NCT01273922

Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida

Phase I Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Immunogenicity of NDV-3, a Recombinant Alum-Adjuvanted Vaccine for Staphylococcus Aureus and Candida Infections, Administered Intramuscular to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NovaDigm Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study using two dose levels of an investigational vaccine directed against S. aureus and Candida. The study is designed to evaluate the safety, tolerability and immunogenicity of the investigational vaccine, NDV-3

Detailed description

Preclinical studies in mice have established that several members of the Als family of proteins induce a protective immune response in mice and allow high survival rates following challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the NDV-3 investigational vaccine) is the most effective member of the Als protein family in protecting mice from challenge with either Candida or S. aureus. This Phase I study will evaluate the safety and immunogenicity of a two doses administered 6 months apart of NDV-3 vaccine at two dose levels. At least 40 subjects will be enrolled in the study in two groups of approximately 20 subjects each. Each group will be randomized so that 15 will receive NDV-3 vaccine and 5 will receive placebo. All injections will be administered intramuscularly. One group will receive a low dose of NDV-3 and the other a ten-fold higher dose. Subjects will have follow-up visits to assess the safety, tolerability and immune responses at days 3, 7, 14, 28, 90 and 180 after the first vaccination to compare to baseline levels and at days 7, 14 and 90 after the second vaccination.

Conditions

• Staphylococcal Infections
• Candidiasis

Interventions

Type	Name	Description
BIOLOGICAL	NDV-3 investigational vaccine	Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2011-01-11
• Last updated: 2012-05-22

Locations

1 site across 1 country: United States