Staphylococcus Aureus
Conditions
Keywords
Als3, SSTI, vaccine, NDV-3A, incident nasal colonization
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.
Interventions
BIOLOGICALNDV-3A
Single dose administered by intramuscular injection
BIOLOGICALPlacebo
Single dose administered by intramuscular injection
Sponsors
Infectious Diseases Clinical Research Program
Uniformed Services University of the Health Sciences
NovaDigm Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor, principal investigator and study site are all blinded but can access key if safety issues require unblinding
Intervention model description
double-blind, placebo-controlled, randomized study
Eligibility
Sex/Gender
MALE
Age
17 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevent acquisition of incident Staphylococcus aureus nasal colonization | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of the NDV-3A vaccine | 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 |
| Evaluation of safety and tolerability in all subjects | 0-7 days | Occurrence of solicited adverse events (AE) over a 7-day follow-up period following vaccination |
| Measurement and characterization of immunogenicity of NDV-3A | 0-90 days | Describe the humoral immune response induced by NDV-3A using ELISA analysis of serum |
| Describe the impact of NDV-3A on S. aureus acquisition and transmission | 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. |
Countries
United States
Outcome results
None listed