Bacillus Anthracis (Anthrax) InfectionPhase 1NCT01263691
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
A Phase 1 study testing BioThrax, AV7909 Formulation 1 and AV7909 Formulation 2 in people with Bacillus Anthracis (Anthrax) Infection, run by Emergent BioSolutions at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacillus Anthracis (Anthrax) Infection
- What is being tested?
- BioThrax, AV7909 Formulation 1 and AV7909 Formulation 2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Jun 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 50 years of age, inclusive, at the time of enrollment.
- Be in good health as determined by the investigator from medical history and a physical examination.
- If a pre-menopausal female, must be using acceptable methods of birth control.
- Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
- Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc).
- Be willing and capable of complying with all aspects of the protocol through completion of the required visits.
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- Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing.
- Have adequate venous access for repeat phlebotomies.
- Have read, understood and signed an informed consent form.
Who cannot join
- A known anaphylactic response, severe systematic response, or serious hypersensitivity reaction to a prior immunization.
- Prior immunization with anthrax vaccine, recombinant Protective Antigen (rPA) vaccine, or known exposure to anthrax organisms.
- Have previously served in the military or plans to enlist in the military from Screening through Day 84.
- Have participated in anthrax therapeutic or vaccine trials (monoclonal anti-protective antigen (PA) or anthrax immune globulins or anthrax vaccines).
- Participation in any investigational clinical trial within 30 days preceding the Screening visit or planning to participate in a clinical trial requiring dosing through the Day 194 visit.
- A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methylenedioxymethamphetamine opiates, oxycodone, phencyclidine, propoxyphene, or tricyclic antidepressants.
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- Blood pressure greater than 145 millimeters of mercury (mmHg) systolic or 90 mmHg diastolic.
- Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis, glomerulonephritis, or autoimmune thyroiditis.
- A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Miami Research Associates
Miami, Florida, 33143
North Carolina Clinical Research
Raleigh, North Carolina, 27607
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: A Parallel-arm, Double-blind, Randomized, Placebo-controlled, Dose-ranging Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of AV7909 in Healthy Adults
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.
Read the detailed description
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.
- Conditions
- Bacillus Anthracis (Anthrax) Infection
- Being tested
- BioThrax, AV7909 Formulation 1, AV7909 Formulation 2, AV7909 Formulation 3, AV7909 Formulation 4
- Keywords
- AVA, AV7909, Anthrax vaccine
- Medical subject headings
- Anthrax, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioThraxBiological
Also called Anthrax Vaccine Adsorbed (AVA)
BioThrax
AV7909 Formulation 1Biological
AV7909 Formulation 1
AV7909 Formulation 2Biological
AV7909 Formulation 2
AV7909 Formulation 3Biological
AV7909 Formulation 3
AV7909 Formulation 4Biological
AV7909 Formulation 4
ControlDrug
Saline control
| Study group | Role | What they receive |
|---|---|---|
| BioThrax | Active comparator | BioThrax, 0.5 mL AVA per dose Receives: Biological: BioThrax |
| AV7909 Formulation 1 | Experimental | 0.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose Receives: Biological: AV7909 Formulation 1 |
| AV7909 Formulation 2 | Experimental | 0.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose Receives: Biological: AV7909 Formulation 2 |
| AV7909 Formulation 3 | Experimental | 0.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose Receives: Biological: AV7909 Formulation 3 |
| AV7909 Formulation 4 | Experimental | 0.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose Receives: Biological: AV7909 Formulation 4 |
| Control | Placebo comparator | Saline control Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Days 0-56
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacillus Anthracis (Anthrax) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Edward Bernton, MD, Study director, Emergent Biosolutions, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263691
- Sponsor's protocol ID
- EBS.AVA.201 / DMID 10-0013
- Other IDs
- HHSN272200800051C
- Status last verified
- Mar 2024
- First submitted
- 17 Dec 2010
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23701746
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-arm, Double-blind, Randomized, Placebo-controlled, Dose-ranging Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of AV7909 in Healthy Adults
- ClinicalTrials.gov ID
- NCT01263691
- Acronym / sponsor ID
- EBS.AVA.201 / DMID 10-0013
- Conditions
- Bacillus Anthracis (Anthrax) Infection
- Keywords
- AVA, AV7909, Anthrax vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Department of Health and Human Services
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BioThrax | Active comparator | Biological: BioThraxBioThrax, 0.5 mL AVA per dose |
| AV7909 Formulation 1 | Experimental | Biological: AV7909 Formulation 10.5 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose |
| AV7909 Formulation 2 | Experimental | Biological: AV7909 Formulation 20.5 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose |
| AV7909 Formulation 3 | Experimental | Biological: AV7909 Formulation 30.25 mL AVA + 0.5 mg CPG 7909 per 0.5 mL dose |
| AV7909 Formulation 4 | Experimental | Biological: AV7909 Formulation 40.25 mL AVA + 0.25 mg CPG 7909 per 0.5 mL dose |
| Control | Placebo comparator | Drug: ControlSaline control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be between 18 and 50 years of age, inclusive, at the time of enrollment.
- Be in good health as determined by the investigator from medical history and a physical examination.
- If a pre-menopausal female, must be using acceptable methods of birth control.
- Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
- Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc).
Key exclusion criteria (9 listed)
- A known anaphylactic response, severe systematic response, or serious hypersensitivity reaction to a prior immunization.
- Prior immunization with anthrax vaccine, recombinant Protective Antigen (rPA) vaccine, or known exposure to anthrax organisms.
- Have previously served in the military or plans to enlist in the military from Screening through Day 84.
- Have participated in anthrax therapeutic or vaccine trials (monoclonal anti-protective antigen (PA) or anthrax immune globulins or anthrax vaccines).
- Participation in any investigational clinical trial within 30 days preceding the Screening visit or planning to participate in a clinical trial requiring dosing through the Day 194 visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioThraxAlso: Anthrax Vaccine Adsorbed (AVA)BioThrax | Biological | BioThrax |
| AV7909 Formulation 1AV7909 Formulation 1 | Biological | AV7909 Formulation 1 |
| AV7909 Formulation 2AV7909 Formulation 2 | Biological | AV7909 Formulation 2 |
| AV7909 Formulation 3AV7909 Formulation 3 | Biological | AV7909 Formulation 3 |
| AV7909 Formulation 4AV7909 Formulation 4 | Biological | AV7909 Formulation 4 |
| ControlSaline control | Drug | Control |
Primary outcome
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Time frame: Days 0-6
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 Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0)
Time frame: Days 0-6
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
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Time frame: Days 14-20
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 Subjects With Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14)
Time frame: Days 14-20
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
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Time frame: Days 0-6
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 Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0)
Time frame: Days 0-6
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
Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Time frame: Days 14-20
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 Subjects With Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14)
Time frame: Days 14-20
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
Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Time frame: Days 0-56
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 Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events
Time frame: Days 0-56
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.
3 secondary outcomes
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.
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.
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.
Time frame: Day 0 (pre-dose), 7, 14 (pre-dose), 21, 28, 35, 42, 56, 70, and 84.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23701746Hopkins 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Bernton, MD study director
Emergent Biosolutions, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BioThrax, AV7909 Formulation 1 and AV7909 Formulation 2 in people with Bacillus Anthracis (Anthrax) Infection, run by Emergent BioSolutions at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) (time frame: Days 0-6). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.