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NCT Number: NCT01018641

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Behavior Gram-Positive Bacterial Infections Immunotherapy, Active Infections Motor Activity Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Staphylococcal Vaccines

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Herston, Queensland, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SA3Ag vaccine

Biological

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.

Blood draw

Procedure

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

Procedure

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

SA3Ag followed by Placebo

Biological

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.

Placebo

Biological

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.

SA3Ag with no booster in stage 2

Biological

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.

Placebo with no booster in stage 2

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  1. 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

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

    Time frame: 7 months

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

    Time frame: 12 months

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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2009
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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