Bacterial InfectionsPhase 1NCT01018641
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
A Phase 1 study testing SA3Ag vaccine, Blood draw and Colonization swab samples in people with Bacterial Infections and Staphylococcal Vaccines, run by Pfizer at 5 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections, Staphylococcal Vaccines, Immunotherapy, Active
- What is being tested?
- SA3Ag vaccine, Blood draw and Colonization swab samples
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 5 sitesAustralia
- Study dates
- Jan 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Herston, Queensland, 4029
Pfizer Investigational Site
North Adelaide, South Australia, 5006
Pfizer Investigational Site
Prahran, Victoria, 3004
Pfizer Investigational Site
Subiaco, Western Australia, 6008
About this study
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
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.
- Conditions
- Bacterial Infections, Staphylococcal Vaccines, Immunotherapy, Active, Staphylococcal Skin Infections, Staphylococcal Infections
- Being tested
- SA3Ag vaccine, Blood draw, Colonization swab samples, SA3Ag followed by Placebo, Placebo
- Keywords
- Staphylococcus aureus, Vaccine
- Medical subject headings
- Bacterial Infections, Motor Activity, Staphylococcal Skin Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA3Ag vaccineBiological
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 drawProcedure or surgery
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 samplesProcedure or surgery
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
SA3Ag followed by PlaceboBiological
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.
Blood drawProcedure or surgery
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 samplesProcedure or surgery
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
PlaceboBiological
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.
Blood drawProcedure or surgery
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 samplesProcedure or surgery
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
SA3Ag with no booster in stage 2Biological
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.
Blood drawProcedure or surgery
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 samplesProcedure or surgery
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Placebo with no booster in stage 2Procedure or surgery
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 drawProcedure or surgery
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 samplesProcedure or surgery
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SA3Ag in both stage 1 and stage 2 Receives: Biological: SA3Ag vaccine; Procedure: Blood draw; Procedure: Colonization swab samples |
| 2 | Experimental | SA3Ag in stage 1 followed by placebo in stage 2. Receives: Biological: SA3Ag followed by Placebo; Procedure: Blood draw; Procedure: Colonization swab samples |
| 3 | Placebo comparator | Placebo in both stage 1 and stage 2 Receives: Biological: Placebo; Procedure: Blood draw; Procedure: Colonization swab samples |
| 4 | Experimental | SA3Ag in stage 1 and no vaccine in stage 2. Receives: Biological: SA3Ag with no booster in stage 2; Procedure: Blood draw; Procedure: Colonization swab samples |
| 5 | Placebo comparator | Placebo in stage 1 and no vaccine in stage 2. Receives: Procedure: Placebo with no booster in stage 2; Procedure: Blood draw; Procedure: Colonization swab samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 month
The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
Measured: 1 month
Secondary outcomes (4)
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.
Measured: 1 month
Ig titers for each antigen 28 days after the booster dose.
Measured: 7 months
The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.
Measured: 12 months
OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018641
- Sponsor's protocol ID
- 6123K1-1007
- Other IDs
- B2251002
- Status last verified
- Apr 2014
- First submitted
- 20 Nov 2009
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27519620Nissen 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.
PubMed 25707693
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01018641
- Acronym / sponsor ID
- 6123K1-1007
- Conditions
- Bacterial Infections, Staphylococcal Vaccines, Immunotherapy, Active, Staphylococcal Skin Infections, Staphylococcal Infections
- Keywords
- Staphylococcus aureus, Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: SA3Ag vaccine, Procedure: Blood draw, Procedure: Colonization swab samplesSA3Ag in both stage 1 and stage 2 |
| 2 | Experimental | Biological: SA3Ag followed by Placebo, Procedure: Blood draw, Procedure: Colonization swab samplesSA3Ag in stage 1 followed by placebo in stage 2. |
| 3 | Placebo comparator | Biological: Placebo, Procedure: Blood draw, Procedure: Colonization swab samplesPlacebo in both stage 1 and stage 2 |
| 4 | Experimental | Biological: SA3Ag with no booster in stage 2, Procedure: Blood draw, Procedure: Colonization swab samplesSA3Ag in stage 1 and no vaccine in stage 2. |
| 5 | Placebo comparator | Procedure: Placebo with no booster in stage 2, Procedure: Blood draw, Procedure: Colonization swab samplesPlacebo in stage 1 and no vaccine in stage 2. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SA3Ag vaccineIn 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. | Biological | 1 |
| Blood drawBlood 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. | Procedure or surgery | 1 |
| Colonization swab samplesColonization swabs will be taken at timepoints throughout stage 1 and stage 2. | Procedure or surgery | 1 |
| SA3Ag followed by PlaceboIn 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. | Biological | 2 |
| Blood drawBlood 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. | Procedure or surgery | 2 |
| Colonization swab samplesColonization swabs will be taken at timepoints throughout stage 1 and stage 2. | Procedure or surgery | 2 |
| PlaceboIn 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. | Biological | 3 |
| Blood drawBlood 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. | Procedure or surgery | 3 |
| Colonization swab samplesColonization swabs will be taken at timepoints throughout stage 1 and stage 2. | Procedure or surgery | 3 |
| SA3Ag with no booster in stage 2In 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. | Biological | 4 |
| Blood drawBlood 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. | Procedure or surgery | 4 |
| Colonization swab samplesColonization swabs will be taken at timepoints throughout stage 1 and stage 2. | Procedure or surgery | 4 |
| Placebo with no booster in stage 2In 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. | Procedure or surgery | 5 |
| Blood drawBlood 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. | Procedure or surgery | 5 |
| Colonization swab samplesColonization swabs will be taken at timepoints throughout stage 1 and stage 2. | Procedure or surgery | 5 |
Primary outcome
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
The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
Time frame: 1 month
4 secondary outcomes
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
Ig titers for each antigen 28 days after the booster dose.
Time frame: 7 months
The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.
Time frame: 12 months
OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
- Derived from this study: PubMed 27519620Marshall 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.
- Derived from this study: PubMed 25707693Nissen 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SA3Ag vaccine, Blood draw and Colonization swab samples in people with Bacterial Infections and Staphylococcal Vaccines, run by Pfizer at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01018641, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.