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Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01364571
First received: May 31, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag). 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 18 to <65 years. In addition, the study aims to assess the effect of the SA4Ag vaccine on the presence of the Staphylococcus aureus on the skin and within the nose, throat and perineum of healthy adults aged 18 to <65 years.


Condition Intervention Phase
Staphylococcal Infections
Biological: SA4Ag vaccine low dose
Procedure: Blood draw
Procedure: Colonization swab sample
Biological: SA4Ag vaccine mid dose
Procedure: Blood sample
Biological: SA4Ag vaccine high dose
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase I/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) in Healthy Adults Aged 18 to <65 Years

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number and proportion of subjects reporting 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Number and proportion of Phase 1 subjects with abnormal hematology, coagulation and blood chemistry lab assessments; number and proportion of Phase 1 subjects with grading shifts in hematology, coagulation and blood chemistry laboratory assessments. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine based on immunoglobulin-binding and/or opsonophagocytic activity assays. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunoglobulin concentrations for each antigen at each applicable blood sampling time point, [ Time Frame: various, up to 12 months ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point, [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Immunoglobulin geometric mean fold rise (GMFR) for each antigen [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Geometric mean fold rise on opsonophagocytic activity assay titers [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving antibody responses to specific antigens with results greater than or equal to thresholds specific to each of the 4 antigens in the vaccine at at each applicable visit [ Time Frame: various, up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 456
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SA4Ag vaccine low dose
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 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 time points throughout the study.
Experimental: 2
SA4Ag vaccine mid dose
Biological: SA4Ag vaccine mid dose
Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
Procedure: Blood sample
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 time points throughout the study.
Experimental: 3
SA4Ag vaccine high dose
Biological: SA4Ag vaccine high dose
Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
Procedure: Blood draw
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 time points throughout the study.
Placebo Comparator: 4
Placebo
Biological: Placebo
Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
Procedure: Blood draw
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 time points throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18 to <65 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.
  • Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (e-diary) from Day 1 to Day 14 following vaccination(s).
  • Ability to be contacted by telephone during study participation.
  • All male and female subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study.

Exclusion Criteria:

  • Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization within 3 months before receipt of study vaccine.
  • Serious chronic medical disorders and any other disorder that in the investigator's opinion precludes the subject from participating in the study
  • Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection), or donation of plasma within 3 months prior to enrollment.
  • 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 1 month post-vaccination.
  • Any contraindication to vaccination or vaccine components.
  • Immunocompromised persons and subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents or long term systemic corticosteroids.
  • 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.
  • Subjects who are investigational site staff members or subjects who are immediate family members (1st 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.
  • For Phase 1 subjects only, any abnormality in screening hematology, coagulation and/or blood chemistry laboratory values.
  • Women who are pregnant (as determined by urine pregnancy test) or breastfeeding.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364571

Locations
United States, Florida
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33026
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Kentucky
Pfizer Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
United States, New York
Pfizer Investigational Site
Buffalo, New York, United States, 14202
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27518
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45229
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45206
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Houston, Texas, United States, 77081
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01364571     History of Changes
Other Study ID Numbers: B3451001, 6123K1-1005
Study First Received: May 31, 2011
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Staphylococcus aureus
vaccine
staphylococcal infection

Additional relevant MeSH terms:
Infection
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on November 25, 2014