safety and immunogenicity of v116 in adults with increased risk for pneumococcal disease (v116-008)

Conditions: Pneumococcal Infection

Summary: the primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (v116), and to evaluate the serotype-specific opsonophagocytic activity (opa) post-vaccination with v116 and pcv15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + ppsv23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.


Eligibility criteria:
inclusion 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. exclusion 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.