 2: 3 to 10 cm * Grade 3: \>10 cm For all other ISRs, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| Percentage of Participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Injection Site Reaction | 61.1 | 88.9 | 70.6 | 57.9 | 72.2 | 0 |
| Grade 1 Injection Site Reaction | 33.3 | 44.4 | 52.9 | 31.6 | 38.9 | 0 |
| Grade 2 Injection Site Reaction | 22.2 | 33.3 | 17.6 | 15.8 | 33.3 | 0 |
| Grade 3 Injection Site Reaction | 5.6 | 11.1 | 0 | 10.5 | 0 | 0 |
| Any Redness | 5.6 | 16.7 | 11.8 | 15.8 | 0 | 0 |
| Grade 2 Redness | 5.6 | 16.7 | 11.8 | 10.5 | 0 | 0 |
| Grade 3 Redness | 0 | 0 | 0 | 5.3 | 0 | 0 |
| Any Swelling | 11.1 | 22.2 | 11.8 | 10.5 | 5.6 | 0 |
| Grade 1 Swelling | 0 | 0 | 0 | 0 | 5.6 | 0 |
| Grade 2 Swelling | 11.1 | 16.7 | 11.8 | 10.5 | 0 | 0 |
| Grade 3 Swelling | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Any Tenderness | 61.1 | 72.2 | 64.7 | 52.6 | 66.7 | 0 |
| Grade 1 Tenderness | 44.4 | 44.14 | 64.7 | 42.1 | 50.0 | 0 |
| Grade 2 Tenderness | 11.1 | 27.8 | 0 | 10.5 | 16.7 | 0 |
| Grade 3 Tenderness | 5.6 | 0 | 0 | 0 | 0 | 0 |
| Any Injection Site Pain | 33.3 | 72.2 | 58.8 | 42.1 | 33.3 | 0 |
| Grade 1 Injection Site Pain | 11.1 | 55.6 | 58.8 | 31.6 | 16.7 | 0 |
| Grade 2 Injection Site Pain | 16.7 | 11.1 | 0 | 10.5 | 16.7 | 0 |
| Grade 3 Injection Site Pain | 5.6 | 5.6 | 0 | 0 | 0 | 0 |
| Any Injection Site Itching | 11.1 | 16.7 | 17.6 | 10.5 | 0 | 0 |
| Grade 1 Injection Site Itching | 11.1 | 11.1 | 17.6 | 10.5 | 0 | 0 |
| Grade 3 Injection Site Itching | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Any Arm Motion Limitation | 44.4 | 61.1 | 41.2 | 42.1 | 44.4 | 0 |
| Grade 1 Arm Motion Limitation | 22.2 | 33.3 | 35.3 | 21.1 | 16.7 | 0 |
| Grade 2 Arm Motion Limitation | 16.7 | 22.2 | 5.9 | 15.8 | 27.8 | 0 |
| Grade 3 Arm Motion Limitation | 5.6 | 5.6 | 0 | 5.3 | 0 | 0 |
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| Participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Systemic Reaction | 10 | 12 | 7 | 3 | 7 | 5 |
| Grade 1 Systemic Reaction | 8 | 5 | 5 | 3 | 2 | 4 |
| Grade 2 Systemic Reaction | 2 | 7 | 2 | 0 | 4 | 1 |
| Grade 3 Systemic Reaction | 0 | 0 | 0 | 0 | 1 | 0 |
| Any Fever | 0 | 2 | 1 | 0 | 0 | 2 |
| Grade 1 Fever | 0 | 2 | 1 | 0 | 0 | 2 |
| Any Fatigue | 6 | 9 | 3 | 3 | 4 | 2 |
| Grade 1 Fatigue | 5 | 4 | 1 | 3 | 2 | 2 |
| Grade 2 Fatigue | 1 | 5 | 2 | 0 | 2 | 0 |
| Any Muscle Ache | 4 | 8 | 3 | 0 | 2 | 2 |
| Grade 1 Muscle Ache | 4 | 6 | 1 | 0 | 2 | 1 |
| Grade 2 Muscle Ache | 0 | 2 | 2 | 0 | 0 | 1 |
| Any Headache | 6 | 11 | 5 | 1 | 5 | 2 |
| Grade 1 Headache | 6 | 4 | 3 | 1 | 1 | 1 |
| Grade 2 Headache | 0 | 7 | 2 | 0 | 3 | 1 |
| Grade 3 Headache | 0 | 0 | 0 | 0 | 1 | 0 |
| Any Nausea / GI Upset | 1 | 4 | 2 | 2 | 2 | 2 |
| Grade 1 Nausea / GI Upset | 0 | 1 | 2 | 2 | 2 | 1 |
| Grade 2 Nausea / GI Upset | 1 | 3 | 0 | 0 | 0 | 1 |
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| percentage of participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Systemic Reaction | 55.6 | 66.7 | 41.2 | 15.8 | 38.9 | 33.3 |
| Grade 1 Systemic Reaction | 44.4 | 27.8 | 29.4 | 15.8 | 11.1 | 26.7 |
| Grade 2 Systemic Reactions | 11.1 | 38.9 | 11.8 | 0 | 22.2 | 6.7 |
| Grade 3 Systemic Reaction | 0 | 0 | 0 | 0 | 5.6 | 0 |
| Any Fever | 0 | 11.1 | 5.9 | 0 | 0 | 13.3 |
| Grade 1 Fever | 0 | 11.1 | 5.9 | 0 | 0 | 13.3 |
| Any Fatigue | 33.3 | 50.0 | 17.6 | 15.8 | 22.2 | 13.3 |
| Grade 1 Fatigue | 27.8 | 22.2 | 5.9 | 15.8 | 11.1 | 13.3 |
| Grade 2 Fatigue | 5.6 | 27.8 | 11.8 | 0 | 11.1 | 0 |
| Any Muscle Ache | 22.2 | 44.4 | 17.6 | 0 | 11.1 | 13.3 |
| Grade 1 Muscle Ache | 22.2 | 33.3 | 5.9 | 0 | 11.1 | 6.7 |
| Grade 2 Muscle Ache | 0 | 11.1 | 11.8 | 0 | 0 | 6.7 |
| Any Headache | 33.3 | 61.1 | 29.4 | 5.3 | 27.8 | 13.3 |
| Grade 1 Headache | 33.3 | 22.2 | 17.6 | 5.3 | 5.6 | 6.7 |
| Grade 2 Headache | 0 | 8.9 | 11.8 | 0 | 16.47 | 6.7 |
| Grade 3 Headache | 0 | 0 | 0 | 0 | 5.6 | 0 |
| Any Nausea / GI Upset | 5.6 | 22.2 | 11.8 | 10.5 | 11.1 | 13.3 |
| Grade 1 Nausea / GI Upset | 0 | 5.6 | 11.8 | 10.5 | 11.1 | 6.7 |
| Grade 2 Nausea / GI Upset | 5.6 | 16.7 | 0 | 0 | 0 | 6.7 |
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Systemic Reaction | 7 | 14 | 7 | 4 | 9 | 2 |
| Grade 1 Systemic Reaction | 3 | 8 | 6 | 2 | 4 | 1 |
| Grade 2 Systemic Reactions | 3 | 5 | 1 | 2 | 5 | 1 |
| Grade 3 Systemic Reaction | 1 | 1 | 0 | 0 | 0 | 0 |
| Any Fever | 0 | 0 | 0 | 0 | 1 | 0 |
| Grade 1 Fever | 0 | 0 | 0 | 0 | 1 | 0 |
| Any Fatigue | 4 | 8 | 4 | 3 | 7 | 1 |
| Grade 1 Fatigue | 3 | 5 | 3 | 1 | 4 | 1 |
| Grade 2 Fatigue | 1 | 2 | 1 | 2 | 3 | 0 |
| Grade 3 Fatigue | 0 | 1 | 0 | 0 | 0 | 0 |
| Any Muscle Ache | 5 | 9 | 3 | 2 | 7 | 0 |
| Grade 1 Muscle Ache | 3 | 5 | 2 | 1 | 4 | 0 |
| Grade 2 Muscle Ache | 1 | 3 | 1 | 1 | 3 | 0 |
| Grade 3 Muscle Ache | 1 | 1 | 0 | 0 | 0 | 0 |
| Any Headache | 5 | 7 | 3 | 3 | 7 | 1 |
| Grade 1 Headache | 2 | 5 | 3 | 2 | 3 | 0 |
| Grade 2 Headache | 2 | 2 | 0 | 1 | 4 | 1 |
| Grade 3 Headache | 1 | 0 | 0 | 0 | 0 | 0 |
| Any Nausea / GI Upset | 1 | 3 | 0 | 0 | 3 | 0 |
| Grade 1 Nausea / GI Upset | 1 | 2 | 0 | 0 | 2 | 0 |
| Grade 2 Nausea / GI Upset | 0 | 1 | 0 | 0 | 1 | 0 |
Subjects recorded solicited systemic reactions (fever, fatigue, muscle aching, headache, nausea/GI upset) on diary cards for 7 days following each of two injections (Days 0 and 14) All systemic reactions collected by subjects on diary cards were recorded as adverse events. Severity of systemic reactions was assessed using a grading scale based on FDA Guidance titled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials." Toxicity grades for fever were derived from body temperature using the following scale: * Grade 0: \<100°F * Grade 1: 100.0 - 101.5°F * Grade 2: 101.6 - 102.9°F ; * Grade 3: 103.0 - 105.0°F For all other systemic reactions, the following scale was used: * Grade 0: not present * Grade 1: present with no limitation of activity * Grade 2: interfering with daily activities or requiring non-narcotic treatment * Grade 3: preventing normal daily activities or requiring narcotic analgesia
| percentage of participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Any Systemic Reaction | 38.9 | 77.8 | 41.2 | 21.1 | 50.0 | 13.3 |
| Grade 1 Systemic Reaction | 16.7 | 44.14 | 35.3 | 10.5 | 22.2 | 6.7 |
| Grade 2 Systemic Reactions | 16.7 | 27.8 | 5.9 | 10.5 | 27.8 | 6.7 |
| Grade 3 Systemic Reaction | 5.6 | 5.6 | 0 | 0 | 0 | 0 |
| Any Fever | 0 | 0 | 0 | 0 | 5.6 | 0 |
| Grade 1 Fever | 0 | 0 | 0 | 0 | 5.6 | 0 |
| Any Fatigue | 22.2 | 44.4 | 23.5 | 15.8 | 38.9 | 6.7 |
| Grade 1 Fatigue | 16.7 | 27.8 | 17.6 | 5.3 | 22.2 | 6.7 |
| Grade 2 Fatigue | 5.6 | 11.1 | 5.9 | 10.5 | 16.7 | 0 |
| Grade 3 Fatigue | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Any Muscle Ache | 27.8 | 50.0 | 17.6 | 10.5 | 38.9 | 0 |
| Grade 1 Muscle Ache | 16.7 | 27.8 | 11.8 | 5.3 | 22.2 | 0 |
| Grade 2 Muscle Ache | 5.6 | 16.7 | 5.9 | 5.3 | 16.7 | 0 |
| Grade 3 Muscle Ache | 5.6 | 5.6 | 0 | 0 | 0 | 0 |
| Any Headache | 27.8 | 38.9 | 17.6 | 15.8 | 38.9 | 6.7 |
| Grade 1 Headache | 11.1 | 27.8 | 17.6 | 10.5 | 16.7 | 0 |
| Grade 2 Headache | 11.1 | 11.1 | 0 | 5.3 | 22.2 | 6.7 |
| Grade 3 Headache | 5.6 | 0 | 0 | 0 | 0 | 0 |
| Any Nausea / GI Upset | 5.6 | 16.7 | 0 | 0 | 16.7 | 0 |
| Grade 1 Nausea / GI Upset | 5.6 | 11.1 | 0 | 0 | 11.1 | 0 |
| Grade 2 Nausea / GI Upset | 0 | 5.6 | 0 | 0 | 5.6 | 0 |
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
| participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Alanine aminotransferase increased | 0 | 0 | 1 | 0 | 1 | 1 |
| Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 2 | 0 |
| Blood creatinine increased | 0 | 0 | 1 | 0 | 0 | 0 |
| Blood lactate dehydrogenase increased | 0 | 0 | 0 | 0 | 0 | 1 |
| Blood urea increased | 0 | 1 | 0 | 0 | 0 | 0 |
| Hepatic enzyme increased | 0 | 0 | 0 | 0 | 0 | 1 |
| Hyperkalemia | 0 | 1 | 0 | 0 | 0 | 0 |
| Hypoglycemia | 0 | 1 | 0 | 2 | 0 | 0 |
| Hypokalemia | 0 | 0 | 1 | 1 | 0 | 0 |
| Hypomagnesemia | 0 | 0 | 0 | 1 | 0 | 0 |
| Lymphocyte count decreased | 0 | 6 | 3 | 1 | 4 | 0 |
| Neutropenia | 1 | 1 | 0 | 0 | 0 | 0 |
| Neutrophil count decreased | 0 | 1 | 0 | 0 | 0 | 0 |
| Protein urine | 0 | 1 | 0 | 1 | 1 | 1 |
| Red blood cells urine positive | 0 | 0 | 1 | 0 | 0 | 0 |
| White blood cell count decreased | 2 | 5 | 4 | 0 | 2 | 1 |
| White blood cell count increased | 0 | 1 | 0 | 0 | 0 | 0 |
| White blood cells urine positive | 0 | 0 | 1 | 0 | 0 | 0 |
Hematology test included hemoglobin, hematocrit, white blood cell count, absolute lymphocyte count, absolute neutrophil count, absolute eosinophil count, and platelet count. Serum chemistry test included albumin, alkaline phosphatase, total bilirubin, blood urea nitrogen, creatinine, glucose, calcium, potassium, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Urinalysis included appearance, color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and occult blood. Hematology tests were done on Days 0, 1, 2, 7, 28, and 56. Serum chemistry tests and urinalysis were done on Days 0, 7, 28, and 56.
| percentage of participants | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Alanine aminotransferase increased | 0 | 0 | 5.9 | 0 | 5.6 | 6.7 |
| Aspartate aminotransferase increased | 0 | 0 | 0 | 0 | 11.1 | 0 |
| Blood creatinine increased | 0 | 0 | 5.9 | 0 | 0 | 0 |
| Blood lactate dehydrogenase increased | 0 | 0 | 0 | 0 | 0 | 6.7 |
| Blood urea increased | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Hepatic enzyme increased | 0 | 0 | 0 | 0 | 0 | 6.7 |
| Hyperkalemia | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Hypoglycemia | 0 | 5.6 | 0 | 10.5 | 0 | 0 |
| Hypokalemia | 0 | 0 | 5.9 | 5.3 | 0 | 0 |
| Hypomagnesemia | 0 | 0 | 0 | 5.3 | 0 | 0 |
| Lymphocyte count decreased | 0 | 33.3 | 17.6 | 5.3 | 22.2 | 0 |
| Neutropenia | 5.6 | 5.6 | 0 | 0 | 0 | 0 |
| Neutrophil count decreased | 0 | 5.6 | 0 | 0 | 0 | 0 |
| Protein urine | 0 | 5.6 | 0 | 5.3 | 5.6 | 6.7 |
| Red blood cells urine positive | 0 | 0 | 5.9 | 0 | 0 | 0 |
| White blood cell count decreased | 11.1 | 27.8 | 23.5 | 0 | 11.1 | 6.7 |
| White blood cell count increased | 0 | 5.6 | 0 | 0 | 0 | 0 |
| White blood cells urine positive | 0 | 0 | 5.9 | 0 | 0 | 0 |
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
| days | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Male BioThrax | Male AV7909 Formulation 1 | Male AV7909 Formulation 2 | Male AV7909 Formulation 3 | Male AV7909 Formulation 4 | Male Saline | Female BioThrax | Female AV7909 Formulation 1 | Female AV7909 Formulation 2 | Female AV7909 Formulation 3 | Female AV7909 Formulation 4 | Female Saline |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Median Time to Peak TNA NF50 GMT for All Subjects in the Immunogenicity Population and by Gender After IM Administration of Investigational Product on Days 0 and 14. | 28.0 (7 to 42) | 29.0 (21 to 42) | 28.0 (22 to 35) | 28.5 (27 to 42) | 29.0 (7 to 42) | 7.0 (6 to 70) | 28.0 (7 to 35) | 28.0 (21 to 42) | 28.0 (22 to 35) | 28.0 (28 to 39) | 28.0 (7 to 35) | 7.0 (7 to 8) | 18.5 (7 to 42) | 32.0 (28 to 36) | 28.0 (22 to 30) | 29.0 (27 to 42) | 35.0 (21 to 42) | 7.0 (6 to 70) |
Toxin neutralizing antibody (TNA) levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50). TNA NF50 is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum. Values below the LLOQ of the assay (ED50 of 33) were replaced with one-half the LLOQ (ED50 of 16.5) for calculation of geometric mean titer (GMT) and statistical analysis. GMT is based on log transformation.
| geometric mean titer | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Day 0 | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) |
| Day 7 | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.03 (NA to NA) |
| Day 14 | 0.03 (NA to NA) | 0.03 (NA to NA) | 0.04 (0.03 to 0.05) | 0.04 (0.03 to 0.06) | 0.04 (0.03 to 0.05) | 0.03 (NA to NA) |
| Day 21 | 0.04 (0.0276 to 0.0651) | 1.27 (0.78 to 2.07) | 0.77 (0.32 to 1.83) | 0.90 (0.46 to 1.75) | 0.44 (0.17 to 1.10) | 0.03 (NA to NA) |
| Day 28 | 0.13 (0.06 to 0.28) | 3.05 (2.07 to 4.52) | 3.85 (2.40 to 6.20) | 2.54 (1.26 to 5.12) | 1.73 (0.77 to 3.89) | 0.03 (NA to NA) |
| Day 35 | 0.15 (0.07 to 0.32) | 2.61 (1.82 to 3.75) | 2.89 (1.80 to 4.61) | 2.23 (1.11 to 4.45) | 1.56 (0.68 to 3.59) | 0.03 (NA to NA) |
| Day 42 | 0.13 (0.07 to 0.24) | 2.01 (1.37 to 2.95) | 2.03 (1.32 to 3.12) | 1.78 (0.95 to 3.34) | 1.17 (0.53 to 2.59) | 0.03 (NA to NA) |
| Day 56 | 0.09 (0.05 to 0.16) | 1.18 (0.81 to 1.71) | 1.52 (0.97 to 2.36) | 1.09 (0.58 to 2.07) | 0.76 (0.37 to 1.61) | 0.03 (NA to NA) |
| Day 70 | 0.06 (0.04 to 0.10) | 0.85 (0.56 to 1.29) | 0.91 (0.58 to 1.41) | 0.71 (0.40 to 1.25) | 0.55 (0.26 to 1.16) | 0.04 (0.02 to 0.08) |
| Day 84 | 0.05 (0.04 to 0.08) | 0.67 (0.42 to 1.08) | 0.69 (0.44 to 1.10) | 0.55 (0.32 to 0.94) | 0.39 (0.20 to 0.77) | 0.03 (NA to NA) |
Collected over Serious adverse event data were collected at study visits from Day 0 to Day 84 and during safety follow-up telephone calls at 6 and 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BioThrax | — | 0/18 (0%) | 16/18 (88.9%) |
| AV7909 Formulation 1 | — | 1/18 (5.6%) | 18/18 (100%) |
| AV7909 Formulation 2 | — | 1/17 (5.9%) | 14/17 (82.4%) |
| AV7909 Formulation 3 | — | 0/19 (0%) | 14/19 (73.7%) |
| AV7909 Formulation 4 | — | 0/18 (0%) | 18/18 (100%) |
| Saline | — | 1/15 (6.7%) | 9/15 (60%) |
| Event | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Elevated hepatic enzymesInvestigations | 0/18 | 0/18 | 0/17 | 0/19 | 0/18 | 1/15 |
| Melanocytic NaevusNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/18 | 0/18 | 1/17 | 0/19 | 0/18 | 0/15 |
| DeathSocial circumstances | 0/18 | 1/18 | 0/17 | 0/19 | 0/18 | 0/15 |
| Event | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline |
|---|---|---|---|---|---|---|
| Injection Site ReactionGeneral disorders | 15/18 | 18/18 | 14/17 | 14/19 | 16/18 | 2/15 |
| FatigueGeneral disorders | 8/18 | 13/18 | 6/17 | 4/19 | 9/18 | 3/15 |
| HeadacheNervous system disorders | 6/18 | 11/18 | 5/17 | 5/19 | 10/18 | 2/15 |
| MyalgiaMusculoskeletal and connective tissue disorders | 8/18 | 10/18 | 4/17 | 2/19 | 10/18 | 2/15 |
| Lymphocyte Count DecreasedInvestigations | 0/18 | 6/18 | 3/17 | 1/19 | 4/18 | 0/15 |
| NauseaGastrointestinal disorders | 2/18 | 6/18 | 3/17 | 2/19 | 4/18 | 1/15 |
| Upper Respiratory Tract InfectionInfections and infestations | 5/18 | 1/18 | 3/17 | 1/19 | 2/18 | 2/15 |
| White Blood Cell Count DecreasedInvestigations | 2/18 | 5/18 | 4/17 | 0/19 | 2/18 | 1/15 |
| PyrexiaGeneral disorders | 1/18 | 2/18 | 3/17 | 1/19 | 3/18 | 2/15 |
| Aspartate aminotransferase increasedInvestigations | 0/18 | 0/18 | 0/17 | 0/19 | 2/18 | 0/15 |
| Age, Categorical(Participants) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 1 | 1 | 2 | 1 | 0 | 0 | 5 |
| Between 18 and 65 years | 17 | 17 | 15 | 18 | 18 | 15 | 100 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| Mean | 31.1 ± 9.27 | 32.8 ± 10.31 | 32.4 ± 10.75 | 32.6 ± 9.15 | 31.4 ± 10.72 | 31.4 ± 8.61 | 32.0 ± 9.64 |
| Sex: Female, Male(Participants) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| Female | 9 | 9 | 9 | 8 | 9 | 7 | 51 |
| Male | 9 | 9 | 8 | 11 | 9 | 8 | 54 |
| Ethnicity (NIH/OMB)(Participants) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 6 | 6 | 3 | 3 | 25 |
| Not Hispanic or Latino | 14 | 15 | 11 | 13 | 15 | 12 | 80 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 1 | 6 | 3 | 2 | 15 |
| White | 15 | 17 | 15 | 12 | 15 | 13 | 87 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Region of Enrollment(participants) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| United States | 18 | 18 | 17 | 19 | 18 | 15 | 105 |
| Weight(kilograms) | BioThrax | AV7909 Formulation 1 | AV7909 Formulation 2 | AV7909 Formulation 3 | AV7909 Formulation 4 | Saline | Total |
|---|---|---|---|---|---|---|---|
| Mean | 80.06 ± 18.799 | 83.99 ± 16.137 | 75.75 ± 12.232 | 78.39 ± 19.021 | 76.24 ± 15.649 | 79.74 ± 23.140 | 79.03 ± 17.487 |
The record gives a start of Dec 2010, a primary completion of May 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 2 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AV7909