ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03455309
Previous Study | Return to List | Next Study

Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03455309
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborators:
Infectious Diseases Clinical Research Program
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
NovaDigm Therapeutics, Inc.

Brief Summary:
The proposed study aims to further evaluate the safety and immunogenicity of a candidate S. aureus vaccine NDV-3A, as well as its efficacy against acquisition of S. aureus

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Biological: NDV-3A Biological: Placebo Phase 2

Detailed Description:
The investigators will conduct a Phase 2 clinical trial to evaluate the safety, immunogenicity, and efficacy of candidate vaccine NDV-3A (NovaDigm Therapeutics, Inc.) to prevent incident nasal acquisition of S. aureus among a population of military recruits at increased risk for S. aureus colonization and disease. Colonization is a risk factor for skin and soft tissue infection (SSTI), and the anterior nares is an important reservoir for S. aureus. Use of S. aureus nasal colonization (specifically, incident nasal colonization with S. aureus post-vaccination) as a primary endpoint will allow the investigators to pursue a statistically-valid and meaningful parameter related to S. aureus SSTI. The proposed trial may yield evidence to warrant evaluation of NDV-3A efficacy against SSTI in a large-scale, Phase 2/3 trial in this high risk population.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blind, placebo-controlled, randomized study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor, principal investigator and study site are all blinded but can access key if safety issues require unblinding
Primary Purpose: Prevention
Official Title: A Phase 2 Double-blind Placebo-controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing S. Aureus Colonization
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : November 21, 2018
Estimated Study Completion Date : February 21, 2019

Arm Intervention/treatment
Active Comparator: NDV-3A
0.5 mL dose containing 300 micrograms of recombinant Als3 protein in phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
Biological: NDV-3A
Single dose administered by intramuscular injection

Placebo Comparator: Placebo
0.5 mL dose containing phosphate-buffered saline and 0.5 mg aluminum as aluminum hydroxide
Biological: Placebo
Single dose administered by intramuscular injection




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 56 days post-vaccination ]
    Reduction in incident Staphylococcus aureus nasal colonization by study day 56 in a population of US Army trainees at Ft. Benning, GA


Secondary Outcome Measures :
  1. Evaluation of the efficacy of the NDV-3A vaccine [ Time Frame: 0-90 days ]
    Describe SSTI rates within the training company as defined by the development of skin and soft tissue infection (SSTI) over the training period as compared to other companies in the battalion as well as historical data

  2. Evaluation of the efficacy of the NDV-3A vaccine [ Time Frame: 0-90 days ]
    Describe NDV-3A-associated delay in time to first nasal acquisition of S. aureus colonization

  3. Evaluation of the efficacy of the NDV-3A vaccine [ Time Frame: 0-90 days ]
    Describe reduction in cross-sectional prevalence of S. aureus nasal/oral colonization

  4. Evaluation of safety and tolerability in all subjects [ Time Frame: 0-7 days ]
    Occurrence of solicited adverse events (AE) over a 7-day follow-up period following vaccination

  5. Evaluation of safety and tolerability in all subjects [ Time Frame: 0-28 days ]
    Occurrence of unsolicited AEs over a 28-day follow-up period following vaccination

  6. Evaluation of safety and tolerability in all subjects [ Time Frame: 0-90 days ]
    Occurrence of serious adverse events (SAE) or Adverse Events of Special Interest (AESI) at any time during the study period (enrollment to final in-person follow-up visit)

  7. Measurement and characterization of immunogenicity of NDV-3A [ Time Frame: 0-90 days ]
    Describe the humoral immune response induced by NDV-3A using ELISA analysis of serum

  8. Measurement and characterization of immunogenicity of NDV-3A [ Time Frame: 0-14 days ]
    Describe the cell mediated immune responses induced by NDV-3A using ELISpot analysis of PBMCs

  9. Describe the impact of NDV-3A on S. aureus acquisition and transmission [ Time Frame: 0-90 days ]
    Following determination of taxonomy (via sequencing of 16S rRNA), determine the relative abundance and distribution of, and change in, bacterial species colonizing the nose and throat (i.e. nasal/oral microbiome) of military trainees during the training period.

  10. Describe the impact of NDV-3A on S. aureus acquisition and transmission [ Time Frame: 0-90 days ]
    Compare the compositions of the nasal/oral microbiome between study groups to assess the impact of NDV-3A vaccine on the nasal/oral microbiome.

  11. Describe the impact of NDV-3A on S. aureus acquisition and transmission [ Time Frame: 0-90 days ]
    Utilize a combination of epidemiologic, microbiologic, and genomic data on colonization isolates to describe the intra-class transmission dynamics of S. aureus among congregate military trainees

  12. Describe the impact of NDV-3A on S. aureus acquisition and transmission [ Time Frame: 0-90 days ]
    Conduct whole genome sequencing on isolates to describe the intra- and inter-host concordance of infecting and colonizing strains of S. aureus



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active duty, male subject, 17-35 years of age, inclusive, at the time of screening.
  • Assigned to one of the selected companies/battalions
  • Informed of the nature of the study and has agreed to and is able to read, review, and sign the informed consent document prior to screening.
  • Free of known significant health problems as established by the requirements to be enrolled in a military training program before entering into the study.
  • Agrees to be reachable by phone, email or letter at 6 months post-vaccination.

Exclusion Criteria:

  • Reports receiving any investigational drug, investigational vaccine, or investigational device within 30 days prior to dosing; subjects will be allowed to receive routine vaccinations associated with training and any other prescribed medications not in the exclusion criteria.
  • Presence of clinically significant SSTI (e.g., cellulitis, abscess) at screening or other skin or skin structure infections that would confound the interpretation of clinical response.
  • Reports a history of allergic response(s), anaphylaxis, or other serious reactions to previous vaccinations.
  • Reports a history of allergies to yeast
  • Reports a history of anaphylaxis or other serious reactions to aluminum.
  • Reports a history of autoimmune disease (psoriasis, etc.)
  • Seropositive for HIV antibody.
  • Reports the use of any immunosuppressive drugs, including systemic corticosteroids (more than 14 days at a dose of >20 mg/day prednisone or equivalent), within 4 weeks prior to dosing.
  • Reports receiving any blood products within 3 months prior to dosing.
  • Reports donating blood/plasma within 28 days prior to dosing.
  • Illness causing temperature ≥ 100.4°F
  • Evidence of abnormal, unresolved laboratory results in the subject's medical record for the following tests: hemoglobin, white blood cell count, platelet count, creatinine, and alanine aminotransferase
  • Any other medical and/or social reason which, in the opinion of the investigator(s), would increase the subject's risk of having an adverse reaction as a result of participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455309


Contacts
Contact: John P Hennessey, PhD 2676405189 john_hennessey@novadigm.net
Contact: Michael Schwartz (704) 975-5057 mschwartz@novadigm.net

Locations
United States, Georgia
Fort Benning Recruiting
Fort Benning, Georgia, United States, 31905
Contact: Jason W Bennett, MD    301-295-2254    jason.bennett@usuhs.edu   
Contact: Patrick Carey, DO    762-408-2650    Patrick.m.carey.mil@mail.mil   
Sponsors and Collaborators
NovaDigm Therapeutics, Inc.
Infectious Diseases Clinical Research Program
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Jason W Bennett, MD USU IDCRP

Publications of Results:
Other Publications:
Responsible Party: NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03455309     History of Changes
Other Study ID Numbers: NDV3A-006
IDCRP-104 ( Other Identifier: IDCRP, USU )
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NovaDigm Therapeutics, Inc.:
Als3
SSTI
vaccine
NDV-3A
incident nasal colonization

Additional relevant MeSH terms:
Vaccines
Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents