Clinical trial NCT05633992: Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
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 Japanese Adults 65 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: 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 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).


Eligibility criteria: Inclusion Criteria:

* Is Japanese
* For females, is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) or is a POCBP and uses acceptable contraception/abstinence; has a negative highly sensitive pregnancy test (urine or serum) within 24 (urine) or 72 (serum) hours before the first dose of study intervention; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion 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 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 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 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 postvaccination
measure: Percentage of Participants With Solicited Systemic AEs
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With Vaccine-related Serious AEs (SAEs)
timeFrame: Up to 30 days postvaccination
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
timeFrame: Day 30 postvaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Secondary outcomes:
measure: Serotype-specific OPA GMTs (Unique Serotypes)
timeFrame: Day 30 postvaccination
measure: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
timeFrame: Day 30 postvaccination
measure: Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Serotype-specific GMFR in IgG GMCs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Other outcomes:
Locations:
city: Osaka-shi
country: Japan
facility: Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic ( Site 1003)
state: Osaka
city: Hachioji
country: Japan
facility: P-One Clinic ( Site 1001)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic ( Site 1004)
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)
state: Tokyo
city: Toshima
country: Japan
facility: Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)
state: Tokyo
city: Fukuoka
country: Japan
facility: PS Clinic ( Site 1002)
city: Kumamoto
country: Japan
facility: Nishikumamoto Hospital ( Site 1007)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: