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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Immunotherapy, Active; Staphylococcal Infections; Staphylococcal Skin Infections; Staphylococcal Vaccines; Bacterial Infections

Treatments: Procedure: Blood draw; Biological: SA3Ag vaccine; Biological: SA3Ag followed by Placebo; Biological: SA3Ag with no booster in stage 2; Procedure: Placebo with no booster in stage 2; Procedure: Colonization swab samples; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018641

B2251002

6123K1-1007

Details and patient eligibility

About

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.

Enrollment: 449 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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449 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

SA3Ag in both stage 1 and stage 2

Treatment:

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Biological: SA3Ag vaccine

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Blood draw

2

Experimental group

Description:

SA3Ag in stage 1 followed by placebo in stage 2.

Treatment:

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Biological: SA3Ag followed by Placebo

Procedure: Colonization swab samples

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Blood draw

3

Placebo Comparator group

Description:

Placebo in both stage 1 and stage 2

Treatment:

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Biological: Placebo

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Blood draw

4

Experimental group

Description:

SA3Ag in stage 1 and no vaccine in stage 2.

Treatment:

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Blood draw

Biological: SA3Ag with no booster in stage 2

5

Placebo Comparator group

Description:

Placebo in stage 1 and no vaccine in stage 2.

Treatment:

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Placebo with no booster in stage 2

Procedure: Blood draw

Procedure: Colonization swab samples

Procedure: Colonization swab samples

Procedure: Blood draw

Procedure: Blood draw