VELOCITY: An Anthrax Vaccine Clinical Study
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the lot consistency (using three consecutively
      manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune
      response in healthy adults and compare the response to that induced by the currently licensed
      vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.
    

Detailed description: 
      This is a Phase 3, multicenter, randomized, double-blind, parallel-group trial designed to
      evaluate the lot consistency (using three consecutively manufactured lots), immunogenicity,
      and safety of AV7909 administered in healthy adults for an indication of postexposure
      prophylaxis (PEP) of anthrax.

      Healthy adults between 18 and 65 years of age (inclusive) will sign and date an informed
      consent form and then be screened for eligibility for participation in the study 2 to 28 days
      prior to randomization. Participants meeting the entry criteria will be randomized 2:2:2:1 to
      one of four study groups on Day 1. Randomization will be stratified by site.

      Participants will be evaluated for safety through Day 64 [or the early withdrawal visit
      (EWV)], as assessed by clinical laboratory tests (hematology, serum chemistry, and
      urinalysis), monitoring of Adverse Events (AE) including Serious Adverse Events (SAE) and
      Adverse Events of Special Interest (AESI), vital signs, and physical examinations. Adverse
      Events of Special Interest are adverse events associated with autoimmune disease as defined
      by the Center for Biologics Evaluation and Research, and might represent a safety signal for
      vaccine-associated autoimmunity. Reactogenicity (solicited systemic and injection site
      reactions) will be assessed daily by the participants using electronic diaries (e-diaries)
      after each vaccination.

      Information on the use of medications will be collected at each study visit. In addition,
      blood samples for auto-antibody assessment will be taken at Day 1 predose and Day 64 (or
      Early Withdrawal Visit).

      Participants who receive at least one dose of vaccine but who for any reason discontinue
      vaccinations prematurely will be asked to participate in the further planned study visits up
      to Day 64 for safety assessment only.

      Participants who receive at least one dose of vaccine will also be asked to participate in
      safety follow-up phone calls occurring on Day 43, Month 4, Month 7, Month 10, and Month 13
      (nominally 0.5, 3, 6, 9, and 12 months after the last vaccination) to collect information on
      AEs, SAEs and any potential AESIs. Based on responses at these phone contacts, participants
      may be asked to return to the clinic for an unscheduled visit to provide blood samples for
      auto-antibody testing to investigate reports of potential AESIs.

      Independent safety oversight will be provided by a Data Safety Monitoring Board, which will
      be notified of significant AEs as determined by the Medical Monitor on an ongoing basis.
    

Intervention name(s): AV7909; BioThrax
Intervention type(s): Biological; Biological
Intervention description(s): AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. BioThrax is licensed for post-exposure prophylaxis of anthrax disease. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.; BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anthrax; AV7909; BioThrax; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Vaccine; CPG 7909; Adjuvant