Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

NCT04665050 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: pPCV-002jRCT2071200094V116-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

  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 included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.

  Up to 5 days postvaccination

• Percentage of Participants With a Solicited Systemic AE

  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 included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.

  Up to 5 days postvaccination

• Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

  An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.

  Up to 62 days postvaccination

Secondary Outcomes (6)

• Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23

  Day 30 postvaccination

• Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23

  Day 30 postvaccination

• Serotype-specific OPA GMTs for the Unique Serotypes in V116

  Day 30 postvaccination

• Serotype-specific IgG GMCs for the Unique Serotypes in V116

  Day 30 postvaccination

• Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

  Baseline (Day 1) and Day 30 postvaccination

Study Arms (2)

V116

EXPERIMENTAL

Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.

Biological: V116

PNEUMOVAX™23

ACTIVE COMPARATOR

Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.

Biological: PNEUMOVAX™23

Interventions

V116 BIOLOGICAL

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following 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

Also known as: Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine

V116

PNEUMOVAX™23 BIOLOGICAL

Pneumococcal 23-valent polyvalent 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

Also known as: PPSV23

PNEUMOVAX™23

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is a healthy Japanese male or female ≥20 years of age at time of randomization
• male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
• female participants must not be pregnant or breastfeeding, and is either:
• not a woman of childbearing potential (WOCBP) or
• a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention

You may not qualify if:

• has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
• has a known hypersensitivity to any vaccine components
• has impaired immunological function
• has a coagulation disorder
• had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
• has a known malignancy that is progressing/requiring treatment
• has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
• has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
• is receiving immunosuppressive therapy
• has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
• has received any live vaccine from 30 days prior to Day 1
• has received a blood transfusion or blood products
• has participated in another clinical trial within 2 months of this study
• has clinically relevant drug or alcohol abuse
• has any condition that, in the opinion of the investigator, precludes participation in this study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Souseikai PS Clinic ( Site 0201)

Fukuoka, 812-0025, Japan

Location

Souseikai Nishikumamoto Hospital ( Site 0202)

Kumamoto, 861-4157, Japan

Location

Related Publications (1)

• Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.

  PMID: 37389808 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 11, 2020
• Study Start: February 4, 2021
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: October 4, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (2)