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

Pneumococcal Infection Clinical Trial

— STRIDE-8  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05696080
• Other study ID #: V116-008
• Secondary ID: V116-008jRCT2061
• Status: Completed
• Phase: Phase 3
• Start date: February 13, 2023
• Est. completion date: February 16, 2024

Study information

• Verified date: February 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: February 16, 2024
• Est. primary completion date: February 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Infection
• Pneumococcal Infections

Intervention

Biological:
• 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

Drug:
• Placebo for PCV15 + PPSV23
Saline in each 0.5 mL sterile solution

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
• 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

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital ( Site 0400)	Brisbane	Queensland
Australia	Holdsworth House Medical Practice ( Site 0402)	Darlinghurst	New South Wales
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	G A Research Associates ( Site 0100)	Moncton	New Brunswick
Canada	Clinique de médecine Urbaine du Quartier Latin ( Site 0111)	Montreal	Quebec
Canada	Diex Recherche Trois-Rivieres ( Site 0110)	Trois-Rivieres	Quebec
Canada	Diex Recherche Victoriavile Inc. ( Site 0102)	Victoriaville	Quebec
Chile	Universidad San Sebastian - Providencia ( Site 1003)	Providencia	Region M. De Santiago
Chile	Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)	Santiago	Region M. De Santiago
Chile	Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)	Santiago	Region M. De Santiago
Chile	CESFAM Esmeralda ( Site 1009)	Santiago	Region M. De Santiago
Chile	Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)	Santiago	Region M. De Santiago
Chile	Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)	Talca	Maule
Chile	Hospital Dr. Hernán Henríquez Aravena ( Site 1001)	Temuco	Araucania
Japan	Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)	Kurume	Fukuoka
Japan	Shimonoseki Medical Center ( Site 0201)	Shimonoseki	Yamaguchi
Korea, Republic of	Hallym University Sacred Heart Hospital ( Site 0303)	Anyang-si	Kyonggi-do
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital ( Site 0301)	Seoul
Korea, Republic of	Konkuk University Medical Center ( Site 0302)	Seoul
Korea, Republic of	Korea University Anam Hospital ( Site 0305)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 0300)	Seoul
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
New Zealand	Pacific Clinical Research Network - Rotorua ( Site 0500)	Rotorua	Bay Of Plenty
New Zealand	P3 Research - Tauranga ( Site 0507)	Tauranga	Bay Of Plenty
New Zealand	P3 Research - Wellington ( Site 0503)	Wellington
Poland	Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)	Bydgoszcz	Kujawsko-pomorskie
Poland	IN VIVO ( Site 0601)	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Medyczne Pratia Katowice ( Site 0604)	Katowice	Slaskie
Poland	Clinical Medical Research ( Site 0605)	Katowice	Slaskie
Poland	Centrum Medyczne Medyk ( Site 0602)	Rzeszow	Podkarpackie
Poland	Clinmedica Research Sp. z. o. o. ( Site 0603)	Skierniewice	Lodzkie
Poland	MICS Centrum Medyczne Torun ( Site 0606)	Torun	Kujawsko-pomorskie
United States	EmVenio Research ( Site 0018)	Fort Worth	Texas
United States	Indago Research & Health Center, Inc ( Site 0002)	Hialeah	Florida
United States	Holston Medical Group ( Site 0010)	Kingsport	Tennessee
United States	Aventiv Research ( Site 0022)	Mesa	Arizona
United States	Mid Hudson Medical Research ( Site 0008)	New Windsor	New York
United States	SKY Integrative Medical Center/SKYCRNG ( Site 0012)	Ridgeland	Mississippi
United States	Wenatchee Valley Hospital ( Site 0019)	Wenatchee	Washington
United States	Triple O Research Institute, P.A ( Site 0011)	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Japan,  Korea, Republic of,  New Zealand,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination	Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination	Up to Day 5
Primary	Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination	Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination	Up to Day 5
Primary	Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study	Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study	Up to Month 6
Primary	Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination	Serotype-specific OPA GMTs post-vaccination with V116 (30 days post-vaccination [Day 30]) or PCV15 + PPSV23 (30 days post-vaccination with the final dose in the regimen [Week 12])	Up to Week 12
Secondary	Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination	Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)	Up to Week 12
Secondary	Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses	Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post=vaccination with PCV15 + PPSV2 (Week 12) for OPA responses	Baseline and up to Week 12
Secondary	Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses	Serotype-specific GMFRs from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV23 (Week 12) for IgG responses	Baseline and up to Week 12
Secondary	Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses	Serotype-specific percentage of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for OPA responses	Baseline and up to Week 12
Secondary	Serotype-specific percentage of participants with a =4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2	Serotype-specific proportion of participants with a =4-fold rise from baseline (Day 1) to post-vaccination with V116 (Day 30) and from baseline (Day 1) to post-vaccination with PCV15 + PPSV2 (Week 12) for IgG responses	Baseline and up to Week 12

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary