Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633992
• Other study ID #: V116-009
• Secondary ID: jRCT2031220551
• Status: Completed
• Phase: Phase 3
• Start date: January 10, 2023
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• V116
Sterile 0.5 mL solution in prefilled syringe containing 4 µg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
• PPSV23
Sterile 0.5 mL solution in prefilled syringe containing 25 µg of each 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.

Locations

Country	Name	City	State
Japan	PS Clinic ( Site 1002)	Fukuoka
Japan	P-One Clinic ( Site 1001)	Hachioji	Tokyo
Japan	Nishikumamoto Hospital ( Site 1007)	Kumamoto
Japan	Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)	Osaka-shi	Osaka
Japan	Heishinkai Medical Group ToCROM Clinic ( Site 1004)	Shinjuku-ku	Tokyo
Japan	Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic ( Site 1003)	Suita-shi	Osaka
Japan	Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)	Toshima	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with solicited injection-site adverse events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of pain/tenderness, redness/erythema, and swelling.	Up to 5 days postvaccination
Primary	Percentage of participants with solicited systemic AEs	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of muscle aches all over body/myalgia, headache, and tiredness/fatigue.	Up to 5 days postvaccination
Primary	Percentage of participants with vaccine-related serious AEs (SAEs)	An SAE is any untoward medical occurrence that 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 an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.	Up to 30 days postvaccination
Primary	Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) [common serotypes]	The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the cross-reactive serotype 15B in V116, and the unique serotype 15C in V116, will be determined using the multiplex opsonophagocytic assay (MOPA).	Day 30 postvaccination
Primary	Percentage of participants with =4-fold rise from baseline in serotype-specific OPAs (unique to V116)	The percentage of participants with =4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) will be determined.	Baseline (Day 1) and Day 30 postvaccination
Secondary	Serotype-specific OPA GMTs (unique serotypes)	The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 will be determined using MOPA.	Day 30 postvaccination
Secondary	Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)	The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).	Day 30 postvaccination
Secondary	Percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes)	The percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.	Baseline (Day 1) and Day 30 postvaccination
Secondary	Percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs (all serotypes)	The percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs will be determined with PnECL.	Baseline (Day 1) and Day 30 postvaccination
Secondary	Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs	The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.	Baseline (Day 1) and Day 30 postvaccination
Secondary	Serotype-specific GMFR in IgG GMCs	The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.	Baseline (Day 1) and Day 30 postvaccination