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

Last updated on November 10, 2019

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Study Location
Pfizer Investigational Site
Herston, Queensland, 4029 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections, Staphylococcal Vaccines, Active Immunotherapy, Staphylococcal Skin Infections, Staphylococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01018641
Pfizer
Completed
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

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Descriptive Information
Brief Title  ICMJE An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Bacterial Infections
  • Staphylococcal Vaccines
  • Immunotherapy, Active
  • Staphylococcal Skin Infections
  • Staphylococcal Infections
Intervention  ICMJE
  • 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 ?g of CP5 and CP8 and 20 ?g of rClfAm Mid-dose level 30 ?g of CP5 and CP8 and 60 ?g of rClfAm High dose level 100 ?g of CP5 and CP8 and 200 ?g 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.
  • 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 ?g of CP5 and CP8 and 20 ?g of rClfAm Mid-dose level 30 ?g of CP5 and CP8 and 60 ?g of rClfAm High dose level 100 ?g of CP5 and CP8 and 200 ?g of rClfAm

    In stage 2 the subject will receive one injection of 0.5 mL IM of the placebo.

  • 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.
  • 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 ?g of CP5 and CP8 and 20 ?g of rClfAm Mid-dose level 30 ?g of CP5 and CP8 and 60 ?g of rClfAm High dose level 100 ?g of CP5 and CP8 and 200 ?g of rClfAm

    In stage 2 the subject will receive no vaccine.

  • 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.

Study Arms  ICMJE
  • Experimental: 1
    SA3Ag in both stage 1 and stage 2
    Interventions:
    • Biological: SA3Ag vaccine
    • Procedure: Blood draw
    • Procedure: Colonization swab samples
  • Experimental: 2
    SA3Ag in stage 1 followed by placebo in stage 2.
    Interventions:
    • Biological: SA3Ag followed by Placebo
    • Procedure: Blood draw
    • Procedure: Colonization swab samples
  • Placebo Comparator: 3
    Placebo in both stage 1 and stage 2
    Interventions:
    • Biological: Placebo
    • Procedure: Blood draw
    • Procedure: Colonization swab samples
  • Experimental: 4
    SA3Ag in stage 1 and no vaccine in stage 2.
    Interventions:
    • Biological: SA3Ag with no booster in stage 2
    • Procedure: Blood draw
    • Procedure: Colonization swab samples
  • Placebo Comparator: 5
    Placebo in stage 1 and no vaccine in stage 2.
    Interventions:
    • Procedure: Placebo with no booster in stage 2
    • Procedure: Blood draw
    • Procedure: Colonization swab samples
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2011)
449
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2009)
408
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion DateJanuary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01018641
Other Study ID Numbers  ICMJE 6123K1-1007
B2251002
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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