VELOCITY: An Anthrax Vaccine Clinical Study
Condition: Anthrax
MeSH terms: Anthrax
Intervention: AV7909; BioThrax
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3862.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anthrax; AV7909; BioThrax; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Vaccine; CPG 7909; Adjuvant

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent obtained from the participant (dated and signed).

          2. Healthy condition as established by medical history and clinical examination before
             entering into the study.

          3. A male or female aged 18 to 65 years, inclusive, at the time of informed consent.

          4. Body mass index (BMI) ≤35.0 kg/m^2 at Screening visit.

          5. Have adequate venous access for phlebotomies.

          6. For a woman of childbearing potential (WOCBP), negative serum pregnancy test at
             Screening and negative urine pregnancy test prevaccination on Day 1, not currently
             breastfeeding, and no intention to become pregnant during the study through Month 13.
             Every female participant is considered to be a WOCBP unless surgically sterile
             (bilateral oophorectomy or bilateral salpingectomy or hysterectomy) OR postmenopausal
             (defined as >12 consecutive months without menses and screening follicle-stimulating
             hormone >30 mIU/mL). Women who are not of childbearing potential are allowed to enroll
             if they are surgically sterile or postmenopausal as defined above.

        Exclusion Criteria:

          1. Use of any investigational or nonregistered product (drug, vaccine, device, or
             combination product) within 30 days preceding the dose of study vaccine, or planned
             use during the study through Month 13.

          2. Positive test result on urine drug screen, any evidence of ongoing drug abuse or
             dependence (including alcohol), or recent history (over the past five years) of
             treatment for alcohol or drug abuse.

          3. Chronic administration (defined as >14 days) of immunosuppressants or other
             immune-modifying drugs (includes oral or parenteral corticosteroids, for example, a
             glucocorticoid dose exceeding 10 mg/day prednisone or equivalent) within six months
             prior to the vaccine dose; inhalation use (for example, for seasonal allergies) is
             permitted.

          4. Planned administration of any commercially-available vaccine from seven days prior to
             the first study vaccination through two weeks after the last vaccination.

          5. Previous anaphylactic reaction, severe systemic response, or serious hypersensitivity
             to a prior immunization or a known allergy to synthetic Oligodeoxynucleotides,
             aluminum, formaldehyde, benzethonium chloride (phemerol), or latex.

          6. History of anthrax disease, suspected exposure to anthrax, or previous vaccination
             with any anthrax vaccine.

          7. Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area
             that may interfere with injection site assessments.

          8. A positive blood test for hepatitis B surface antigen, hepatitis C antibody, or human
             immunodeficiency virus (HIV) HIV-1 or HIV-2 antibodies.

          9. Any confirmed or suspected immunodeficiency condition (congenital or secondary) or
             autoimmune disease based on medical history and Physical Exam, for example,
             Guillain-Barré.

         10. A family history of congenital or hereditary immunodeficiency.

         11. Major congenital defects or serious chronic illness, including any cancer other than
             the following: a) any non-metastatic cancer (excluding hematologic malignancies) or
             melanoma of which the participant has been disease-free for at least five years and b)
             localized skin cancer, resected (including squamous cell and basal cell carcinomas).

         12. Acute disease at the time of enrollment. Note that screening lab tests may be delayed
             to allow the resolution of a transient acute condition or the subject may be
             rescreened.

         13. Any medical condition that, in the opinion of the investigator, could adversely impact
             the participant's participation or the conduct of the study.

         14. Any planned elective surgery during the study through 12 months after the last
             vaccination.

         15. Planned receipt of immunoglobulins and/or any blood products within the three months
             preceding study enrollment or at any point during the study period until after the
             final safety phone contact.

         16. Woman of childbearing potential refusing to practice an adequate method of
             contraception from at least one month before Day 1 and continuing through Month 13.

             An adequate method of contraception is defined as abstinence from sexual intercourse;
             prior bilateral tubal ligation; monogamous relationship with a vasectomized partner
             (vasectomy performed at least six months prior to the participant's screening visit);
             or any of these forms of birth control: pill, intrauterine device (IUD), implantable
             or injectable contraceptive (for example, Norplant® or Depo-Provera®), removable
             device (for example, NuvaRing® or Evra® patch), or double-barrier method (condom with
             spermicide, diaphragm with spermicide). The Principal Investigator and/or designee
             will discuss with the participant the need to use adequate contraception consistently
             and correctly and document such conversation in the participant's chart. In addition,
             the Principal Investigator and/or designee will instruct the participant to call
             immediately if the selected contraception method is discontinued or if pregnancy is
             known or suspected.

         17. Member or family member of the investigator site team.

         18. Previously served in the military any time after 1990 and/or plan to enlist in the
             military at any time from screening through the final telephone contact.