A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
- Conditions
- Pneumonia, Pneumococcal
- Interventions
- Registration Number
- NCT05420961
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 717
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: V116 V116 Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Cohort 2: PPSV23 PPSV23 Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Cohort 1: PCV15 PCV15 Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Cohort 3: V116 V116 Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. Cohort 1: V116 V116 Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Solicited Systemic AEs Up to 5 days post-vaccination An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) 30 Days post-vaccination OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Up to 5 days post-vaccination An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Up to ~180 days A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
- Secondary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days post-vaccination The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Geometric Mean Fold Rise of Serotype-specific IgG Day 1 (Baseline) and 30 days post-vaccination Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) Day 1 (Baseline) and 30 days post-vaccination Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses Day 1 (Baseline) and 30 days post-vaccination Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response Day 1 (Baseline) and 30 days post-vaccination Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Trial Locations
- Locations (51)
Maccabi Health Services - Holon ( Site 0305)
🇮🇱Holon, Israel
Maccabi Healthcare Services ( Site 0306)
🇮🇱Jerusalem, Israel
Meir Medical Center ( Site 0301)
🇮🇱Kfar Saba, Israel
Advanced Medical Research ( Site 0001)
🇺🇸Maumee, Ohio, United States
Hospital La Princesa ( Site 0515)
🇪🇸Madrid, Spain
EBA CENTELLES ( Site 0500)
🇪🇸Centelles, Cataluna, Spain
HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
🇪🇸Barcelona, Cataluna, Spain
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
🇰🇷Seoul, Korea, Republic of
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
🇪🇸Pozuelo de Alarcon, Madrid, Spain
National Cheng Kung University Hospital ( Site 0801)
🇨🇳Tainan, Taiwan
Lenzmeier Family Medicine/CCT Research ( Site 0008)
🇺🇸Glendale, Arizona, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
🇺🇸Tempe, Arizona, United States
Diablo Clinical Research, Inc. ( Site 0019)
🇺🇸Walnut Creek, California, United States
Southland Clinical Research Center ( Site 0026)
🇺🇸Fountain Valley, California, United States
Alliance for Multispecialty Research, LLC ( Site 0020)
🇺🇸Coral Gables, Florida, United States
Meridian Clinical Research, LLC ( Site 0009)
🇺🇸Norfolk, Nebraska, United States
Indago Research & Health Center, Inc ( Site 0005)
🇺🇸Hialeah, Florida, United States
Centennial Medical Group ( Site 0002)
🇺🇸Elkridge, Maryland, United States
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
🇺🇸Galveston, Texas, United States
Health Research of Hampton Roads, Inc. ( Site 0003)
🇺🇸Newport News, Virginia, United States
Hamilton Medical Research Group ( Site 0114)
🇨🇦Hamilton, Ontario, Canada
Milestone Research Inc. ( Site 0104)
🇨🇦London, Ontario, Canada
Manna Research Mirabel ( Site 0109)
🇨🇦Mirabel, Quebec, Canada
CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
🇨🇦Quebec City, Quebec, Canada
Diex Recherche Sherbrooke Inc. ( Site 0101)
🇨🇦Sherbrooke, Quebec, Canada
centre hospitalier lyon sud ( Site 0204)
🇫🇷Pierre-Bénite, Rhone, France
CHU Bordeaux Haut-Leveque ( Site 0202)
🇫🇷Pessac, Aquitaine, France
CHRU de Brest ( Site 0200)
🇫🇷Brest, Finistere, France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
🇫🇷Paris, France
Rambam Health Care Campus ( Site 0303)
🇮🇱Haifa, Israel
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
🇮🇱Jerusalem, Israel
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
🇮🇱Sakhnin, Israel
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
🇮🇱Ramat Gan, Israel
Ospedale San Raffaele ( Site 0403)
🇮🇹Milano, Lombardia, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
🇮🇹Milano, Lombardia, Italy
A.O.U. Policlinico Paolo Giaccone ( Site 0402)
🇮🇹Palermo, Sicilia, Italy
Gachon University Gil Medical Center ( Site 0755)
🇰🇷Namdong-gu, Incheon, Korea, Republic of
PS Clinic ( Site 0700)
🇯🇵Fukuoka, Japan
Nishikumamoto Hospital ( Site 0701)
🇯🇵Kumamoto, Japan
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
🇮🇹Foggia, Italy
Korea University Ansan Hospital ( Site 0751)
🇰🇷Ansan-si, Kyonggi-do, Korea, Republic of
Hospital Internacional Xanit ( Site 0520)
🇪🇸Benalmadena, Malaga, Spain
Hospital Universitari de Bellvitge ( Site 0505)
🇪🇸L'Hospitalet de Llobregat, Cataluna, Spain
National Taiwan University Hospital ( Site 0800)
🇨🇳Taipei, Taiwan
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 0750)
🇰🇷Seoul, Korea, Republic of
Central Research Associates ( Site 0024)
🇺🇸Birmingham, Alabama, United States
Advanced Medical Research Institute ( Site 0018)
🇺🇸Miami, Florida, United States
Solaris Clinical Research ( Site 0025)
🇺🇸Meridian, Idaho, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
🇺🇸Troy, Michigan, United States