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NDV-3 investigational vaccine · 1 trial · 2 indications
Clinical evaluations and safety laboratories
| Arm | Type | Description |
|---|---|---|
| Low Dose NDV-3 investigational vaccine | PLACEBO_COMPARATOR | 15 subjects will receive vaccine and 5 subjects will receive placebo. |
| High Dose NDV-3 investigational vaccine | PLACEBO_COMPARATOR | 15 subjects will receive vaccine and 5 subjects will receive placebo |
| Name | Type | Description |
|---|---|---|
| NDV-3 investigational vaccine | BIOLOGICAL | Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly |
Inclusion Criteria: 1. Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the subject must have the ability to read and communicate in Eng...
NDV-3 is an investigational vaccine being developed for the prevention of staphylococcal infections, including those caused by Staphylococcus aureus. It is also being studied for its potential use against candidiasis, a fungal infection. The vaccine is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.
NDV-3 is a recombinant protein vaccine designed to elicit an immune response against Staphylococcus aureus and Candida species. It contains a recombinant protein that mimics a surface protein found on these pathogens, stimulating the production of antibodies that can neutralize the microbes and prevent infection.
NDV-3 is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine in healthy volunteers.
NDV-3 is currently in Phase 1 clinical development. A Phase 1 clinical trial has been completed to assess the safety and immunogenicity of the vaccine. As an investigational product, it has not yet received approval from the U.S. Food and Drug Administration (FDA) or other regulatory agencies.
NDV-3 has been evaluated in a Phase 1 clinical trial registered as NCT01273922, titled 'Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida.' This randomized, double-blind, placebo-controlled study enrolled 40 participants in the United States and has been completed.