HealthyPhase 1NCT07168915
A Study of V118E in Healthy Participants (V118E-003)
A Phase 1 study testing V118E, PREVNAR 20™ and Saline in people with Healthy, run by Merck Sharp & Dohme LLC at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- V118E, PREVNAR 20™ and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Oct 2025to 6 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health before randomization
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Medical Branch ( Site 0001)
Galveston, Texas, 77555-1115
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, 33009
QPS-MRA, LLC-Early Phase ( Site 0002)
South Miami, Florida, 33143
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004)
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation E in Healthy Adults
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
- Being tested
- V118E, PREVNAR 20™, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V118EBiological
Also called V118/VA-017
IM administration
PREVNAR 20™Biological
IM administration
SalineBiological
IM administration
| Study group | Role | What they receive |
|---|---|---|
| V118E | Experimental | Participants receive intramuscular (IM) injection of V118E in a 2-dose regimen administered on Day 1 and Day 29. Receives: 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. Receives: Biological: PREVNAR 20™; Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 12 months after final vaccination
Secondary outcomes (2)
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay.
Measured: Day 28 Postvaccination 1
Change From Baseline in Serotype-specific IgG GMCs
Change from baseline in GMCs for serotype-specific IgG antibodies will be determined using Pn ECL assay.
Measured: Baseline and Day 28 Postvaccination 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start8 Oct 2025
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168915
- Sponsor's protocol ID
- V118E-003
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf