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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05425732
Collaborator
(none)
2,600
68
4
11
38.2
3.5

Study Details

Study Description

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. 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
  • Biological: V116
  • Biological: PCV20
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2600 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 :
Jul 13, 2022
Anticipated Primary Completion Date :
Jun 13, 2023
Anticipated Study Completion Date :
Jun 13, 2023

Arms and Interventions

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
Sterile 0.5 mL 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.

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
Sterile 0.5 mL 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
    Sterile 0.5 mL 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.

    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
    Sterile 0.5 mL 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

    Primary Outcome Measures

    1. Percentage of participants with solicited injection-site AEs [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 [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) [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 Cohort 1 for the 21 serotypes contained in V116 [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 for the 21 serotypes contained in V116 [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. Serotype-specific OPA GMTs in Cohorts 1 and 2 [Day 30 postvaccination]

      The serotype-specific OPA GMTs will be determined using MOPA.

    2. Percentage of participants with ≥4-fold rise in serotype-specific cross-reactive OPA responses in Cohorts 1 and 2 [Day 30 postvaccination]

      The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs will be determined.

    3. Serotype-specific cross-reactive OPA GMTs in Cohorts 1 and 2 [Day 30 postvaccination]

      The serotype-specific OPA GMTs will be determined using MOPA.

    4. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1 [Day 30 postvaccination]

      The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL).

    5. Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs in Cohort 1 [Baseline and Day 30 postvaccination]

      The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.

    6. GMFR from baseline in serotype-specific IgG GMCs in Cohort 1 [Baseline and Day 30 postvaccination]

      The GMFR 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 IgG GMCs in Cohort 1 [Baseline and Day 30 postvaccination]

      The GMFR in GMCs for serotype-specific IgG antibodies will be determined using PnECL.

    8. Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs in Cohort 1 [Baseline and Day 30 postvaccination]

      The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs will be determined.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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
    • 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

    Locations

    Site City State Country Postal Code
    1 Central Research Associates ( Site 0067) Birmingham Alabama United States 35205
    2 Lenzmeier Family Medicine/CCT Research ( Site 0006) Glendale Arizona United States 85308
    3 Desert Clinical Research/ CCT Research ( Site 0040) Mesa Arizona United States 85213
    4 Foothills Research Center/ CCT Research ( Site 0021) Phoenix Arizona United States 85044
    5 Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003) Tempe Arizona United States 85283
    6 Baptist Health Center For Clinical Research ( Site 0019) Little Rock Arkansas United States 72205
    7 Southland Clinical Research Center-Research ( Site 0054) Fountain Valley California United States 92708
    8 Sunwise Clinical Research ( Site 0024) Lafayette California United States 94549
    9 Chemidox Clinical Trials ( Site 0048) Lancaster California United States 93534
    10 Paradigm Clinical Research Centers, Inc ( Site 0018) Redding California United States 96001
    11 Peninsula Research Associates ( Site 0079) Rolling Hills Estates California United States 90274
    12 Acclaim Clinical Research ( Site 0083) San Diego California United States 92120
    13 Millennium Clinical Trials ( Site 0013) Simi Valley California United States 93065
    14 Lynn Institute of Denver ( Site 0012) Aurora Colorado United States 80012
    15 Paradigm Clinical Research Centers, Inc ( Site 0027) Wheat Ridge Colorado United States 80033
    16 JEM Research Institute ( Site 0072) Atlantis Florida United States 33462
    17 Alliance for Multispecialty Research, LLC ( Site 0015) Coral Gables Florida United States 33134
    18 Hillcrest Medical Research ( Site 0049) DeLand Florida United States 32720
    19 East Coast Institute for Research, LLC ( Site 0070) Jacksonville Florida United States 32204
    20 L&C Professional Medical Research Institute ( Site 0025) Miami Florida United States 33144
    21 Advanced Medical Research Institute ( Site 0014) Miami Florida United States 33174
    22 Headlands Research Orlando ( Site 0031) Orlando Florida United States 32819
    23 Genesis Clinical Research ( Site 0016) Tampa Florida United States 33603
    24 Clinical Research Trials of Florida ( Site 0007) Tampa Florida United States 33607
    25 Palm Beach Research Center ( Site 0060) West Palm Beach Florida United States 33409
    26 Clinical Research Prime ( Site 0010) Idaho Falls Idaho United States 83404
    27 Solaris Clinical Research ( Site 0008) Meridian Idaho United States 83646
    28 Versailles Family Medicine / CCT Research ( Site 0063) Versailles Kentucky United States 40383
    29 Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038) Troy Michigan United States 48098
    30 Healor Primary Care / CCT Research ( Site 0056) Las Vegas Nevada United States 89102
    31 Excel Clinical Research, LLC ( Site 0077) Las Vegas Nevada United States 89109
    32 Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029) Las Vegas Nevada United States 89119
    33 Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032) Horseheads New York United States 14845
    34 Aventiv Research Inc ( Site 0044) Columbus Ohio United States 43213
    35 Advanced Medical Research ( Site 0002) Maumee Ohio United States 43537
    36 Lynn Institute of Norman ( Site 0001) Norman Oklahoma United States 73072
    37 Lynn Institute of Tulsa ( Site 0084) Tulsa Oklahoma United States 74135
    38 Summit Headlands ( Site 0047) Portland Oregon United States 97210
    39 Velocity Clinical Research, Greenville ( Site 0043) Greenville South Carolina United States 29615
    40 Trial Management Associates ( Site 0089) Myrtle Beach South Carolina United States 29572
    41 Tekton Research, Inc. ( Site 0053) Austin Texas United States 78745
    42 Elixir Research Group - W Houston ( Site 0068) Houston Texas United States 77077
    43 DCOL Center for Clinical Research ( Site 0051) Longview Texas United States 75605
    44 IMA Clinical Research San Antonio ( Site 0009) San Antonio Texas United States 78229
    45 VIP Trials ( Site 0086) San Antonio Texas United States 78230
    46 Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036) Tomball Texas United States 77375
    47 Charlottesville Medical Research ( Site 0034) Charlottesville Virginia United States 22911
    48 Health Research of Hampton Roads, Inc. ( Site 0004) Newport News Virginia United States 23606
    49 MultiCare Rockwood Cheney Clinic ( Site 0037) Spokane Washington United States 99204
    50 Paratus Clinical Research Canberra ( Site 3000) Bruce Australian Capital Territory Australia 2617
    51 Emeritus Research ( Site 3004) Botany New South Wales Australia 2019
    52 Paratus Clinical Research Central Coast ( Site 3001) Kanwal New South Wales Australia 2259
    53 Westmead Hospital ( Site 3005) Westmead New South Wales Australia 2145
    54 Emeritus Research ( Site 3003) Camberwell Victoria Australia 3124
    55 InfektioResearch ( Site 1203) Frankfurt Hessen Germany 60596
    56 Hamburger Institut fuer Therapieforschung GmbH ( Site 1204) Hamburg Germany 20354
    57 Lakeland Clinical Trials ( Site 3102) Rotorua Bay Of Plenty New Zealand 3010
    58 P3 Research - Tauranga ( Site 3100) Tauranga Bay Of Plenty New Zealand 3110
    59 Southern Clinical Trials Ltd ( Site 3104) Christchurch Canterbury New Zealand 8013
    60 Southern Clinical Trials Waitemata Ltd ( Site 3105) Auckland New Zealand 0626
    61 P3 Research - Wellington ( Site 3101) Wellington New Zealand 6021
    62 Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601) Bayamon Puerto Rico 00961
    63 San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606) Caguas Puerto Rico 00725
    64 Clinical Research Investigator Group ( Site 0611) Canovanas Puerto Rico 00729
    65 Ponce School Of Medicine Caimed Center ( Site 0602) Ponce Puerto Rico 00716
    66 Clinical Research Puerto Rico ( Site 0600) San Juan Puerto Rico 00909
    67 National Cheng Kung University Hospital ( Site 3301) Tainan Taiwan 704
    68 Chang Gung Medical Foundation-Linkou Branch ( Site 3303) Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp and Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT05425732
    Other Study ID Numbers:
    • V116-003
    • V116-003
    • 2022-000258-27
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2022