Clinical trial NCT05696080: Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) From Day 1 Through Day 5 Post-vaccination
timeFrame: Up to 5 days following each vaccination
measure: Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination
timeFrame: Up to 5 days following each vaccination
measure: Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study
timeFrame: Up to 194 days following Visit 2 (Day 1)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116
timeFrame: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.
Secondary outcomes:
measure: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116
timeFrame: 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.
measure: Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
timeFrame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
measure: Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23
timeFrame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
measure: Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116
timeFrame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
measure: Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116
timeFrame: Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Aventiv Research ( Site 0022)
state: Arizona
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0002)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A ( Site 0011)
state: Florida
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG ( Site 0012)
state: Mississippi
city: New Windsor
country: United States
facility: Mid Hudson Medical Research ( Site 0008)
state: New York
city: Kingsport
country: United States
facility: Holston Medical Group ( Site 0010)
state: Tennessee
city: Fort Worth
country: United States
facility: EmVenio Research ( Site 0018)
state: Texas
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital ( Site 0019)
state: Washington
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice ( Site 0402)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital ( Site 0400)
state: Queensland
city: Moncton
country: Canada
facility: G A Research Associates ( Site 0100)
state: New Brunswick
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0107)
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc. ( Site 0106)
state: Ontario
city: Mirabel
country: Canada
facility: Manna Research Mirabel ( Site 0105)
state: Quebec
city: Montreal
country: Canada
facility: Clinique de médecine Urbaine du Quartier Latin ( Site 0111)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres ( Site 0110)
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriavile Inc. ( Site 0102)
state: Quebec
city: Temuco
country: Chile
facility: Hospital Dr. Hernán Henríquez Aravena ( Site 1001)
state: Araucania
city: Talca
country: Chile
facility: Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)
state: Maule
city: Providencia
country: Chile
facility: Universidad San Sebastian - Providencia ( Site 1003)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: CESFAM Esmeralda ( Site 1009)
state: Region M. De Santiago
city: Kurume
country: Japan
facility: Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)
state: Fukuoka
city: Shimonoseki
country: Japan
facility: Shimonoseki Medical Center ( Site 0201)
state: Yamaguchi
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital ( Site 0303)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 0305)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0300)
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center ( Site 0302)
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital ( Site 0301)
city: Rotorua
country: New Zealand
facility: Pacific Clinical Research Network - Rotorua ( Site 0500)
state: Bay Of Plenty
city: Tauranga
country: New Zealand
facility: P3 Research - Tauranga ( Site 0507)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: CGM Research Trust ( Site 0505)
state: Canterbury
city: Christchurch
country: New Zealand
facility: Pacific Clinical Research Network - Forte ( Site 0501)
state: Canterbury
city: Lower Hutt
country: New Zealand
facility: P3 Research - Lower Hutt ( Site 0508)
state: Wellington
city: Wellington
country: New Zealand
facility: P3 Research - Wellington ( Site 0503)
city: Bydgoszcz
country: Poland
facility: IN VIVO ( Site 0601)
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun ( Site 0606)
state: Kujawsko-pomorskie
city: Skierniewice
country: Poland
facility: Clinmedica Research Sp. z. o. o. ( Site 0603)
state: Lodzkie
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk ( Site 0602)
state: Podkarpackie
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice ( Site 0604)
state: Slaskie
city: Katowice
country: Poland
facility: Clinical Medical Research ( Site 0605)
state: Slaskie
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Clinical Director
role: STUDY_DIRECTOR
References: