search
Back to results

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

Primary Purpose

Staphylococcal Infections, Candidiasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NDV-3 investigational vaccine
Sponsored by
NovaDigm Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring NDV-3, vaccine, Staphylococcus aureus, MRSA, Candida

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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 subject must have the ability to read and communicate in English.
  2. Completed the screening process within 30 days prior to dosing.
  3. Healthy male and female subjects 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 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).

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 clinical 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. Reports a clinically significant illness during the 28 days prior to dosing (as determined by the clinical investigators).
  6. Demonstrates a positive drug screen for non-prescription drugs.
  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 (e.g., 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. Reports an intolerance of direct venipuncture.
  17. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study (females only).
  18. Demonstrates a positive pregnancy screen (females only).
  19. Any other medical and/or social (e.g. non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study.

    -

Sites / Locations

  • Cetero

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

Low Dose NDV-3 investigational vaccine

High Dose NDV-3 investigational vaccine

Arm Description

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

15 subjects will receive vaccine and 5 subjects will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Immune responses to NDV-3 investigational vaccine up to day 180 compared to baseline

Full Information

First Posted
January 7, 2011
Last Updated
May 21, 2012
Sponsor
NovaDigm Therapeutics, Inc.
Collaborators
Cetero Research, San Antonio, United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT01273922
Brief Title
Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida
Official Title
Phase I Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of NDV-3, a Recombinant Alum-Adjuvanted Vaccine for Staphylococcus Aureus and Candida Infections, Administered Intramuscular to Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NovaDigm Therapeutics, Inc.
Collaborators
Cetero Research, San Antonio, United States Department of Defense

4. Oversight

5. Study Description

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
Detailed Description
Preclinical studies in mice have established that several members of the Als family of proteins induce a protective immune response in mice and allow high survival rates following challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the NDV-3 investigational vaccine) is the most effective member of the Als protein family in protecting mice from challenge with either Candida or S. aureus. This Phase I study will evaluate the safety and immunogenicity of a two doses administered 6 months apart of NDV-3 vaccine at two dose levels. At least 40 subjects will be enrolled in the study in two groups of approximately 20 subjects each. Each group will be randomized so that 15 will receive NDV-3 vaccine and 5 will receive placebo. All injections will be administered intramuscularly. One group will receive a low dose of NDV-3 and the other a ten-fold higher dose. Subjects will have follow-up visits to assess the safety, tolerability and immune responses at days 3, 7, 14, 28, 90 and 180 after the first vaccination to compare to baseline levels and at days 7, 14 and 90 after the second vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Infections, Candidiasis
Keywords
NDV-3, vaccine, Staphylococcus aureus, MRSA, Candida

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose NDV-3 investigational vaccine
Arm Type
Placebo Comparator
Arm Description
15 subjects will receive vaccine and 5 subjects will receive placebo.
Arm Title
High Dose NDV-3 investigational vaccine
Arm Type
Placebo Comparator
Arm Description
15 subjects will receive vaccine and 5 subjects will receive placebo
Intervention Type
Biological
Intervention Name(s)
NDV-3 investigational vaccine
Intervention Description
Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly
Primary Outcome Measure Information:
Title
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.
Description
Clinical evaluations and safety laboratories
Time Frame
1 month
Secondary Outcome Measure Information:
Title
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.
Description
Immune responses to NDV-3 investigational vaccine up to day 180 compared to baseline
Time Frame
180 days post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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. Reports an intolerance of direct venipuncture. Pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study (females only). Demonstrates a positive pregnancy screen (females only). Any other medical and/or social (e.g. non-compliant) reason which, in the opinion of the investigator(s), would prevent participation in the study. -
Facility Information:
Facility Name
Cetero
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs