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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01018641




Registration number
NCT01018641
Ethics application status
Date submitted
20/11/2009
Date registered
23/11/2009
Date last updated
24/04/2014

Titles & IDs
Public title
An Evaluation Of Three Dose Levels Of 3-Antigen Staphylococcus Aureus Vaccine (SA3Ag) In Healthy Adults
Scientific 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
Secondary ID [1] 0 0
B2251002
Secondary ID [2] 0 0
6123K1-1007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections 0 0
Staphylococcal Vaccines 0 0
Immunotherapy, Active 0 0
Staphylococcal Skin Infections 0 0
Staphylococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SA3Ag vaccine
Treatment: Surgery - Blood draw
Treatment: Surgery - Colonization swab samples
Treatment: Other - SA3Ag followed by Placebo
Treatment: Surgery - Blood draw
Treatment: Surgery - Colonization swab samples
Treatment: Other - Placebo
Treatment: Surgery - Blood draw
Treatment: Surgery - Colonization swab samples
Treatment: Other - SA3Ag with no booster in stage 2
Treatment: Surgery - Blood draw
Treatment: Surgery - Colonization swab samples
Treatment: Surgery - Placebo with no booster in stage 2
Treatment: Surgery - Blood draw
Treatment: Surgery - Colonization swab samples

Experimental: 1 - SA3Ag in both stage 1 and stage 2

Experimental: 2 - SA3Ag in stage 1 followed by placebo in stage 2.

Placebo comparator: 3 - Placebo in both stage 1 and stage 2

Experimental: 4 - SA3Ag in stage 1 and no vaccine in stage 2.

Placebo comparator: 5 - Placebo in stage 1 and no vaccine in stage 2.


Treatment: Other: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Treatment: Other: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Treatment: Other: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Treatment: Other: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.

Treatment: Surgery: 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.

Treatment: Surgery: 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.

Treatment: Surgery: Colonization swab samples
Colonization swabs will be taken at timepoints throughout stage 1 and stage 2.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
The primary comparison of interest is a 2-fold increase in Ig titers relative to baseline for each antigen.
Timepoint [2] 0 0
1 month
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Ig titers for each antigen 28 days after the booster dose.
Timepoint [2] 0 0
7 months
Secondary outcome [3] 0 0
The safety endpoints are solicited and unsolicited AEs, SAEs, and hematologic and urine parameters.
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
OPA titers for each antigen 28 days after vaccination in both age strata at selected dose level cohort(s).
Timepoint [4] 0 0
1 month

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
449
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [3] 0 0
Pfizer Investigational Site - North Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Prahran
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Prahran
Recruitment postcode(s) [5] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01018641
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01018641