NCT03455309

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

A Phase 2 Double-blind Placebo-controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing S. Aureus Colonization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: NovaDigm Therapeutics, Inc. · Industry
• Sex: Male
• Age: 17 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Staphylococcus Aureus

Interventions

Type	Name	Description
BIOLOGICAL	NDV-3A	Single dose administered by intramuscular injection
BIOLOGICAL	Placebo	Single dose administered by intramuscular injection

Timeline

• Start date: 2018-01-30
• Primary completion: 2019-07-19
• Completion: 2019-10-15
• First posted: 2018-03-06
• Last updated: 2020-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study