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

Last updated on May 10, 2018

FOR MORE INFORMATION
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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An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Bacterial Infections
  • Staphylococcal Vaccines
  • Immunotherapy, Active
  • Staphylococcal Skin Infections
  • Staphylococcal Infections
  • 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.

  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
449
July 2011
January 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01018641
6123K1-1007
B2251002
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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