Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emergent BioSolutions
• Collaborators: Department of Health and Human Services; National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Vaccines

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.