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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01273922

Public ClinicalTrials.gov record NCT01273922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 2:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01273922
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
NovaDigm Therapeutics, Inc.
Industry
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2010
Primary completion
Sep 30, 2011
Completion
Nov 30, 2011
Last update posted
May 21, 2012

2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cetero Fargo North Dakota 58104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01273922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 21, 2012 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01273922 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →