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Completed

NCT Number: NCT05420961

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

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Key information

Conditions

Pneumonia, Pneumococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Pneumococcal Infections Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Medical Research Group ( Site 0114), Hamilton, Ontario, Canada

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About this study

Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

  • Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

Exclusion criteria

  • Has a history of invasive pneumococcal disease (IPD).
  • Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
  • Has a known malignancy that is progressing or has required active treatment.
  • Has received PPSV23 followed by either PCV15 or PCV20.
  • Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
  • 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 any study vaccine.
  • Has 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.
  • Has 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 post-vaccination blood draw is complete.

Treatment and study plan

V116

Biological

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Other names: Pneumococcal 21-valent Conjugate Vaccine

PCV15

Biological

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension

Other names: VAXNEUVANCE™

PPSV23

Biological

Pneumococcal 23-valent vaccine with 25 μg of each of the 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 names: PNEUMOVAX™23

Primary outcomes

  1. Percentage of Participants With Solicited Injection-site Adverse Events (AEs)

    Time frame: Up to 5 days post-vaccination

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.

  2. Percentage of Participants With Solicited Systemic AEs

    Time frame: Up to 5 days post-vaccination

    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.

  3. Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

    Time frame: Up to ~180 days

    A serious adverse event (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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.

  4. Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)

    Time frame: 30 Days post-vaccination

    OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.

Secondary outcomes

  1. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)

    Time frame: 30 Days post-vaccination

    The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.

  2. Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)

    Time frame: Day 1 (Baseline) and 30 days post-vaccination

    Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.

  3. Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses

    Time frame: Day 1 (Baseline) and 30 days post-vaccination

    Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.

  4. Geometric Mean Fold Rise of Serotype-specific IgG

    Time frame: Day 1 (Baseline) and 30 days post-vaccination

    Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.

  5. Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response

    Time frame: Day 1 (Baseline) and 30 days post-vaccination

    Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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