SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

NCT02492958 | Completed Phase 2 Results DMC

• 2 other identifiers: B34510036123K1-1006
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Staphylococcal Infections

Outcome Measures

Primary Outcomes (13)

• Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination

  Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined as mild (2.5 to 5.0 centimeters \[cm\]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to \[\>=\] 10.5 cm). Pain at injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.

  Day 1 up to Day 14

• Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination

  Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (\>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

  Day 1 up to Day 14

• Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination

  Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (\>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.

  Day 1 up to Day 14

• Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination

  Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).

  Day 1 up to Day 14

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.

  Day 1 up to Day 29

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

  After Day 29 up to Month 12

• Percentage of Participants With Hematology Abnormalities at Day 5

  Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.

  Day 5

• Percentage of Participants With Hematology Abnormalities at Day 15

  Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.

  Day 15

• Percentage of Participants With Coagulation Abnormalities at Day 5

  Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate \[ADP\], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.

  Day 5

• Percentage of Participants With Coagulation Abnormalities at Day 15

  Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.

  Day 15

• Percentage of Participants With Blood Chemistry Abnormalities at Day 5

  Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.

  Day 5

• Percentage of Participants With Blood Chemistry Abnormalities at Day 15

  Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.

  Day 15

• Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29

  Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.

  Day 29

Secondary Outcomes (7)

• Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3

  Baseline, Day 11, 15 and Month3

• Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)

  Baseline, Day 11, 15, 29 and Month 3

• Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)

  Baseline, Day 11, 15, 29 and Month 3

• Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)

  Baseline, Day 11, 15, 29 and Month 3

• Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3

  Baseline, Day 11, 15, 29 and Month 3

Study Arms (2)

SA4Ag

EXPERIMENTAL

Staphylococcus aureus 4-antigen vaccine

Biological: Staphylococcus aureus 4-antigen vaccine

Placebo

PLACEBO COMPARATOR

a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients

Biological: Placebo

Interventions

Staphylococcus aureus 4-antigen vaccine BIOLOGICAL

a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm

Also known as: SA4Ag

SA4Ag

Placebo BIOLOGICAL

a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm

Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)

Sumida-ku, Tokyo, 130-0004, Japan

Location

SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)

Fukuoka, 812-0025, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2018-07

Locations

JP (2)