Clinical Trial: A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax U

Brief Summary: The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.

Detailed Summary: The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.
Sponsor: Emergent BioSolutions

Current Primary Outcome:

  • Toxin Neutralizing Antibody (TNA) Level at Day 63 [ Time Frame: Day 63 ]
    Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold
  • Incidence of Adverse Events [ Time Frame: From the time of the first immunization on Day 0 through Day 84 ]
    Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84
  • Incidence of Serious Adverse Events [ Time Frame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination ]
    Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination
  • Incidence of Reactogenicity By Severity [ Time Frame: For 7 days following each vaccination on Days 0, 14, 28 ]

    Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.

    Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measuremen

    Original Primary Outcome:

    • Toxin Neutralizing Antibody (TNA) Level at Day 63 [ Time Frame: Day 63 ]
      Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold
    • Number of Adverse Events [ Time Frame: Up to 12 months ]
      Safety will be evaluated by adverse events, including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs.


    Current Secondary Outcome:

    • TNA Level at Day 42 [ Time Frame: Day 42 ]
      Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold
    • TNA Level at Day 28 [ Time Frame: Day 28 ]
      Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold
    • TNA Seroconversion Rate [ Time Frame: Up to Day 84 ]
      Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84


    Original Secondary Outcome: Same as current

    Information By: Emergent BioSolutions

    Dates:
    Date Received: January 16, 2013
    Date Started: January 2013
    Date Completion:
    Last Updated: February 6, 2015
    Last Verified: February 2015