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

NCT ID: NCT05696080

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 518 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2024-02-16

Brief 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.

Conditions

Pneumococcal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V116 + Placebo

Participants administered a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo on Week 8.

Group Type: EXPERIMENTAL

V116

Intervention Type: BIOLOGICAL

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Placebo

Intervention Type: BIOLOGICAL

Saline in each 0.5 mL sterile solution

PCV15 + PPSV23

Participants administered a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.

Group Type: ACTIVE_COMPARATOR

PCV15

Intervention Type: BIOLOGICAL

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension

PPSV23

Intervention Type: BIOLOGICAL

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Interventions

V116

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Intervention Type: BIOLOGICAL

Placebo

Saline in each 0.5 mL sterile solution

Intervention Type: BIOLOGICAL

PCV15

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension

Intervention Type: BIOLOGICAL

PPSV23

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal 21-valent Conjugate Vaccine; VAXNEUVANCE™; PNEUMOVAX™23

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

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

Hospital Dr. Hernán Henríquez Aravena ( Site 1001)

Temuco, Región de la Araucanía, Chile

Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)

Kurume, Fukuoka, Japan

Shimonoseki Medical Center ( Site 0201)

Shimonoseki, Yamaguchi, Japan

Pacific Clinical Research Network - Rotorua ( Site 0500)

Rotorua, Bay of Plenty, New Zealand

P3 Research - Tauranga ( Site 0507)

Tauranga, Bay of Plenty, New Zealand

CGM Research Trust ( Site 0505)

Christchurch, Canterbury, New Zealand

Pacific Clinical Research Network - Forte ( Site 0501)

Christchurch, Canterbury, New Zealand

P3 Research - Lower Hutt ( Site 0508)

Lower Hutt, Wellington Region, New Zealand

P3 Research - Wellington ( Site 0503)

Wellington, , New Zealand

IN VIVO ( Site 0601)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Torun ( Site 0606)

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Medyk ( Site 0602)

Rzeszów, Podkarpackie Voivodeship, Poland

Centrum Medyczne Pratia Katowice ( Site 0604)

Katowice, Silesian Voivodeship, Poland

Clinical Medical Research ( Site 0605)

Katowice, Silesian Voivodeship, Poland

Clinmedica Research Sp. z. o. o. ( Site 0603)

Skierniewice, Łódź Voivodeship, Poland

Hallym University Sacred Heart Hospital ( Site 0303)

Anyang-si, Kyonggi-do, South Korea

Korea University Anam Hospital ( Site 0305)

Seoul, , South Korea

Seoul National University Hospital ( Site 0300)

Seoul, , South Korea

Konkuk University Medical Center ( Site 0302)

Seoul, , South Korea

Hallym University Kangdong Sacred Heart Hospital ( Site 0301)

Seoul, , South Korea

Countries

United States; Australia; Canada; Chile; Japan; New Zealand; Poland; South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26329&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

V116-008

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2061220106

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-502791-22

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1282- 1460

Identifier Type: OTHER

Identifier Source: secondary_id

V116-008

Identifier Type: -

Identifier Source: org_study_id