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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT01364571•Pfizer

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adults aged 18 to \<65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
•Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
•Ability to be contacted by telephone during study participation.
•All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.

Exclusion Criteria

•Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
•Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
•Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
•Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through 1 month post-vaccination.
•Any contraindication to vaccination or vaccine components.
•Immunocompromised persons and subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents or long term systemic corticosteroids.
•Previous administration of S. aureus vaccination.
•Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination.
•Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
•Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation.
+5 more criteria

Locations (16)

Broward Research Group

Hollywood, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, United States

Prism Research

Saint Paul, Minnesota, United States

Buffalo Clinical Research Center, LLC

Buffalo, New York, United States

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

January 1, 2013

Last Updated

March 4, 2019

Enrollment

456

ACTUAL participants

Conditions

Staphylococcal Infections

Interventions

SA4Ag vaccine low dose

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

SA4Ag vaccine mid dose

BIOLOGICAL

Blood sample

PROCEDURE

Colonization swab sample

PROCEDURE

SA4Ag vaccine high dose

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

Placebo

BIOLOGICAL

Blood draw

PROCEDURE

Colonization swab sample

PROCEDURE

Unbound Cloxacillin Concentrations During Continuous Infusion

NCT06848387

Staphylococcal Infections

View study

RECRUITINGPHASE4

Adjunctive Clindamycin for the Treatment of Skin and Soft Tissue Infections, a Randomized Controlled Trial

NCT05899140

Skin InfectionStaphylococcal Infections+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Unbound Cloxacillin Concentrations During Continuous Infusion

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