Safety and Immunogenicity Study of Recombinant Ricin Toxin A-Chain Vaccine (RVEc™)
Condition: Ricin
Intervention: RVEc
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Ricin; RVEc

Summary:

      This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the
      safety and immunogenicity of the RVEc vaccine.

      The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety
      profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin
      G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA)
      anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine
      recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects must be 18-50 years old.

          -  Subjects must weigh at least 110 pounds.

          -  Subjects must be in good health as judged from medical history, physical examination,
             EKG and chest x-ray, complete blood count (CBC) with differential, clinical
             chemistries, urinalysis, hepatitis serology, and HIV antibody test, and be medically
             cleared for participation by an investigator. If any HIV or hepatitis testing is
             positive, the individual will be provided with counseling and referral for health
             care.

          -  Females of childbearing potential must have a negative pregnancy test on vaccination
             day before each dose and agree to not become pregnant or breastfeed for 3 months after
             the last dose of the vaccine and be willing to use a reliable form of contraception
             during the study.

          -  Study subjects must read and sign an approved informed consent.

          -  Study subjects must be willing to complete a subject diary card after each
             vaccination.

          -  Study subjects must be willing to return for all follow-up visits.

          -  Study subjects must agree to report any adverse event (AE) that may or may not be
             associated with administration of the investigational product through the 9-month
             follow-up visit. Study subjects will report all serious adverse events for the
             duration of the study.

        Exclusion Criteria:

          -  Body weight less than 110 pounds.

          -  Acute or chronic medical conditions or immunodeficiency from a medical condition or
             medical treatment, medications, or dietary supplements that, in the investigator's
             opinion, would impair the subject's ability to respond to vaccination.

          -  Severe hypersensitivity to any vaccine (anaphylaxis, angioedema, bronchospasm, or
             laryngospasm).

          -  History of asthma, chronic obstructive pulmonary disease, or other current/residual
             disease of the lungs.

          -  Clinically significant abnormal laboratory tests.

          -  Current smoker.

          -  Any known allergies to sodium succinate, Tween-20 (a detergent), aluminum hydroxide,
             or kanamycin.

          -  Previously received ricin toxin vaccine or has antibodies to ricin toxin proteins.

          -  Receipt of licensed vaccines within 30 days prior to the start of the study or plans
             to receive other vaccines during the initial 9 months of the study (the only
             exceptions are the inactivated influenza vaccine that can be received at least 30 days
             after RVEc Dose 3).

          -  Receipt of investigational drug/test product within 30 days prior to entry or within
             the initial 9 months of the study.

          -  Females: Pregnant or breastfeeding.

          -  Enrolled in another greater than minimal risk study.