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Trial record 1 of 1 for:    NCT03455309
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Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization

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ClinicalTrials.gov Identifier: NCT03455309
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : January 29, 2020
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 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
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : October 15, 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. Prevent acquisition of incident Staphylococcus aureus nasal colonization [ Time Frame: 56 days post-vaccination ]
    Change 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

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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


Locations
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United States, Georgia
Fort Benning
Fort Benning, Georgia, United States, 31905
Sponsors and Collaborators
NovaDigm Therapeutics, Inc.
Infectious Diseases Clinical Research Program
Uniformed Services University of the Health Sciences
Investigators
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Principal Investigator: Jason W Bennett, MD USU IDCRP
Publications of Results:
Other Publications:
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Responsible Party: NovaDigm Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03455309    
Other Study ID Numbers: NDV3A-006
IDCRP-104 ( Other Identifier: IDCRP, USU )
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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