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
- Conditions
- Staphylococcal Infections
- Interventions
- Biological: SA4Ag vaccine low doseBiological: SA4Ag vaccine mid doseBiological: SA4Ag vaccine high doseBiological: PlaceboProcedure: Blood drawProcedure: Blood sampleProcedure: Colonization swab sample
- Registration Number
- NCT01364571
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 456
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 SA4Ag vaccine low dose SA4Ag vaccine low dose 3 Colonization swab sample SA4Ag vaccine high dose 1 Colonization swab sample SA4Ag vaccine low dose 2 SA4Ag vaccine mid dose SA4Ag vaccine mid dose 2 Colonization swab sample SA4Ag vaccine mid dose 3 Blood draw SA4Ag vaccine high dose 3 SA4Ag vaccine high dose SA4Ag vaccine high dose 1 Blood draw SA4Ag vaccine low dose 4 Placebo Placebo 4 Blood draw Placebo 2 Blood sample SA4Ag vaccine mid dose 4 Colonization swab sample Placebo
- Primary Outcome Measures
Name Time Method 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. 14 days 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) 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 14 days 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. 1 month Number and proportion of subjects reporting unsolicited AEs and serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA) 1 month (AEs), 6 months (SAEs)
- Secondary Outcome Measures
Name Time Method Immunoglobulin geometric mean fold rise (GMFR) for each antigen 1 month Immunoglobulin concentrations for each antigen at each applicable blood sampling time point, various, up to 12 months Geometric mean fold rise on opsonophagocytic activity assay titers 1 month Opsonophagocytic activity (OPA) titers at each applicable blood sampling time point, 1 month 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 various, up to 12 months
Trial Locations
- Locations (15)
Miami Research Associates
🇺🇸South Miami, Florida, United States
Buffalo Clinical Research Center, LLC
🇺🇸Buffalo, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Roberta Braun, M.D.
🇺🇸Austin, Texas, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Prism Research
🇺🇸Saint Paul, Minnesota, United States
Benchmark Research
🇺🇸Austin, Texas, United States
SNBL Clinical Pharmacology Center, Inc.
🇺🇸Baltimore, Maryland, United States
Broward Research Group
🇺🇸Hollywood, Florida, United States
New Orleans Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States