Clinical trial NCT01018641: An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Staphylococcal Vaccines
Immunotherapy, Active
Staphylococcal Skin Infections
Staphylococcal Infections
Keywords: Staphylococcus aureus
Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 449
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.
* 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.

Primary outcomes:
measure: 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).
timeFrame: 1 month
measure: The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
timeFrame: 1 month
Secondary outcomes:
measure: 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.
timeFrame: 1 month
measure: Ig titers for each antigen 28 days after the booster dose.
timeFrame: 7 months
measure: The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.
timeFrame: 12 months
measure: OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).
timeFrame: 1 month
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: North Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Prahran
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Subiaco
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Marshall H, Nissen M, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber WC, Jansen KU, Anderson AS, Zito ET, Girgenti D. Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study. J Infect. 2016 Nov;73(5):437-454. doi: 10.1016/j.jinf.2016.08.004. Epub 2016 Aug 9.
citation: Nissen M, Marshall H, Richmond P, Shakib S, Jiang Q, Cooper D, Rill D, Baber J, Eiden J, Gruber W, Jansen KU, Emini EA, Anderson AS, Zito ET, Girgenti D. A randomized phase I study of the safety and immunogenicity of three ascending dose levels of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults. Vaccine. 2015 Apr 8;33(15):1846-54. doi: 10.1016/j.vaccine.2015.02.024. Epub 2015 Feb 21.