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

Primary Purpose

Bacterial Infections, Staphylococcal Vaccines, Immunotherapy, Active

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

SA3Ag vaccine

Blood draw

Colonization swab samples

SA3Ag followed by Placebo

Blood draw

Colonization swab samples

Placebo

Blood draw

Colonization swab samples

SA3Ag with no booster in stage 2

Blood draw

Colonization swab samples

Placebo with no booster in stage 2

Blood draw

Colonization swab samples

About this trial

This is an interventional prevention trial for Bacterial Infections focused on measuring Staphylococcus aureus, Vaccine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Arm Description

SA3Ag in both stage 1 and stage 2

SA3Ag in stage 1 followed by placebo in stage 2.

Placebo in both stage 1 and stage 2

SA3Ag in stage 1 and no vaccine in stage 2.

Placebo in stage 1 and no vaccine in stage 2.

Outcomes

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).

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

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.

Ig titers for each antigen 28 days after the booster dose.

The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.

OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).

Full Information

NCT ID

NCT01018641

First Posted

November 20, 2009

Last Updated

April 23, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01018641

Brief Title

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

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Infections, Staphylococcal Vaccines, Immunotherapy, Active, Staphylococcal Skin Infections, Staphylococcal Infections

Keywords

Staphylococcus aureus, Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

449 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

SA3Ag in both stage 1 and stage 2

Arm Title

Arm Type

Experimental

Arm Description

SA3Ag in stage 1 followed by placebo in stage 2.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo in both stage 1 and stage 2

Arm Title

Arm Type

Experimental

Arm Description

SA3Ag in stage 1 and no vaccine in stage 2.

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo in stage 1 and no vaccine in stage 2.

Intervention Type

Biological

Intervention Name(s)

SA3Ag vaccine

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colonization swab samples

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

SA3Ag followed by Placebo

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colonization swab samples

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colonization swab samples

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

SA3Ag with no booster in stage 2

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colonization swab samples

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Placebo with no booster in stage 2

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Blood draw

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Colonization swab samples

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

1 month

Title

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

Time Frame

1 month

Secondary Outcome Measure Information:

Title

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

Title

Ig titers for each antigen 28 days after the booster dose.

Time Frame

7 months

Title

The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.

Time Frame

12 months

Title

OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Pfizer Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Pfizer Investigational Site

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Pfizer Investigational Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Pfizer Investigational Site

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

27519620

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.

Results Reference

derived

PubMed Identifier

25707693

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6123K1-1007&StudyName=An%20Evaluation%20Of%20Three%20Dose%20Levels%20Of%203-Antigen%20Staphylococcus%20Aureus%20Vaccine%20%28SA3Ag%29%20In%20Healthy%20Adults

Description

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

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