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NDV-3 investigational vaccine

Phase 1

Staphylococcal Infections | Monoclonal antibody | Other |United Therapeutics Corporation|Last Updated: May 22, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01273922Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and CandidaPHASE1 COMPLETED 40Jan 1, 2011Dec 1, 2011May 22, 20121 United States
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Study Endpoints
Primary Endpoints
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.
1 month

Clinical evaluations and safety laboratories

Secondary Endpoints
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.
180 days post-injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Low Dose NDV-3 investigational vaccinePLACEBO_COMPARATOR15 subjects will receive vaccine and 5 subjects will receive placebo.
High Dose NDV-3 investigational vaccinePLACEBO_COMPARATOR15 subjects will receive vaccine and 5 subjects will receive placebo
Interventions
NameTypeDescription
NDV-3 investigational vaccineBIOLOGICALTwo doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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