V118E Vaccine for Pneumococcal Disease Prevention

Recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Pneumococcal disease, Endocrine, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, V118E, to prevent diseases caused by Streptococcus pneumoniae, a bacterium with many varieties. The trial compares V118E with an existing vaccine, PREVNAR 20™, to assess safety and tolerance. Participants will receive two doses of either V118E or PREVNAR 20™ with saline. Healthy adults without serious infections from these bacteria in the past three years may qualify for this trial. As a Phase 1 trial, this research aims to understand how the new vaccine works in people, offering participants the chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that the V118E vaccine is likely to be safe for humans?

Research has shown that current pneumococcal vaccines, such as PREVNAR 20™, are safe and typically cause no serious side effects. Although specific safety data for the new V118E vaccine is not yet available, it is currently undergoing testing in a phase 1 study. Researchers are primarily assessing its safety and tolerability in people. As this is an early-stage study, detailed safety information for V118E may not yet be available. However, since it is being compared to PREVNAR 20™, researchers hope it will exhibit a similar safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The V118E vaccine is unique because it uses a new formulation designed to enhance immune response against pneumococcal disease. Unlike standard vaccines like PREVNAR 20™, which are typically given in a single dose regimen, V118E is administered in a 2-dose regimen. This approach may offer stronger or longer-lasting protection. Researchers are excited about V118E because it could potentially provide more effective prevention of pneumococcal infections, which are a major cause of illnesses like pneumonia and meningitis.

What evidence suggests that the V118E vaccine might be an effective treatment for pneumococcal disease?

Research has shown that vaccines like V118E are designed to prevent diseases caused by the Streptococcus pneumoniae bacteria. In this trial, participants will receive either the V118E vaccine or PREVNAR 20™ in separate treatment arms. The V118E vaccine helps the body produce antibodies, proteins that combat infections, against specific types of these bacteria. Earlier vaccines for similar bacteria have proven 50% to 80% effective in preventing serious illnesses. These results suggest that V118E could provide strong protection against pneumococcal disease by enabling the immune system to fight infections effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults who are in good health before being randomly assigned to a group. There's no list of specific exclusions provided, so generally, people with underlying health conditions or those taking certain medications may not be eligible.

Inclusion Criteria

I am in good health overall.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• V118E

Trial Overview The study is testing the safety and tolerability of a new vaccine called V118E designed to prevent diseases caused by Streptococcus pneumoniae bacteria. It will be compared against PREVNAR 20™ and saline (a placebo).

How Is the Trial Designed?

Group I: V118E Experimental Treatment 1 Intervention

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

Group II: PREVNAR 20™ + Saline Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07168915

NCT07168915 | A Study of V118E in Healthy Participants ... 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 ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507794/

Pneumococcal Vaccine - StatPearls - NCBI Bookshelf The Center for Disease Control (CDC) and Advisor Committee on Immunization ... It has shown a 50% to 80% efficacy in preventing invasive pneumococcal disease in ...

3. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-025-11596-w

Real world effectiveness of antipneumococcal vaccination ... As main finding in this real-world data study, pneumococcal vaccination did not prove effective (neither PPsV23 nor PCV13) in preventing ...

4. mdpi.com mdpi.com/2076-0817/12/5/732

Systematic Review and Meta-Analysis of the Efficacy ... Only one RCT (CAPITA) was identified, with a reported efficacy of 75% (95% CI: 41%, 91%) against PCV13-type IPD in Dutch pneumococcal vaccine-naïve, community- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8063798/

Pneumococcal Disease Prevention: Are We on the Right ... Moreover, the new PCVs showed little effectiveness in the prevention of infection due to non-encapsulated STs and to ST3. Next-generation S. pneumoniae vaccines ...

6. patlynk.com patlynk.com/trial/NCT07168915

Safety and Immunogenicity of V118E Vaccine in Healthy ... 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 ...

7. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2025-8534e

V118E Vaccine for Pneumococcal Disease Prevention The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.

8. cdc.gov cdc.gov/vaccine-safety/vaccines/pneumococcal.html

Pneumococcal Vaccine Safety A closer look at the safety data · A 2004 study of VAERS data found that most adverse events reported during the first two years after licensure ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12417412/

Post-marketing safety surveillance of pneumococcal vaccines Current pharmacovigilance data demonstrate well-established safety profiles in adolescent and adult populations receiving these immunizations.