Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Public ClinicalTrials.gov record NCT01364571. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 18 to \<65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to \<65 years.
Study identification
- NCT ID
- NCT01364571
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 456 participants
Conditions and interventions
Conditions
Interventions
- SA4Ag vaccine low dose Biological
- Blood draw Procedure
- Colonization swab sample Procedure
- SA4Ag vaccine mid dose Biological
- Blood sample Procedure
- SA4Ag vaccine high dose Biological
- Placebo Biological
Biological · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- Aug 2011 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Jan 2013 (Actual)
- Last update posted
- Mar 4, 2019
2011 – 2013
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Broward Research Group | Hollywood | Florida | 33024 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | — |
| Prism Research | Saint Paul | Minnesota | 55114 | — |
| Buffalo Clinical Research Center, LLC | Buffalo | New York | 14202 | — |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45206 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | — |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
| Roberta Braun, M.D. | Austin | Texas | 78705 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
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 NCT01364571, 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 Mar 4, 2019 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01364571 live on ClinicalTrials.gov.