Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
Condition: Staphylococcal Infections; Yeast Infections; Candidiasis
MeSH terms: Infections; Communicable Diseases; Candidiasis; Staphylococcal Infections
Intervention: NDV-3 vaccine with alum IM; NDV-3 vaccine without alum IM; Placebo with alum IM; NDV-3 vaccine without alum ID
Intervention description: One dose administered IM; One dose administered IM; One dose administered ID; One dose administered ID
Intervention MeSH terms: Vaccines; Aluminum sulfate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Staphylococcal infections; Yeast infections; Candidiasis

Summary:

      This partially-blind, placebo controlled study is a Phase 1b study using an investigational
      vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will
      compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose
      level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID)
      compared to placebo delivered ID.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed of the nature of the study and have agreed to and are able to read, review,
             and sign the informed consent document prior to screening. The informed consent
             document will be written in English, therefore the volunteer must have the ability to
             read and communicate in English.

          2. Completed the screening process (as described in this protocol) within 28 days prior
             to dosing.

          3. Healthy male and female volunteers 18-50 years of age, inclusive, at the time of
             dosing.

          4. No clinically significant deviation from normal as judged by the investigator(s) in
             the medical history, physical examination (including but may not be limited to an
             evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous
             systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory
             assessments, and by general observations.

          5. Female volunteers must be one of the following:

               -  of childbearing potential and practicing an acceptable method of birth control as
                  judged by the Investigator(s)

               -  naturally postmenopausal (no menses) for at least 1 year and has a documented FSH
                  level ≥ 40 mIU/mL

               -  surgically postmenopausal (bilateral oophorectomy or hysterectomy)

               -  sterile (surgically [bilateral tubal ligation] or the Essure® Procedure) Female
                  volunteers that are surgically sterile or surgically postmenopausal must provide
                  documentation of the bilateral tubal ligation, bilateral oophorectomy, or
                  hysterectomy prior to dosing or the volunteer must agree to use a medically
                  acceptable method of birth control. The Essure® Procedure must have been inserted
                  at least 3 months prior with documentation of the Essure® confirmation test prior
                  to Period I dosing. If the procedure was inserted less than 3 months prior to
                  Period I dosing or proper documentation of the confirmation test is not provided,
                  the volunteer must agree to use an additional medically acceptable method of
                  birth control.

        Exclusion Criteria:

          1. Reports receiving any investigational drug, investigational vaccine, or
             investigational device within 30 days prior to dosing.

          2. Reports any presence or history of a clinically significant disorder involving the
             cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
             endocrine, or neurologic system(s) or psychiatric disease as determined by the
             Investigator(s).

          3. Clinical laboratory test values outside the accepted range.

          4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B
             surface antigen, hepatitis C antibody, or HIV antibody.

          5. Demonstrates a positive drug screen for non-prescription drugs.

          6. Reports a clinically significant illness during the 28 days prior to dosing (as
             determined by the Investigator[s]).

          7. Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious
             reactions) to aluminum.

          8. Reports receiving any live attenuated vaccine including FluMist® within 6 weeks prior
             to dosing or any licensed inactivated vaccine within 3 weeks prior to dosing.

          9. Reports the use of any immunosuppressive drugs, including systemic corticosteroids,
             within 4 weeks prior to dosing.

         10. Reports the use of any medications or treatments that may alter immune responses to
             the study vaccine within 3 weeks prior to dosing (eg, cyclosporine, tacrolimus,
             cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal
             antibodies, radiation therapy).

         11. Reports a history of clinically significant allergies including food or drug allergies
             or anaphylaxis (or other serious reactions) to vaccines.

         12. Reports a history of drug or alcohol addiction or abuse within the past year.

         13. Reports receiving any blood products within 3 months prior to dosing and throughout
             the study.

         14. Reports donating blood within 28 days prior to dosing. All subjects will be advised
             not to donate blood for four weeks after completing the study.

         15. Reports donating plasma (e.g. plasmapheresis) within 14 days prior to dosing. All
             subjects will be advised not to donate plasma for four weeks after completing the
             study.

         16. Demonstrates, in the opinion of study staff, veins unsuitable for repeated
             venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a
             tendency to rupture during or after puncture).

         17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of
             the study.

         18. Demonstrates a positive pregnancy screen.

         19. Reports smoking or using tobacco products or is currently using nicotine products
             (patches, gums, etc). Thirty (30) days abstinence prior to dosing is required.

         20. Any other medical and/or social (e.g. uncooperative or non-compliant) reason which, in
             the opinion of the investigator(s), would prevent participation in the study.