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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01018641
First received: November 20, 2009
Last updated: April 23, 2014
Last verified: April 2014

November 20, 2009
April 23, 2014
January 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Assessment of safety and tolerability as determined by local reactions, systemic events, and adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01018641 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Ig titers for each antigen 28 days after the booster dose. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s). [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Assessment of immunogenicity 1 month post-vaccination [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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.
  • 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.

  • 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 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.

  • 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
Not Provided

*   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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01018641
6123K1-1007, B2251002
Yes
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