Safety and Immunogenicity of V118E Vaccine in Healthy Adults
V118E
+ PREVNAR 20™
+ Saline
Prevention Study
Summary
Study start date: October 8, 2025
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.126 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 49 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
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 4 locations
QPS-MRA, LLC-Early Phase ( Site 0002)
South Miami, United StatesBio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0004)
Springfield, United StatesUniversity of Texas Medical Branch ( Site 0001)
Galveston, United States