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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly
Cetero
Fargo, North Dakota, United States
The primary objective of this study is to assess the safety and tolerability of one dose of NDV-3 vaccine compared to placebo at two different dose levels.
Clinical evaluations and safety laboratories
Time frame: 1 month
The secondary objective is to compare the humoral and cellular immune responses between the two dose levels compared to placebo at several time points over a 6 month period.
Immune responses to NDV-3 investigational vaccine up to day 180 compared to baseline
Time frame: 180 days post-injection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.