NCT01447407

Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine

Phase 1b Study to Evaluate the Safety and Immunogenicity of NDV-3 Formulated With or Without Alum (AlOH) and Administered Either Intramuscular (IM) or Intradermally (ID) to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: NovaDigm Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.

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. The first Phase 1 study enrolled 40 healthy subjects that received placebo (N=10), 1 dose (N=30) or 2 doses (N=19) of the NDV-3 vaccine administered intramuscularly (IM). The vaccine was well tolerated and highly immunogenic. This study will evaluate the safety, tolerability and immunogenicity of one dose of NDV-3 vaccine formulated with and without alum given IM and also a lower dose without alum given intradermally (ID). Subjects will have follow-up visits to assess the safety tolerability and immune responses at selected time points up to 90 days post-vaccination.

Conditions

• Staphylococcal Infections
• Yeast Infections
• Candidiasis

Interventions

Type	Name	Description
BIOLOGICAL	NDV-3 vaccine with alum IM	One dose administered IM
BIOLOGICAL	NDV-3 vaccine without alum IM	One dose administered IM
BIOLOGICAL	Placebo with alum IM	One dose administered ID
BIOLOGICAL	NDV-3 vaccine without alum ID	One dose administered ID

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-03-01
• Completion: 2012-12-01
• First posted: 2011-10-06
• Last updated: 2020-03-04
• Results posted: 2020-03-04

Locations

1 site across 1 country: United States