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Phase 1b Partially-blind,Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of NDV-3, A Recombinant Alum Adjuvanted Vaccine for S. Aureus and Candida Infections, Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults

This study is currently Recruiting

October 2011 By NovaDigm Therapeutics, Inc.

First Recieved on October 3, 2011

Last Updated on October 4, 2011

Sponsor: NovaDigm Therapeutics, Inc.
Collaborators: Department of Defense
Information provided by: NovaDigm Therapeutics, Inc.
Identifier: NCT01447407

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
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.

Investigators

Locations

  • Cetero Research Clinical Site

    Fargo, North Dakota 58104 United States

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