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Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05425732
Recruitment Status : Completed
First Posted : June 21, 2022
Last Update Posted : June 5, 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 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

Condition or disease Intervention/treatment Phase
Pneumococcal Infection Biological: V116 Biological: PCV20 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2664 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
Actual Study Start Date : July 13, 2022
Actual Primary Completion Date : May 18, 2023
Actual Study Completion Date : May 18, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 V116
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
 Biological: V116
0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
Other Name: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: Cohort 1 PCV20
Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
 Biological: PCV20
0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Other Names:
  • Prevnar 20™
  • APEXXNAR™
Experimental: Cohort 2 V116
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
 Biological: V116
0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.
Other Name: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: Cohort 2 PCV20
Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
 Biological: PCV20
0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.
Other Names:
  • Prevnar 20™
  • APEXXNAR™


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 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 headache, muscle aches/myalgia, and tiredness/fatigue.

  3. Percentage of participants with vaccine-related serious AE (SAE) [ Time Frame: Up to 194 days postvaccination ]
    A vaccine-related SAE is any untoward medical consequence 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.

  4. Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohorts 1 and 2 for the 21 serotypes contained in V116 [ 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 in Cohort 1 for the 21 serotypes contained in V116 [ Time Frame: Baseline and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 21 serotypes contained in V116 will be determined.


Secondary Outcome Measures :
  1. Percentage of participants with ≥4-fold rise in serotype specific cross-reactive OPA responses in Cohorts 1 and 2 [ Time Frame: Baseline 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 cross-reactive OPA GMTs in Cohorts 1 and 2 [ Time Frame: Day 30 postvaccination ]
    The serotype specific OPA GMTs will be determined using MOPA.

  3. Serotype specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1 [ Time Frame: Day 30 postvaccination ]
    The GMCs for serotype specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).

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

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

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

  7. Percentage of participants with ≥4-fold rise from baseline in serotype specific OPA GMTs in Cohort 1 [ Time Frame: Baseline and Day 30 postvaccination ]
    The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs will be determined.


Eligibility Criteria
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Ages Eligible for Study:   18 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 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 PCV20, 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 administration (prior to age of 5 is acceptable) of any 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): NCT05425732


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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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05425732    
Other Study ID Numbers: V116-003
V116-003 ( Other Identifier: Merck )
2022-000258-27 ( EudraCT Number )
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: May 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
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs