An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

April 23, 2014 updated by: Pfizer

A Phase 1 Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

This study is a first-in-human (Phase 1) study using three dose levels of an investigational vaccine directed against Staphylococcus aureus (SA3Ag). This study is primarily designed to assess how safe and well tolerated SA3Ag is, but will also describe the immune response over 12 months elicited by SA3Ag. Additionally, this study will assess the effect of SA3Ag vaccine on the number of Staphylococcus aureus bacteria that naturally occur on the skin and within the nose and throat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Pfizer Investigational Site
      • North Adelaide, South Australia, Australia, 5006
        • Pfizer Investigational Site
    • Victoria
      • Prahran, Victoria, Australia, 3004
        • Pfizer Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged 18 to 24 years or 50 to 85 years who are available for the entire duration of the study, able to be contacted by phone, and able to complete all study procedures, including completion of an electronic diary (e-diary).
  • Men and women who are able to have children, must use a reliable method of birth control for the duration of the study.

Exclusion Criteria:

  • Any major illness that would substantially increase the risk associated with participation in the study, or interfere with the evaluation of the study objectives - this is determined by the local physician.
  • Donation of 250 mL or more of blood within the last 3 months.
  • Condition associated with prolonged bleeding time, including subjects taking anticoagulant medication or antiplatelet therapy.
  • Any contraindication to vaccination or vaccine components.
  • Immunocompromised persons and subjects who receive treatment with immunosuppressive therapy.
  • Previous administration of S. aureus vaccination.
  • Receipt of blood products or immunoglobulins within 12 months prior to study
  • Participation in another trial (not including observational trials) within the last 30 days.
  • Study site personnel or immediate family members (first-degree relatives).
  • Women who are pregnant (as determined by urine pregnancy test) or breast-feeding.
  • Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care.
  • For subjects aged 65 years or older, a Mini-Mental State Examination (MMSE) score of <=21.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
SA3Ag in both stage 1 and stage 2
Biological: SA3Ag vaccine

In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:

Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm

In stage 2 the subject will receive 0.5 mL IM of the same dose level he/she received in stage 1.

Procedure: Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Procedure: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
EXPERIMENTAL: 2
SA3Ag in stage 1 followed by placebo in stage 2.
Procedure: Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Procedure: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Biological: SA3Ag followed by Placebo

In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:

Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm

In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.
PLACEBO_COMPARATOR: 3
Placebo in both stage 1 and stage 2
Procedure: Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Procedure: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Biological: Placebo
In both stage 1 and stage 2, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl for a total of 2 injections throughout the study.
EXPERIMENTAL: 4
SA3Ag in stage 1 and no vaccine in stage 2.
Procedure: Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Procedure: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Biological: SA3Ag with no booster in stage 2

In stage 1, each subject will receive 1 injection (0.5 mL) of one of the following doses:

Low dose level 10 μg of CP5 and CP8 and 20 μg of rClfAm Mid-dose level 30 μg of CP5 and CP8 and 60 μg of rClfAm High dose level 100 μg of CP5 and CP8 and 200 μg of rClfAm

In stage 2 the subject will receive no vaccine.
PLACEBO_COMPARATOR: 5
Placebo in stage 1 and no vaccine in stage 2.
Procedure: Blood draw
Blood for immunogenicity will be taken at timepoints throughout stage 1 and stage 2. Blood for hematology will be done in a select subset of subjects in stage 1.
Procedure: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Procedure: Placebo with no booster in stage 2

In stage 1, recipients will receive one injection (0.5 mL) IM of 150 mM (isotonic) NaCl.

In stage 2 the subject will receive no vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary immunogenicity endpoint in stage 1 is antigen-specific antibody levels using an Ig binding assay (Ig titers) 28 days after vaccination at visit 1 in the 50- to 85-year age stratum at each vaccine group (3 SA3Ag dose levels and placebo).
Time Frame: 1 month
1 month
The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary immunogenicity endpoints are Ig titers for each antigen (CP5, CP8, and rClfAm) 28 days after vaccination in the 18- to 24-year age stratum at each dose level cohort.
Time Frame: 1 month
1 month
Ig titers for each antigen 28 days after the booster dose.
Time Frame: 7 months
7 months
The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.
Time Frame: 12 months
12 months
OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (ESTIMATE)

November 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6123K1-1007
  • B2251002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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