Clinical trial NCT05420961: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Official title: A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 717
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Detailed description: Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has received pneumococcal vaccine \>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD).
* Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
* Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
* Has a coagulation disorder contraindicating intramuscular vaccination.
* Has a known malignancy that is progressing or has required active treatment.
* Has received PPSV23 followed by either PCV15 or PCV20.
* Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
* Is currently receiving 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 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 ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine.
* Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
timeFrame: Up to 5 days post-vaccination
measure: Percentage of Participants With Solicited Systemic AEs
timeFrame: Up to 5 days post-vaccination
measure: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
timeFrame: Up to ~180 days
measure: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
timeFrame: 30 Days post-vaccination
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
timeFrame: 30 Days post-vaccination
measure: Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
timeFrame: Day 1 (Baseline) and 30 days post-vaccination
measure: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
timeFrame: Day 1 (Baseline) and 30 days post-vaccination
measure: Geometric Mean Fold Rise of Serotype-specific IgG
timeFrame: Day 1 (Baseline) and 30 days post-vaccination
measure: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
timeFrame: Day 1 (Baseline) and 30 days post-vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates ( Site 0024)
state: Alabama
city: Glendale
country: United States
facility: Lenzmeier Family Medicine/CCT Research ( Site 0008)
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
state: Arizona
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center ( Site 0026)
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc. ( Site 0019)
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0020)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0005)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute ( Site 0018)
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research ( Site 0025)
state: Idaho
city: Elkridge
country: United States
facility: Centennial Medical Group ( Site 0002)
state: Maryland
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
state: Michigan
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC ( Site 0009)
state: Nebraska
city: Maumee
country: United States
facility: Advanced Medical Research ( Site 0001)
state: Ohio
city: Galveston
country: United States
facility: University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0003)
state: Virginia
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0114)
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc. ( Site 0104)
state: Ontario
city: Mirabel
country: Canada
facility: Manna Research Mirabel ( Site 0109)
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc. ( Site 0101)
state: Quebec
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 0202)
state: Aquitaine
city: Brest
country: France
facility: CHRU de Brest ( Site 0200)
state: Finistere
city: Pierre-Bénite
country: France
facility: centre hospitalier lyon sud ( Site 0204)
state: Rhone
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0303)
city: Holon
country: Israel
facility: Maccabi Health Services - Holon ( Site 0305)
city: Jerusalem
country: Israel
facility: Maccabi Healthcare Services ( Site 0306)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0301)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele ( Site 0403)
state: Lombardia
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone ( Site 0402)
state: Sicilia
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
city: Fukuoka
country: Japan
facility: PS Clinic ( Site 0700)
city: Kumamoto
country: Japan
facility: Nishikumamoto Hospital ( Site 0701)
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 0755)
state: Incheon
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital ( Site 0751)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 0750)
city: Barcelona
country: Spain
facility: HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
state: Cataluna
city: Centelles
country: Spain
facility: EBA CENTELLES ( Site 0500)
state: Cataluna
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge ( Site 0505)
state: Cataluna
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
state: Madrid
city: Benalmadena
country: Spain
facility: Hospital Internacional Xanit ( Site 0520)
state: Malaga
city: Madrid
country: Spain
facility: Hospital La Princesa ( Site 0515)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0801)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0800)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.