A Study of V118E in Healthy Participants (V118E-003)

NCT07168915 | Recruiting Phase 1 FDA Drug

• 1 other identifier: V118E-003
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

Brief Summary

Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria. PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria. The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Solicited Injection-Site Adverse Events (AEs)

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their vaccine report card (VRC). Solicited injection-site AEs include redness, swelling, and pain or tenderness. The number of participants with a solicited injection-site AE will be reported.

  Up to approximately 7 days after each vaccination

• Number of Participants With Solicited Systemic AEs

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their VRC. Solicited systemic AEs include fever, muscle aches all over body, joint pain, headache, and tiredness. The number of participants with a solicited systemic AE will be reported.

  Up to approximately 7 days after each vaccination

• Number of Participants With Immediate AEs Following Vaccination

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. The number of participants with immediate AEs following vaccination will be reported.

  Up to approximately 30 minutes after each vaccination

• Number of Participants With Unsolicited AEs

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. An unsolicited AE is an event that is not solicited using a VRC and that is communicated by a participant. The number of participants who experience an unsolicited AE will be reported.

  Up to approximately 28 days after each vaccination

• Number of Participants With a Serious Adverse Event (SAE)

  An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.

  Up to approximately 12 months after final vaccination

• Number of Participants With a Medically Attended Adverse Event (MAAE)

  A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience a MAAE will be reported.

  Up to approximately 12 months after final vaccination

• Number of Participants With an Adverse Events of Special Interest (AESI)

  AESIs are selected serious and nonserious AEs which include but are not limited to: 1) Potential drug-induced liver injury (DILI) events defined as an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is ≥3\* the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is ≥2\* the ULN and, at the same time, an alkaline phosphatase laboratory value that is \<2\* the ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 2) an overdose of V118E. 3) Potential immune-mediated disease (pIMDs) defined as a subset of AEs that an established autoimmune disease(s) AND inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an AESI will be reported.

  Up to approximately 12 months after final vaccination

Secondary Outcomes (2)

• Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)

  Day 28 Postvaccination 1

• Change From Baseline in Serotype-specific IgG GMCs

  Baseline and Day 28 Postvaccination 1

Study Arms (2)

V118E

EXPERIMENTAL

Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29.

Biological: V118E

PREVNAR 20™ + Saline

ACTIVE COMPARATOR

Participants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.

Biological: PREVNAR 20™; Biological: Saline

Interventions

V118E BIOLOGICAL

IM administration

Also known as: V118/VA-017

V118E

PREVNAR 20™ BIOLOGICAL

IM administration

PREVNAR 20™ + Saline

Saline BIOLOGICAL

IM administration

PREVNAR 20™ + Saline

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Is in good health before randomization

You may not qualify if:

• Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
• Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (4)

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, 33009, United States

RECRUITING

QPS-MRA, LLC-Early Phase ( Site 0002)

South Miami, Florida, 33143, United States

RECRUITING

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004)

Springfield, Missouri, 65802, United States

RECRUITING

University of Texas Medical Branch ( Site 0001)

Galveston, Texas, 77555-1115, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

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

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): November 12, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (4)