Phase 2
Completed N=136
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Staphylococcal Infections
Source: ClinicalTrials.gov NCT02492958 ↗
Enrolled (actual)
136
Serious AEs
4.4%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination — 2.9; 20.6; 5.9; 29.4 Percentage of participants
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination |
2.9; 20.6; 5.9; 29.4 | — |
| PRIMARY Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination |
2.9; 2.9; 2.9; 5.9; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination |
29.4; 29.4; 17.6; 35.3 | — |
| PRIMARY Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination |
0.0; 5.9; 2.9; 5.9; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit |
5.9; 2.9; 5.9; 5.9 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12 |
2.9; 0.0; 5.9; 11.8; 2.9; 0.0 | — |
| PRIMARY Percentage of Participants With Hematology Abnormalities at Day 5 |
0.0; 16.7; 0.0; 0.0; 0.0; 16.7 | — |
| PRIMARY Percentage of Participants With Hematology Abnormalities at Day 15 |
16.7; 50.0; 0.0; 16.7; 0.0; 33.3 | — |
| PRIMARY Percentage of Participants With Coagulation Abnormalities at Day 5 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Coagulation Abnormalities at Day 15 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Blood Chemistry Abnormalities at Day 5 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Blood Chemistry Abnormalities at Day 15 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29 |
25.8; 100.0; 15.6; 100.0; 17.6; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3 |
20.6; 23.5; 11.8; 14.7; 15.2; 33.3 | — |
| SECONDARY Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs) |
200.7; 218.1; 216.6; 174.0; 349.4; 376.8 | — |
| SECONDARY Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) |
355.1; 301.7; 349.0; 332.9; 512.9; 702.5 | — |
| SECONDARY Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs) |
67.2; 60.5; 63.3; 60.5; 68.4; 755.5 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3 |
1.0; 18.8; 0.9; 19.5; 1.0; 13.3 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3 |
1.0; 125.0; 0.9; 93.3; 1.1; 38.7 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3 |
1.0; 12.5; 1.0; 10.3; 1.0; 14.4 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese male and female adults aged 20 to <86 years,
- Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
- Must be available for the 12 month duration of the study,
- Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).
Exclusion Criteria
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
- Unstable or serious chronic medical condition that would increase the subject's risk of participation,
- Immune system suppression or treatment with medications that suppress the immune system,
- Receipt of blood products or immunoglobulins within the past 12 months,
- Any infection proven or suspected to be caused by S.aureus within the past 6 months,
- A staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study,
- Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,
- A pregnant or a breast feeding woman.
Data sourced from ClinicalTrials.gov (NCT02492958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.