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
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Staphylococcal Vaccines
Immunotherapy, Active
Staphylococcal Skin Infections
Staphylococcal Infections
Biological: SA3Ag vaccine
Procedure: Blood draw
Procedure: Colonization swab samples
Biological: SA3Ag followed by Placebo
Biological: Placebo
Biological: SA3Ag with no booster in stage 2
Procedure: Placebo with no booster in stage 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 449
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SA3Ag in both stage 1 and stage 2
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.
Experimental: 2
SA3Ag in stage 1 followed by placebo in 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.

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.
Placebo Comparator: 3
Placebo in both stage 1 and stage 2
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.
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.
Experimental: 4
SA3Ag in stage 1 and no vaccine in stage 2.
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: 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.
Placebo Comparator: 5
Placebo in stage 1 and no vaccine in stage 2.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01018641

Locations
Australia, Queensland
Pfizer Investigational Site
Herston, Queensland, Australia, 4029
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Pfizer Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Pfizer Investigational Site
Prahran, Victoria, Australia, 3004
Australia, Western Australia
Pfizer Investigational Site
Subiaco, Western Australia, Australia, 6008
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: NCT01018641     History of Changes
Other Study ID Numbers: 6123K1-1007, B2251002
Study First Received: November 20, 2009
Last Updated: April 23, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Pfizer:
Staphylococcus aureus
Vaccine

Additional relevant MeSH terms:
Bacterial Infections
Skin Diseases, Infectious
Staphylococcal Infections
Staphylococcal Skin Infections
Infection
Skin Diseases
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial

ClinicalTrials.gov processed this record on August 21, 2014