An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults

Bacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018641
• Other study ID #: 6123K1-1007
• Secondary ID: B2251002
• Status: Completed
• Phase: Phase 1
• First received: November 20, 2009
• Last updated: April 23, 2014
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Immunotherapy, Active
• Infection
• Skin Diseases, Infectious
• Staphylococcal Infections
• Staphylococcal Skin Infections
• Staphylococcal Vaccines

Intervention

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.
• Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and 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.
• Colonization swab samples
Colonization swabs will be taken at timepoints throughout 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.
• Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and 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.
• Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
• 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.
• 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.
• Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Herston	Queensland
Australia	Pfizer Investigational Site	North Adelaide	South Australia
Australia	Pfizer Investigational Site	Prahran	Victoria
Australia	Pfizer Investigational Site	Subiaco	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		1 month	No
Primary	The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.		1 month	No
Secondary	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	No
Secondary	Ig titers for each antigen 28 days after the booster dose.		7 months	No
Secondary	The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.		12 months	Yes
Secondary	OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).		1 month	No

External Links

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