Clinical trial NCT05425732: Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 2663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.


Eligibility criteria: Inclusion Criteria:

* For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.

Exclusion Criteria:

* 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 of Visit 1 (Day 1)
* Has a known hypersensitivity to any component of V116 or PCV20, 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 IM vaccination
* Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\] or axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for any acute illness occurring \<72 hours before receipt of study vaccine
* Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
* Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
* 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
* 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
* Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
* 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
* 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 postvaccination 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 AE (SAE)
timeFrame: Up to 194 days post-vaccination
measure: Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Day 30 post-vaccination
measure: Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116
timeFrame: Baseline and Day 30 post-vaccination
measure: Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116
timeFrame: Day 30 post-vaccination
Secondary outcomes:
measure: Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes
timeFrame: Baseline and Day 30 post-vaccination
measure: Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2
timeFrame: Day 30 post-vaccination
measure: Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Day 30 post-vaccination
measure: Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Baseline and Day 30 post-vaccination
measure: Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Baseline and Day 30 post-vaccination
measure: Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Baseline and Day 30 post-vaccination
measure: Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20
timeFrame: Baseline and Day 30 post-vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates ( Site 0067)
state: Alabama
city: Glendale
country: United States
facility: Lenzmeier Family Medicine/CCT Research ( Site 0006)
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research/ CCT Research ( Site 0040)
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center/ CCT Research ( Site 0021)
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research ( Site 0019)
state: Arkansas
city: Fountain Valley
country: United States
facility: Southland Clinical Research Center-Research ( Site 0054)
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research ( Site 0024)
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials ( Site 0048)
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc ( Site 0018)
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates ( Site 0079)
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research ( Site 0083)
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials ( Site 0013)
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver ( Site 0012)
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc ( Site 0027)
state: Colorado
city: Atlantis
country: United States
facility: JEM Research Institute ( Site 0072)
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0015)
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research ( Site 0049)
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC ( Site 0070)
state: Florida
city: Lake City
country: United States
facility: East Coast Institute for Research ( Site 0071)
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute ( Site 0025)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute ( Site 0014)
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando ( Site 0031)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0016)
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ( Site 0007)
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center ( Site 0060)
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime ( Site 0010)
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research ( Site 0008)
state: Idaho
city: Versailles
country: United States
facility: Versailles Family Medicine / CCT Research ( Site 0063)
state: Kentucky
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)
state: Michigan
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0026)
state: Missouri
city: Elkhorn
country: United States
facility: Skyline Medical Center/CCT Research ( Site 0028)
state: Nebraska
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research ( Site 0058)
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC ( Site 0045)
state: Nebraska
city: Las Vegas
country: United States
facility: Healor Primary Care / CCT Research ( Site 0056)
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC ( Site 0077)
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)
state: Nevada
city: Horseheads
country: United States
facility: Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)
state: New York
city: Columbus
country: United States
facility: Aventiv Research Inc ( Site 0044)
state: Ohio
city: Maumee
country: United States
facility: Advanced Medical Research ( Site 0002)
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman ( Site 0001)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute ( Site 0005)
state: Oklahoma
city: Tulsa
country: United States
facility: Lynn Institute of Tulsa ( Site 0084)
state: Oklahoma
city: Portland
country: United States
facility: Summit Headlands ( Site 0047)
state: Oregon
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville ( Site 0043)
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates ( Site 0089)
state: South Carolina
city: Austin
country: United States
facility: Tekton Research, Inc. ( Site 0053)
state: Texas
city: Dallas
country: United States
facility: WR-Global Medical Research, LLC ( Site 0065)
state: Texas
city: Houston
country: United States
facility: Elixir Research Group - W Houston ( Site 0068)
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research ( Site 0082)
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 0051)
state: Texas
city: Plano
country: United States
facility: Research Your Health ( Site 0042)
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio ( Site 0009)
state: Texas
city: San Antonio
country: United States
facility: VIP Trials ( Site 0086)
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)
state: Texas
city: Holladay
country: United States
facility: Olympus Family Medicine/CCT Research ( Site 0074)
state: Utah
city: Ogden
country: United States
facility: South Ogden Family Medicine/ CCT Research ( Site 0022)
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research ( Site 0034)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0004)
state: Virginia
city: Spokane
country: United States
facility: MultiCare Rockwood Cheney Clinic ( Site 0037)
state: Washington
city: Bruce
country: Australia
facility: Paratus Clinical Research Canberra ( Site 3000)
state: Australian Capital Territory
city: Botany
country: Australia
facility: Emeritus Research ( Site 3004)
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast ( Site 3001)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 3005)
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research ( Site 3003)
state: Victoria
city: Diepenbeek
country: Belgium
facility: Anima Diepenbeek ( Site 1003)
state: Limburg
city: Erpent
country: Belgium
facility: Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)
state: Namur
city: Temuco
country: Chile
facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)
state: Araucania
city: Providencia
country: Chile
facility: Universidad San Sebastian - Providencia ( Site 0514)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Espacio Eme ( Site 0509)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)
state: Region M. De Santiago
city: Frankfurt
country: Germany
facility: InfektioResearch ( Site 1203)
state: Hessen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck ( Site 1200)
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 1206)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Novopraxis Berlin GbR ( Site 1201)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)
city: Hamburg
country: Germany
facility: Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 3205)
state: Incheon
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital ( Site 3201)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital-Department of Infectious Diseases ( Site 3209)
state: Kyonggi-do
city: Deagu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 3211)
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 3200)
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials ( Site 3102)
state: Bay Of Plenty
city: Tauranga
country: New Zealand
facility: P3 Research - Tauranga ( Site 3100)
state: Bay Of Plenty
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Ltd ( Site 3104)
state: Canterbury
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Waitemata Ltd ( Site 3105)
city: Wellington
country: New Zealand
facility: P3 Research - Wellington ( Site 3101)
city: Bayamon
country: Puerto Rico
facility: Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)
city: Caguas
country: Puerto Rico
facility: San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)
city: Canovanas
country: Puerto Rico
facility: Clinical Research Investigator Group ( Site 0611)
city: Ponce
country: Puerto Rico
facility: Ponce School Of Medicine Caimed Center ( Site 0602)
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico ( Site 0600)
city: Lund
country: Sweden
facility: ProbarE ( Site 1400)
state: Skane Lan
city: Solna
country: Sweden
facility: CTC Karolinska ( Site 1405)
state: Stockholms Lan
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB ( Site 1401)
state: Stockholms Lan
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum ( Site 1403)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: CTC MTC ( Site 1404)
state: Uppsala Lan
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 3301)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 3300)
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital ( Site 3302)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch ( Site 3303)
city: Adapazarı
country: Turkey
facility: Sakarya Training and Research Hospital ( Site 2205)
state: Sakarya
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 2204)
city: Ankara
country: Turkey
facility: Ankara City Hospital ( Site 2200)
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Platt HL, Bruno C, Buntinx E, Pelayo E, Garcia-Huidobro D, Barranco-Santana EA, Sjoberg F, Song JY, Grijalva CG, Orenstein WA, Morgan L, Fernsler D, Xu W, Waleed M, Li J, Buchwald UK; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis. 2024 Oct;24(10):1141-1150. doi: 10.1016/S1473-3099(24)00344-X. Epub 2024 Jul 1.