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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272200800051C | Other Grant/Funding Number | BARDA/NIAID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Department of Health and Human Services | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioThrax | Active Comparator | BioThrax, 0.5 mL AVA per dose |
|
| AV7909 Formulation 1 | Experimental | 0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose |
|
| AV7909 Formulation 2 | Experimental | 0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose |
|
| AV7909 Formulation 3 | Experimental | 0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose |
|
| AV7909 Formulation 4 | Experimental | 0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose |
|
| Control | Placebo Comparator | Saline control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioThrax | Biological | BioThrax |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
For all other ISRs, the following scale was used:
| 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:
For all other ISRs, the following scale was used:
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Bernton, MD | Emergent Biosolutions, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| North Carolina Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23701746 | Result | Hopkins RJ, Daczkowski NF, Kaptur PE, Muse D, Sheldon E, LaForce C, Sari S, Rudge TL, Bernton E. Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers. Vaccine. 2013 Jun 26;31(30):3051-8. doi: 10.1016/j.vaccine.2013.04.063. Epub 2013 May 10. |
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All 105 enrolled participants who met inclusion and exclusion criteria were dosed.
Participants were enrolled from 27 December 2010 to 08 March 2012 at three medical centers in the U.S.
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| ID | Title | Description |
|---|---|---|
| FG000 | BioThrax | Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 |
| FG001 | AV7909 Formulation 1 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| AV7909 Formulation 1 | Biological | AV7909 Formulation 1 |
|
| AV7909 Formulation 2 | Biological | AV7909 Formulation 2 |
|
| AV7909 Formulation 3 | Biological | AV7909 Formulation 3 |
|
| AV7909 Formulation 4 | Biological | AV7909 Formulation 4 |
|
| Control | Drug | Saline control |
|
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:
For all other ISRs, the following scale was used:
|
| 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:
For all other ISRs, the following scale was used:
| 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:
For all other systemic reactions, the following scale was used:
| 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:
For all other systemic reactions, the following scale was used:
| 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:
For all other systemic reactions, the following scale was used:
| 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:
For all other systemic reactions, the following scale was used:
| 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. | 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. | Days 0-56 |
| 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. | 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. | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. |
| Raleigh |
| North Carolina |
| 27607 |
| United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| FG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| FG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| FG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| FG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BioThrax | Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 |
| BG001 | AV7909 Formulation 1 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| BG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| BG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| BG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| BG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
For all other ISRs, the following scale was used:
| Posted | Number | Participants | Days 0-6 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean titer | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other ISRs, the following scale was used:
| Posted | Number | Percentage of Participants | Days 0-6 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other ISRs, the following scale was used:
| Posted | Number | Participants | Days 14-20 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other ISRs, the following scale was used:
| Posted | Number | Percentage of Participants | Days 14-20 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other systemic reactions, the following scale was used:
| Posted | Number | Participants | Days 0-6 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other systemic reactions, the following scale was used:
| Posted | Number | percentage of participants | Days 0-6 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other systemic reactions, the following scale was used:
| Posted | Number | participants | Days 14-20 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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:
For all other systemic reactions, the following scale was used:
| Posted | Number | percentage of participants | Days 14-20 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | participants | Days 0-56 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | percentage of participants | Days 0-56 |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). | Posted | Median | Full Range | days | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). | Posted | Geometric Mean | 95% Confidence Interval | geometric mean titer | Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84. |
|
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.
Serious adverse events were coded using Medical Dictionary for Regulatory Activities (MedDRA®) Version 14.0.
Severity of laboratory toxicities were assessed using the Toxicity Grading Scale in the protocol.
For determination of Other Adverse Events frequency, all study Arms were combined.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BioThrax | Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 | 0 | 18 | 16 | 18 | ||
| EG001 | AV7909 Formulation 1 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 1 | 18 | 18 | 18 | ||
| EG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 1 | 17 | 14 | 17 | ||
| EG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 0 | 19 | 14 | 19 | ||
| EG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 | 0 | 18 | 18 | 18 | ||
| EG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 | 1 | 15 | 9 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated hepatic enzymes | Investigations | MedDRA (14.0) | Systematic Assessment | Elevated hepatic enzymes (Grade 4 elevated Alanine aminotransferase [ALT], Grade 3 elevated Aspartate aminotransferase [AST]) on Day 28 was attributed to an acute Epstein-Barr infection (unrelated to vaccination). |
|
| Melanocytic Naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment | Glioblastoma multiforme was reported during 6-month safety follow-up telephone call. The event was assessed as unrelated to vaccination. |
|
| Death | Social circumstances | MedDRA (14.0) | Systematic Assessment | Road traffic accident resulting in death was reported during 12-month safety follow-up telephone call. The event was assessed as unrelated to vaccination. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Injection Site Reaction | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Jaw Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Sternal Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Traumatic Lung Injury | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (14.0) |
| ||
| Hepatic enzyme increased | Investigations | MedDRA (14.0) |
| ||
| Hyperkalemia | Investigations | MedDRA (14.0) |
| ||
| Hypoglycemia | Investigations | MedDRA (14.0) |
| ||
| Hypokalemia | Investigations | MedDRA (14.0) |
| ||
| Hypomagnesemia | Investigations | MedDRA (14.0) |
| ||
| Neutropenia | Investigations | MedDRA (14.0) |
| ||
| Neutrophil count decreased | Investigations | MedDRA (14.0) |
| ||
| Protein urine | Investigations | MedDRA (14.0) |
| ||
| Red blood cells urine positive | Investigations | MedDRA (14.0) |
| ||
| White blood cell count increased | Investigations | MedDRA (14.0) |
| ||
| White blood cells urine positive | Investigations | MedDRA (14.0) |
|
Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between National Institute of Allergy and Infectious Disease (NIAID) and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Hopkins | Emergent BioSolutions | (301) 944-0136 | hopkinsr@ebsi.com |
| ID | Term |
|---|---|
| D000881 | Anthrax |
| D007239 | Infections |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C493276 | Biothrax |
| D022122 | Anthrax Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 1 Injection Site Reaction |
|
| Grade 2 Injection Site Reaction |
|
| Grade 3 Injection Site Reaction |
|
| Any Redness |
|
| Grade 1 Redness |
|
| Grade 2 Redness |
|
| Any Swelling |
|
| Grade 1 Swelling |
|
| Grade 2 Swelling |
|
| Grade 3 Swelling |
|
| Any Tenderness |
|
| Grade 1 Tenderness |
|
| Grade 2 Tenderness |
|
| Any Injection Site Pain |
|
| Grade 1 Injection Site Pain |
|
| Grade 2 Injection Site Pain |
|
| Any Injection Site Itching |
|
| Grade 1 Injection Site Itching |
|
| Grade 2 Injection Site Itching |
|
| Any Arm Motion Limitation |
|
| Grade 1 Arm Motion Limitation |
|
| Grade 2 Arm Motion Limitation |
|
| OG001 |
| AV7909 Formulation 1 |
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG006 | Male BioThrax | Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG007 | Male AV7909 Formulation 1 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG008 | Male AV7909 Formulation 2 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG009 | Male AV7909 Formulation 3 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG010 | Male AV7909 Formulation 4 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG011 | Male Saline | Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG012 | Female BioThrax | Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG013 | Female AV7909 Formulation 1 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG014 | Female AV7909 Formulation 2 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG015 | Female AV7909 Formulation 3 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG016 | Female AV7909 Formulation 4 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG017 | Female Saline | Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 |
|
|
| AV7909 Formulation 1 |
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG006 | Male BioThrax | Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG007 | Male AV7909 Formulation 1 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG008 | Male AV7909 Formulation 2 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG009 | Male AV7909 Formulation 3 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG010 | Male AV7909 Formulation 4 | Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG011 | Male Saline | Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG012 | Female BioThrax | Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG013 | Female AV7909 Formulation 1 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG014 | Female AV7909 Formulation 2 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG015 | Female AV7909 Formulation 3 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG016 | Female AV7909 Formulation 4 | Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG017 | Female Saline | Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
|
|
Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG002 | AV7909 Formulation 2 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG003 | AV7909 Formulation 3 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG004 | AV7909 Formulation 4 | Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
| OG005 | Saline | Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100). |
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