Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease

JRCT ID: jRCT2061220106

Registered date:03/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Pneumococcal infection prevention
• Date of first enrollment: 22/03/2023
• Target sample size: 30
• Countries of recruitment: United States,Japan,Poland,Japan,Chile,Japan,Mexico,Japan,Canada,Japan,Australia,Japan,New Zealand,Japan,South Korea,Japan
• Study type: Interventional
• Intervention(s): In V116 group, participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo on Week 8. In PCV15+PPSV23 group, participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Outcome(s)

• Primary Outcome: Serotype-specific OPA responses, Solicited AEs and vaccine related SAEs
• Secondary Outcome: Serotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

- Has documented result(s) of >=1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with >=1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements <=9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration).
- Is receiving stable medical management for the listed risk conditions for >=3 months with no anticipated major change in treatment expected for the duration of the study and with <=1 hospitalization directly related to the risk condition.
- Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator.

Exclude criteria

- Has a history of active hepatitis.
- Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1).
- Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1).
- Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class >=3 or history of Eisenmenger syndrome
- Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria
- Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years before first study vaccination (Day 1).
- Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid.
- Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease.
- Has a coagulation disorder contraindicating intramuscular (IM) vaccination.
- Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine.
- Has a known malignancy that is progressing or has required active treatment <3 years before randomization.
- Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study.
- Has expected survival for <1 year.
- Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol.
- Has received systemic corticosteroids (prednisone equivalent of >=20 mg/day) for >=14 consecutive days and has not completed intervention >=14 days before receipt of study vaccine at Visit 2 (Day 1).
- Is currently receiving systemic immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
- Has received any non-live vaccine <=14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine <=30 days after receipt of any study vaccine.
- Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) <=30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine <=30 days after receipt of any study vaccine
- Has received a blood transfusion or blood products, including immunoglobulin <=6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product <=30 days after receipt of any study vaccine.
- Is receiving chronic home oxygen therapy.

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05696080