Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumococcal Infection

In brief

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.

Key facts

Study ID

NCT05696080

Run by

Merck Sharp & Dohme LLC

People needed

518

Starts

2023-02-13

Expected to finish

2024-02-16

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aventiv Research ( Site 0022) — Mesa, Arizona, United States
• Indago Research & Health Center, Inc ( Site 0002) — Hialeah, Florida, United States
• Triple O Research Institute, P.A ( Site 0011) — West Palm Beach, Florida, United States
• SKY Integrative Medical Center/SKYCRNG ( Site 0012) — Ridgeland, Mississippi, United States
• Mid Hudson Medical Research ( Site 0008) — New Windsor, New York, United States
• Holston Medical Group ( Site 0010) — Kingsport, Tennessee, United States
• EmVenio Research ( Site 0018) — Fort Worth, Texas, United States
• Wenatchee Valley Hospital ( Site 0019) — Wenatchee, Washington, United States
• Holdsworth House Medical Practice ( Site 0402) — Darlinghurst, New South Wales, Australia
• Royal Brisbane and Women's Hospital ( Site 0400) — Brisbane, Queensland, Australia
• G A Research Associates ( Site 0100) — Moncton, New Brunswick, Canada
• Hamilton Medical Research Group ( Site 0107) — Hamilton, Ontario, Canada
• Milestone Research Inc. ( Site 0106) — London, Ontario, Canada
• Manna Research Mirabel ( Site 0105) — Mirabel, Quebec, Canada
• Clinique de médecine Urbaine du Quartier Latin ( Site 0111) — Montreal, Quebec, Canada
• Diex Recherche Trois-Rivieres ( Site 0110) — Trois-Rivières, Quebec, Canada
• Diex Recherche Victoriavile Inc. ( Site 0102) — Victoriaville, Quebec, Canada
• Hospital Dr. Hernán Henríquez Aravena ( Site 1001) — Temuco, Araucania, Chile
• Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010) — Talca, Maule Region, Chile
• Universidad San Sebastian - Providencia ( Site 1003) — Providencia, Region M. de Santiago, Chile
• Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008) — Santiago, Region M. de Santiago, Chile
• Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004) — Santiago, Region M. de Santiago, Chile
• Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006) — Santiago, Region M. de Santiago, Chile
• CESFAM Esmeralda ( Site 1009) — Santiago, Region M. de Santiago, Chile
• Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200) — Kurume, Fukuoka, Japan

Full record on ClinicalTrials.gov

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