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Staphylococcal InfectionsPhase 1NCT02364596

Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years

A Phase 1 study testing SA4Ag vaccine and Blood sample in people with Staphylococcal Infections, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of a single vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy adults aged 18 to <65 years. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Staphylococcal Infections
What is being tested?
SA4Ag vaccine and Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesUnited States
Study dates
Jan 2015to Feb 2015
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 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including daily completion of the e-diary for 10 days after study vaccination. 3. Healthy male and female subjects, aged 18 to <65 years at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included. 4. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. 5. Subject must be able to be contacted by telephone during study participation.

Exclusion Criteria: 1. Unstable chronic medical condition or disease requiring significant change in therapya or hospitalization for worsening disease within 3 months before receipt of investigational product. 2. Serious chronic medical disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study. 3. Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment or the use of systemic corticosteroids (equivalent of ≥10 mg/day of prednisone) for >14 days within 30 days prior to study enrollment. 4. History of leukemia, lymphoma, or underlying bone marrow disorder (eg, myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant. 5. Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment. 6. Any infection proven or suspected to be caused by S. aureus within 6 months preceding study vaccination. 7. Previous administration of S. aureus vaccine or S. aureus/Candida vaccine. 8. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. 9. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 10. Donation of blood volume of 250 mL or greater (excluding protocol-required blood collection) or donation of plasma within 3 months prior to enrollment through conclusion of the study. 11. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months before enrollment or anticipated through conclusion of the subject's participation. 12. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study. 13. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Participation in observational studies is permitted. 14. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential and at risk for pregnancy who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study. 15. Residence in a nursing home or long-term care facility or requirement for semiskilled nursing care. An ambulatory subject who is a resident of a retirement home or village is eligible for the trial. 16. Subjects with known active disease with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). 17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Broward Research Group

    Hollywood, Florida, 33024

  • Miami Research Associates

    South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1, Single-arm, Open-label Study To Confirm The Safety, Tolerability, And Immunogenicity Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years

The purpose of this study is to evaluate the safety and immunogenicity of a single vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy adults aged 18 to <65 years.

Being tested
SA4Ag vaccine, Blood sample
Keywords
Staphylococcus aureus vaccine, Staphylococcal infection
Medical subject headings
Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SA4Ag vaccineBiological

    Subjects receive 1 intramuscular injection (0.5 mL) of the SA4Ag vaccine.

  • Blood sampleProcedure or surgery

    Blood for immunogenicity will be collected from all subjects at various timepoints.

Study groups in NCT02364596
Study groupRoleWhat they receive
1ExperimentalSA4Ag vaccine
Receives: Biological: SA4Ag vaccine; Procedure: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects reporting local reactions (redness, swelling, and pain at the injection site) as self-reported on electronic diaries (e-diaries) for 10 days after vaccination.

    Measured: 10 days

  2. Number of subjects reporting systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle pain, and joint pain) as self-reported on e-diaries for 10 days after vaccination.

    Measured: 10 days

  3. Number of subjects reporting adverse events (AEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: 1 month

  4. Number of subjects reporting serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: 1 month

  5. Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates

    Measured: 1 month

Secondary outcomes (1)
  1. Competitive Luminex immunoassay titers summarized as geometric mean titers for S. aureus antigens

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364596
Sponsor's protocol ID
B3451015
Status last verified
Apr 2015
First submitted
8 Jan 2015
Last updated
3 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Begier E, Seiden DJ, Patton M, Zito E, Severs J, Cooper D, Eiden J, Gruber WC, Jansen KU, Anderson AS, Gurtman A. SA4Ag, a 4-antigen Staphylococcus aureus vaccine, rapidly induces high levels of bacteria-killing antibodies. Vaccine. 2017 Feb 22;35(8):1132-1139. doi: 10.1016/j.vaccine.2017.01.024. Epub 2017 Jan 28.

    PubMed 28143674

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SA4Ag vaccine and Blood sample in people with Staphylococcal Infections, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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?

Number of subjects reporting local reactions (redness, swelling, and pain at the injection site) as self-reported on electronic diaries (e-diaries) for 10 days after vaccination. (time frame: 10 days). The study lists 5 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 NCT02364596, which also lists 1 linked publication.

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 3 Apr 2015.

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