Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
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
1 other identifier
interventional
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2015
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedApril 3, 2015
April 1, 2015
1 month
January 8, 2015
April 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
10 days
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.
10 days
Number of subjects reporting adverse events (AEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
1 month
Number of subjects reporting serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA).
1 month
Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates
1 month
Secondary Outcomes (1)
Competitive Luminex immunoassay titers summarized as geometric mean titers for S. aureus antigens
1 month
Study Arms (1)
1
EXPERIMENTALSA4Ag vaccine
Interventions
Blood for immunogenicity will be collected from all subjects at various timepoints.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Broward Research Group
Hollywood, Florida, 33024, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Related Publications (1)
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.
PMID: 28143674DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2015
First Posted
February 18, 2015
Study Start
January 1, 2015
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
April 3, 2015
Record last verified: 2015-04