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Safety and Immunogenicity of V118E Vaccine in Healthy Adults

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What is being tested

V118E

+ PREVNAR 20™
+ Saline
Biological
Who is being recruted

Healthy

From 18 to 49 Years
+3 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: October 30, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 8, 2025Actual date on which the first participant was enrolled.

Researchers are conducting a study to test a new vaccine, called V118E, which may help prevent illnesses caused by the bacteria Streptococcus pneumoniae. This bacteria has many different types known as serotypes. Vaccines usually include small parts of these serotypes to train the immune system to fight off infections without causing illness. The study aims to see how safe this new vaccine is and how well healthy adults can tolerate it. This research is important because it could lead to better protection against diseases caused by this bacteria, which can lead to serious health issues. In this study, healthy adult participants will receive the V118E vaccine to evaluate its safety and how well it is tolerated. The vaccine is likely administered through an injection. Researchers will monitor the participants for any side effects or reactions to the vaccine to ensure it is safe. The study does not detail specific risks or benefits but focuses on the safety and immune response to the vaccine. By understanding these factors, researchers hope to develop a vaccine that can effectively prevent illnesses caused by Streptococcus pneumoniae.

Official TitleA Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults 
Principal SponsorMerck Sharp & Dohme LLC
Study ContactToll Free Number
Last updated: October 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
126 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 49 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy
Criteria
1 inclusion criteria required to participate
Is in good health before randomization
2 exclusion criteria prevent from participating
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
Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29.
Group II
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.
Study Objectives
Primary Objectives

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.

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.

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.

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.

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.

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.

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.
Secondary Objectives

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

Change from baseline in GMCs for serotype-specific IgG antibodies will be determined using Pn ECL assay.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Recruiting
Velocity Clinical Research, Hallandale Beach ( Site 0003)Hallandale, United StatesSee the location
Recruiting
QPS-MRA, LLC-Early Phase ( Site 0002)South Miami, United States
Recruiting
University of Texas Medical Branch ( Site 0001)Galveston, United States
Recruiting
3 Study Centers