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

Pfizer1 site in 1 country449 target enrollmentJanuary 2010

ConditionsBacterial Infections Staphylococcal Vaccines Immunotherapy, Active Staphylococcal Skin Infections Staphylococcal Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Bacterial Infections
Sponsor: Pfizer
Enrollment: 449
Locations: 1
Primary Endpoint: 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).
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

July 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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

The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.

Time Frame: 1 month

Secondary Outcomes

The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.(12 months)
OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).(1 month)
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.(1 month)
Ig titers for each antigen 28 days after the booster dose.(7 months)