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Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years

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ClinicalTrials.gov Identifier: NCT01643941
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 18, 2012
Last Update Posted Date March 4, 2019
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • Number and proportion of subjects reporting solicited local reactions (size of redness and/or swelling and severity of pain at the injection site) and severity of the local reactions as self-reported on electronic diaries (e-diaries) [ Time Frame: 14 days ]
  • Number and proportion of subjects reporting solicited systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain) and severity of solicited systemic events self-reported on electronic diaries [ Time Frame: 14 days ]
  • Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) [ Time Frame: 1 month (AEs); 6 months (SAEs) ]
  • Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments [ Time Frame: 14 days ]
  • Number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments [ Time Frame: 14 days ]
  • Proportion of subjects achieving antibody responses to specific vaccine components with results ≥ thresholds defined for each vaccine component based on immunoglobulin-binding and/or opsonphagocytic activity assays [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2012)
  • Immunoglobulin titers measured as geometric mean titers for each antigen at each applicable blood sampling time point, as measured by antigen-specific antibody levels using an immunoglobulin binding assay. [ Time Frame: various, up to 12 months ]
  • Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates at each applicable blood sampling time point. [ Time Frame: various, up to 12 months ]
  • Immunoglobulin geometric mean fold rise for each of the vaccine components as measured by antigen-specific antibody levels using an immunoglobulin binding assay. [ Time Frame: 1 month ]
  • Geometric mean fold rise on opsonophagocytic activity assay titers against S. aureus isolates. [ Time Frame: 1 month ]
  • Proportion of subjects achieving antibody responses to specific antigens with results ≥ thresholds defined for each vaccine component at each applicable visit. [ Time Frame: Various, up to 12 months ]
  • Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in immunoglobulin titers from baseline to each applicable visit after vaccination for each antigen. [ Time Frame: Various, up to 12 months ]
  • Proportion of subjects with ≥2-fold, ≥4-fold, ≥8-fold, ≥16-fold, and ≥32-fold increase in opsonophagocytic activity titers against S. aureus isolates from baseline to each applicable visit after vaccination. [ Time Frame: Various, up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Single Vaccination of One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) and a Single Dose Level of a 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) in Healthy Adults Aged 65 to <86 Years
Official Title  ICMJE A Phase 1/2 Placebo-controlled, Randomized, Double-blind Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 3 Ascending Dose Levels Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) And A Single Dose Level Of A 3-antigen Staphylococcus Aureus Vaccine (sa3ag) In Healthy Adults Aged 65 To <86 Years
Brief Summary This is a Phase 1 and Phase 2 study of a single vaccination with one of three dose levels of a 4-antigen investigational vaccine against Staphylococcus aureus (SA4Ag) and a single dose level of a 3-antigen Staphylococcus aureus vaccine (SA3Ag). The main goal of the study is to determine how safe and well tolerated the vaccine is as well as to describe the immune response elicited by the vaccine in healthy adults aged 65 to <86 years. In addition, the study aims to assess the effect of the Staphylococcus aureus vaccine on the presence of the Staphylococcus aureus within the nose, throat and perineal skin of healthy adults aged 65 to <86 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Staphylococcal Infections
Intervention  ICMJE
  • Biological: SA4Ag vaccine low dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
  • Procedure: Blood draw
    Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
  • Procedure: Colonization swab sample
    Colonization swabs will be collected from all subjects at various timepoints.
  • Biological: SA4Ag vaccine mid dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
  • Biological: SA4Ag vaccine high dose
    Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
  • Biological: SA3Ag vaccine
    Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
  • Procedure: Blood sample
    Blood for immunogenicity will be collected from all subjects at various timepoints.
  • Biological: Placebo
    Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
  • Procedure: Colonization swab samples
    Colonization swabs will be collected from all subjects at various timepoints.
Study Arms  ICMJE
  • Experimental: 1
    SA4Ag vaccine low dose
    Interventions:
    • Biological: SA4Ag vaccine low dose
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
  • Experimental: 2
    SA4Ag vaccine mid dose
    Interventions:
    • Biological: SA4Ag vaccine mid dose
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
  • Experimental: 3
    SA4Ag vaccine high dose
    Interventions:
    • Biological: SA4Ag vaccine high dose
    • Procedure: Blood draw
    • Procedure: Colonization swab sample
  • Experimental: 4
    SA3Ag vaccine
    Interventions:
    • Biological: SA3Ag vaccine
    • Procedure: Blood sample
    • Procedure: Colonization swab sample
  • Placebo Comparator: 5
    Placebo
    Interventions:
    • Biological: Placebo
    • 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: April 11, 2014)
284
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)
273
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and healthy postmenopausal females, aged 65 to <86 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
  • Available for the entire duration of the study, and able to comply with scheduled visits, study plan, laboratory tests, and other study procedures including completion of the electronic diary (e diary) from Day 1 to Day 14 following vaccination.
  • Able to be contacted by telephone during study participation.
  • Male subjects who, in the opinion of the investigator, are biologically capable of fathering children, and who are sexually active with women of childbearing potential must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  • Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 3 months before receipt of study vaccine.
  • Serious chronic medical disorders or any disorder that in the investigator's opinion precludes the subject from participating in the study.
  • Donation of blood volume of 250 mL or greater or donation of plasma within 3 months prior to enrollment through conclusion of the study.
  • Bleeding condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low-dose daily aspirin within 30 days before enrollment through completion of Visit 6 (Day 29).
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine related components.
  • Immunocompromised persons or subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy. History of immune-modifying drugs.
  • Previous administration of S. aureus vaccination.
  • Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination.
  • Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 12 months before enrollment through conclusion of the study.
  • Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation. Participation in purely observational studies is acceptable.
  • Subjects who are investigational site staff members or subjects who are immediate family members (first-degree relatives) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
  • Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care. An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
  • A Mini-Mental State Examination (MMSE) score of ≤21.
  • For Phase 1 subjects only, any abnormality in screening hematology, coagulation, and/or blood chemistry laboratory values except as noted in protocol
  • Subjects with known active disease with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV), or Phase 1 subjects with a positive screening test for HIV, HBV and/or HCV.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Planned surgical procedure within 30 days following vaccination.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01643941
Other Study ID Numbers  ICMJE B3451011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP