Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida

NCT01273922 | Completed Phase 1

• 1 other identifier: NDV-3-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study using two dose levels of an investigational vaccine directed against S. aureus and Candida. The study is designed to evaluate the safety, tolerability and immunogenicity of the investigational vaccine, NDV-3

Conditions

Staphylococcal Infections; Candidiasis

Keywords

NDV-3; vaccine; Staphylococcus aureus; MRSA; Candida

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to assess the safety and tolerability of one dose of NDV-3 vaccine compared to placebo at two different dose levels.

  Clinical evaluations and safety laboratories

  1 month

Secondary Outcomes (1)

• The secondary objective is to compare the humoral and cellular immune responses between the two dose levels compared to placebo at several time points over a 6 month period.

  180 days post-injection

Study Arms (2)

Low Dose NDV-3 investigational vaccine

PLACEBO COMPARATOR

15 subjects will receive vaccine and 5 subjects will receive placebo.

Biological: NDV-3 investigational vaccine

High Dose NDV-3 investigational vaccine

PLACEBO COMPARATOR

15 subjects will receive vaccine and 5 subjects will receive placebo

Biological: NDV-3 investigational vaccine

Interventions

NDV-3 investigational vaccine BIOLOGICAL

Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly

High Dose NDV-3 investigational vaccine; Low Dose NDV-3 investigational vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 subject must have the ability to read and communicate in English.
• Completed the screening process within 30 days prior to dosing.
• Healthy male and female subjects 18-50 years of age, inclusive, at the time of dosing.
• 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.
• Female subjects must be:
• of childbearing potential and practicing an acceptable method of birth control described below as judged by the investigator(s); or
• of postmenopausal status (no menses) for at least 1 year and has a documented FSH level ≥ 40 mIU/mL; or
• sterile (surgically \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\] or the Essure® Procedure).

You may not qualify if:

• Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing.
• 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 clinical investigator(s).
• Clinical laboratory test values outside the accepted range.
• When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• Reports a clinically significant illness during the 28 days prior to dosing (as determined by the clinical investigators).
• Demonstrates a positive drug screen for non-prescription drugs.
• Reports a history of allergic response(s) to nickel or anaphylaxis (or other serious reactions) to aluminum.
• 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.
• Reports the use of any immunosuppressive drugs, including systemic corticosteroids, within 4 weeks prior to dosing.
• Reports the use of any medications or treatments that may alter immune responses to the study vaccine within 3 weeks prior to dosing (e.g., cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin \[BCG\], monoclonal antibodies, radiation therapy).
• Reports a history of clinically significant allergies including food or drug allergies or anaphylaxis (or other serious reactions) to vaccines.
• Reports a history of drug or alcohol addiction or abuse within the past year.
• Reports receiving any blood products within 3 months prior to dosing and throughout the study.
• 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.
• 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.

Sponsors & Collaborators

• NovaDigm Therapeutics, Inc.: lead
• Cetero Research, San Antonio: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Cetero

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Candidiasis; Torulopsis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Mycoses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 11, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

US (1)