Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

NCT01447407 | Completed Phase 1 Results

• 1 other identifier: NDV3-002
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Staphylococcal Infections; Yeast Infections; Candidiasis

Keywords

Staphylococcal infections; Yeast infections; Candidiasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events

  The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.

  Up to 90 days post-vaccination

Secondary Outcomes (6)

• Immunogenicity - Serum Anti-Als3 IgG

  Baseline, Day 7, Day 14, Day 28, Day 90/Exit

• Immunogenicity - Serum Anti-Als3 IgA1

  Baseline, Day 7, Day 14, Day 28, Day 90/Exit

• Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG

  Baseline, Day 7, Day 14, Day 28, Day 90/Exit

• Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1

  Baseline, Day 7, Day 14, Day 28, Day 90/Exit

• Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)

  Baseline, Day 7, Day 14, Day 28, Day 90/Exit

Study Arms (4)

NDV-3 vaccine with alum IM

ACTIVE COMPARATOR

300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM

Biological: NDV-3 vaccine with alum IM

NDV-3 vaccine without alum IM

ACTIVE COMPARATOR

300 ug Als3 in PBS per dose, one dose administered IM

Biological: NDV-3 vaccine without alum IM

Placebo IM

PLACEBO COMPARATOR

0.5 mg Al as alum in PBS per dose, one dose administered IM

Biological: Placebo with alum IM

NDV-3 vaccine without alum ID

ACTIVE COMPARATOR

30 ug Als3 in PBS per dose, one dose administered ID

Biological: NDV-3 vaccine without alum ID

Interventions

NDV-3 vaccine with alum IM BIOLOGICAL

One dose administered IM

NDV-3 vaccine with alum IM

NDV-3 vaccine without alum IM BIOLOGICAL

One dose administered IM

NDV-3 vaccine without alum IM

Placebo with alum IM BIOLOGICAL

One dose administered ID

Placebo IM

NDV-3 vaccine without alum ID BIOLOGICAL

One dose administered ID

NDV-3 vaccine without alum ID

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 volunteer must have the ability to read and communicate in English.
• Completed the screening process (as described in this protocol) within 28 days prior to dosing.
• Healthy male and female volunteers 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 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.

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 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.
• Demonstrates a positive drug screen for non-prescription drugs.
• Reports a clinically significant illness during the 28 days prior to dosing (as determined by the Investigator\[s\]).
• 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 (eg, 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
• United States Department of Defense: collaborator

Study Sites (1)

Cetero Research Clinical Site

Fargo, North Dakota, 58104, United States

Location

Related Publications (1)

• Schmidt CS, White CJ, Ibrahim AS, Filler SG, Fu Y, Yeaman MR, Edwards JE Jr, Hennessey JP Jr. NDV-3, a recombinant alum-adjuvanted vaccine for Candida and Staphylococcus aureus, is safe and immunogenic in healthy adults. Vaccine. 2012 Dec 14;30(52):7594-600. doi: 10.1016/j.vaccine.2012.10.038. Epub 2012 Oct 22.

  PMID: 23099329 BACKGROUND

MeSH Terms

Conditions

Staphylococcal Infections; Candidiasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John P. Hennessey, Jr.
• Organization: NovaDigm Therapeutics, Inc.

john_hennessey@novadigm.net

12676405189

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 3, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 4, 2020
• Results First Posted: March 4, 2020

Record last verified: 2020-02

Locations

US (1)