Phase 1
N=105
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Bacillus Anthracis (Anthrax) Infection
Bottom Line
View on ClinicalTrials.gov: NCT01263691 ↗Enrolled (actual)
105
Serious AEs
2.9%
Results posted
Aug 2014
Primary outcome: Primary: Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) — 11; 17; 13; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BioThrax (Biological); AV7909 Formulation 1 (Biological); AV7909 Formulation 2 (Biological); AV7909 Formulation 3 (Biological); AV7909 Formulation 4 (Biological); Control (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emergent BioSolutions
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) |
11; 17; 13; 12; 16; 1 | — |
| 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) |
61.1; 94.4; 76.5; 63.2; 88.9; 6.7 | — |
| PRIMARY Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Vaccination (Day 14) |
11; 16; 12; 11; 13; 0 | — |
| 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) |
61.1; 88.9; 70.6; 57.9; 72.2; 0 | — |
| PRIMARY Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Injection (Day 0) |
10; 12; 7; 3; 7; 5 | — |
| 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) |
55.6; 66.7; 41.2; 15.8; 38.9; 33.3 | — |
| PRIMARY Incidence of Systemic Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the Second Injection (Day 14) |
7; 14; 7; 4; 9; 2 | — |
| 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) |
38.9; 77.8; 41.2; 21.1; 50.0; 13.3 | — |
| PRIMARY Incidence of Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events |
0; 0; 1; 0; 1; 1 | — |
| PRIMARY Percentage of Subjects With Hematology, Serum Chemistry, and Urinalysis Abnormalities Reported as Adverse Events |
0; 0; 5.9; 0; 5.6; 6.7 | — |
| 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. |
0.15; 3.40; 4.02; 2.81; 1.93; 0.04 | — |
| 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. |
28.0; 29.0; 28.0; 28.5; 29.0; 7.0 | — |
| SECONDARY TNA NF50 GMTs Across Study Days After IM Administration of Investigational Product on Days 0 and 14. |
0.03; 0.03; 0.03; 0.03; 0.03; 0.03 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
Key Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01263691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.