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Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

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ClinicalTrials.gov Identifier: NCT05569954
Recruitment Status : Active, not recruiting
First Posted : October 6, 2022
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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 adults 50 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 that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: V116 Biological: PPSV23 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1484 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 50 Years of Age or Older
Actual Study Start Date : November 7, 2022
Actual Primary Completion Date : October 30, 2023
Estimated Study Completion Date : April 2, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: V116 Treatment
Participants receive a single intramuscular (IM) injection of V116 on Day 1.
 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.
Other Name: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: PPSV23 Treatment
Participants receive a single IM injection of PPSV23 on Day 1.
 Biological: 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.
Other Name: PNEUMOVAX™23


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with solicited injection-site AEs [ Time Frame: Up to 5 days postvaccination ]
    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 consisted of pain/tenderness, redness/erythema, and swelling.

  2. Percentage of participants with solicited systemic AEs [ Time Frame: Up to 5 days postvaccination ]
    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.

  3. Percentage of participants with vaccine-related serious AE (SAE) [ Time Frame: Up to 6 months postvaccination ]
    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.

  4. Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) [ Time Frame: Day 30 postvaccination ]
    The serotype-specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA).

  5. Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs (unique to V116) [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique serotypes contained in V116 will be determined.


Secondary Outcome Measures :
  1. Percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs will be determined.

  2. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) [ Time Frame: Day 30 postvaccination ]
    The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).

  3. Serotype-specific geometric mean fold rise (GMFR) in OPA GMTs [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.

  4. Serotype-specific GMFR in IgG GMCs [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.

  5. Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs (all serotypes) [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.

  6. Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs [ Time Frame: Baseline (Day 1) and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; 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
Contacts and Locations
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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): NCT05569954


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05569954    
Other Study ID Numbers: V116-010
2022-001785-35 ( EudraCT Number )
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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