NCT01018641

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

November 20, 2009

Last Update Submit

April 23, 2014

Conditions

Bacterial InfectionsStaphylococcal VaccinesImmunotherapy, ActiveStaphylococcal Skin InfectionsStaphylococcal Infections

Keywords

Staphylococcus aureusVaccine

Outcome Measures

Primary Outcomes (2)

  • 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).

    1 month

  • The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.

    1 month

Secondary Outcomes (4)

  • 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.

    1 month

  • Ig titers for each antigen 28 days after the booster dose.

    7 months

  • The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.

    12 months

  • OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).

    1 month

Study Arms (5)

1

EXPERIMENTAL

SA3Ag in both stage 1 and stage 2

Biological: SA3Ag vaccineProcedure: Blood drawProcedure: Colonization swab samples

2

EXPERIMENTAL

SA3Ag in stage 1 followed by placebo in stage 2.

Biological: SA3Ag followed by PlaceboProcedure: Blood drawProcedure: Colonization swab samples

3

PLACEBO COMPARATOR

Placebo in both stage 1 and stage 2

Biological: PlaceboProcedure: Blood drawProcedure: Colonization swab samples

4

EXPERIMENTAL

SA3Ag in stage 1 and no vaccine in stage 2.

Biological: SA3Ag with no booster in stage 2Procedure: Blood drawProcedure: Colonization swab samples

5

PLACEBO COMPARATOR

Placebo in stage 1 and no vaccine in stage 2.

Procedure: Placebo with no booster in stage 2Procedure: Blood drawProcedure: Colonization swab samples

Interventions

SA3Ag vaccineBIOLOGICAL

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.

1
Blood drawPROCEDURE

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.

1
Colonization swab samplesPROCEDURE

Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

1
SA3Ag followed by PlaceboBIOLOGICAL

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.

2
PlaceboBIOLOGICAL

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.

3
SA3Ag with no booster in stage 2BIOLOGICAL

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.

4
Placebo with no booster in stage 2PROCEDURE

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.

5

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Herston, Queensland, 4029, Australia

Location

Pfizer Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Pfizer Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

Pfizer Investigational Site

Prahran, Victoria, 3004, Australia

Location

Pfizer Investigational Site

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (2)

  • Marshall H, Nissen M, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber WC, Jansen KU, Anderson AS, Zito ET, Girgenti D. Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study. J Infect. 2016 Nov;73(5):437-454. doi: 10.1016/j.jinf.2016.08.004. Epub 2016 Aug 9.

    PMID: 27519620DERIVED

  • Nissen M, Marshall H, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber W, Jansen KU, Emini EA, Anderson AS, Zito ET, Girgenti D. A randomized phase I study of the safety and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults. Vaccine. 2015 Apr 8;33(15):1846-54. doi: 10.1016/j.vaccine.2015.02.024. Epub 2015 Feb 21.

    PMID: 25707693DERIVED

Related Links

MeSH Terms

Conditions

Bacterial InfectionsMotor ActivityStaphylococcal Skin InfectionsStaphylococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBehaviorGram-Positive Bacterial InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

July 1, 2011

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

AU(5)