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A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

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ClinicalTrials.gov Identifier: NCT05464420
Recruitment Status : Completed
First Posted : July 19, 2022
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.

The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.


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 : 2162 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, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
Actual Study Start Date : August 12, 2022
Actual Primary Completion Date : May 25, 2023
Actual Study Completion Date : May 25, 2023

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 Lot 1
Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
 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
Experimental: V116 Lot 2
Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
 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
Experimental: V116 Lot 3
Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
 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
Active Comparator: PPSV23
Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
 Biological: PPSV23
Pneumococcal 23-valent conjugate 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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with solicited injection-site adverse events (AEs) [ Time Frame: Up to ~5 days ]
    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 include pain/tenderness, redness/erythema, and swelling.

  2. Percentage of participants with solicited systemic AEs [ Time Frame: Up to ~5 days ]
    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 include headache, muscle aches/myalgia, and tiredness/fatigue.

  3. Percentage of participants with vaccine-related serious adverse events (SAEs) [ Time Frame: Up to ~6 months ]
    An SAE is any untoward medical occurrence that, at any dose, 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 another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination will be summarized.

  4. Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116 [ Time Frame: Day 30 ]
    Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using multiplex opsonophagocytic assay (MOPA).


Secondary Outcome Measures :
  1. GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ [ Time Frame: Day 30 ]
    Serotype-specific OPA GMT for all serotypes in V116 following vaccination will be determined using MOPA.

  2. Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots [ Time Frame: Day 30 ]
    Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using pneumococcal electrochemiluminescence (PnECL).

  3. GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAX™ [ Time Frame: Day 30 ]
    Serotype-specific IgG GMC for all serotypes in V116 following vaccination will be determined using PnECL.

  4. Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
    Serotype-specific OPA GMFR for all serotypes in V116 following vaccination will be determined using MOPA.

  5. Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
    Percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination will be reported.

  6. GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
    Serotype-specific IgG GMFR for all serotypes in V116 following vaccination will be determined using PnECL.

  7. Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots [ Time Frame: Baseline (Day 1) and Day 30 ]
    Percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination will be reported.

  8. GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots [ Time Frame: Day 30 ]
    Serotype-specific OPA GMTs for cross-reactive serotypes following vaccination will be determined using MOPA.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Has underlying chronic conditions but assessed to be stable as per investigator
  • Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator

Exclusion Criteria:

  • Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
  • Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
  • Has a coagulation disorder contraindicating intramuscular vaccination
  • Has a recent illness with fever
  • Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
  • Is expected to receive any pneumococcal vaccine during the study outside of the protocol
  • Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
  • Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
  • Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
  • Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
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): NCT05464420


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: NCT05464420    
Other Study ID Numbers: V116-004
2022-000265-41 ( EudraCT Number )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: March 4, 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

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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