Trial record 1 of 10 for:
V116, PPSV23 | Pneumococcal Disease
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8)
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| ClinicalTrials.gov Identifier: NCT05696080 |
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Recruitment Status :
Completed
First Posted : January 25, 2023
Last Update Posted : February 28, 2024
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumococcal Infection | Biological: V116 Drug: Placebo for PCV15 + PPSV23 Biological: PCV15 Biological: PPSV23 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 518 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | February 13, 2023 |
| Actual Primary Completion Date : | February 16, 2024 |
| Actual Study Completion Date : | February 16, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: V116
Participants will receive a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo for PCV15 + PPSV23 on Week 8
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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
Other Name: Pneumococcal 21-valent Conjugate Vaccine Drug: Placebo for PCV15 + PPSV23 Saline in each 0.5 mL sterile solution |
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Active Comparator: PCV15 + PPSV23
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
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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
Other Name: VAXNEUVANCE™ Biological: 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
Other Name: PNEUMOVAX™23 |
Primary Outcome Measures :
- Participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 post-vaccination [ Time Frame: Up to Day 5 ]Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 post-vaccination
- Participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination [ Time Frame: Up to Day 5 ]Percentage of participants with solicited systemic AEs from Day 1 through Day 5 post-vaccination
- Participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study [ Time Frame: Up to Month 6 ]Percentage of participants with vaccine-related SAEs from Day 1 through the duration of participation in the study
- Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) post-vaccination [ Time Frame: Up to Week 12 ]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])
Secondary Outcome Measures :
- Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) post-vaccination [ Time Frame: Up to Week 12 ]Serotype-specific IgG GMCs post-vaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)
- Serotype-specific geometric mean fold rises (GMFRs) from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses [ Time Frame: Baseline and up to Week 12 ]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
- Serotype-specific GMFRs from baseline to post-vaccination with V116 and PCV15 + PPSV2 for Immunoglobulin G (IgG) responses [ Time Frame: Baseline and up to Week 12 ]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
- Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPSV2 for OPA responses [ Time Frame: Baseline and up to Week 12 ]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
- Serotype-specific percentage of participants with a ≥4-fold rise from baseline to post-vaccination with V116 and PCV15 + PPS for IgG responsesV2 [ Time Frame: Baseline and up to Week 12 ]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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05696080
Locations
Show 44 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Clinical Director | Merck Sharp & Dohme LLC |
Additional Information:
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT05696080 |
| Other Study ID Numbers: |
V116-008 V116-008 ( Other Identifier: Merck ) jRCT2061220106 ( Registry Identifier: jRCT ) |
| First Posted: | January 25, 2023 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |