Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida
| Status: | Archived |
|---|---|
| Conditions: | Menses Disorders, Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2011 |
| End Date: | December 2011 |
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
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
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 single dose 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 vaccination to compare to baseline levels.
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