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

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Staphylococcus Aureus

Clinical Trial Details

NCT number	NCT03455309
Study type	Interventional
Source	NovaDigm Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	January 30, 2018
Completion date	October 15, 2019

View Details

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