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NCT01273922 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida

A Phase 1 study, sponsored by NovaDigm Therapeutics.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT01273922: Completed Phase 1 study, sponsored by NovaDigm Therapeutics.

NCT01273922 is a Phase 1 study that has completed, run by NovaDigm Therapeutics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01273922, a Phase 1 study, has completed, sponsored by NovaDigm Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

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

Primary Outcome

Clinical evaluations and safety laboratories

Interventions

  • BIOLOGICAL NDV-3 investigational vaccine

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2011-01
Est. Completion 2011-12
Phase Phase 1
NovaDigm Therapeutics

4 total trials

What the finished NCT01273922 record still lists

NCT01273922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 1 intervention - of which NDV-3 investigational vaccine is the first listed.

NCT01273922 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01273922 about?

NCT01273922 is a clinical study titled "Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida". 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

What is the current status of trial NCT01273922?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2011-01. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01273922?

The interventions under investigation include: NDV-3 investigational vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01273922?

This trial is sponsored by NovaDigm Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01273922's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01273922, the US trial registry maintained by the National Library of Medicine. NCT01273922 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.