Clinical trial NCT03455309: Evaluation of NDV-3A Vaccine in Preventing S. Aureus Colonization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Staphylococcus Aureus
Keywords: Als3
SSTI
vaccine
NDV-3A
incident nasal colonization
Lead sponsor: NovaDigm Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Infectious Diseases Clinical Research Program
name: Uniformed Services University of the Health Sciences
First posted: 2018-03-06
Enrollment: 382
Sex: MALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind, placebo-controlled, randomized study
Primary purpose: PREVENTION

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

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.

Eligibility 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.

Primary outcomes:
measure: Prevent acquisition of incident Staphylococcus aureus nasal colonization
timeFrame: 56 days post-vaccination
Secondary outcomes:
measure: Evaluation of the efficacy of the NDV-3A vaccine
timeFrame: 0-90 days
measure: Evaluation of the efficacy of the NDV-3A vaccine
timeFrame: 0-90 days
measure: Evaluation of the efficacy of the NDV-3A vaccine
timeFrame: 0-90 days
measure: Evaluation of safety and tolerability in all subjects
timeFrame: 0-7 days
measure: Evaluation of safety and tolerability in all subjects
timeFrame: 0-28 days
measure: Evaluation of safety and tolerability in all subjects
timeFrame: 0-90 days
measure: Measurement and characterization of immunogenicity of NDV-3A
timeFrame: 0-90 days
measure: Measurement and characterization of immunogenicity of NDV-3A
timeFrame: 0-14 days
measure: Describe the impact of NDV-3A on S. aureus acquisition and transmission
timeFrame: 0-90 days
measure: Describe the impact of NDV-3A on S. aureus acquisition and transmission
timeFrame: 0-90 days
measure: Describe the impact of NDV-3A on S. aureus acquisition and transmission
timeFrame: 0-90 days
measure: Describe the impact of NDV-3A on S. aureus acquisition and transmission
timeFrame: 0-90 days
Other outcomes:
Locations:
city: Fort Benning
country: United States
facility: Fort Benning
state: Georgia
Study officials:
affiliation: USU IDCRP
name: Jason W Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeaman MR, Filler SG, Chaili S, Barr K, Wang H, Kupferwasser D, Hennessey JP Jr, Fu Y, Schmidt CS, Edwards JE Jr, Xiong YQ, Ibrahim AS. Mechanisms of NDV-3 vaccine efficacy in MRSA skin versus invasive infection. Proc Natl Acad Sci U S A. 2014 Dec 23;111(51):E5555-63. doi: 10.1073/pnas.1415610111. Epub 2014 Dec 8.
citation: 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.