V330 Vaccine for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine called V330 to determine its safety and ability to help the body produce antibodies, which are proteins that fight germs. The study involves different groups receiving various doses of V330 or a placebo (a harmless substance with no effect) to compare results. It seeks healthy individuals aged 18 to 49 or 60 to 79. Participants should not have a history of heart inflammation or cancer. As a Phase 1 trial, participants will be among the first to receive this new treatment, contributing to understanding its effects in people.
Do I need to stop taking my current medications for the V330 vaccine trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that the V330 vaccine is likely to be safe for humans?
Research shows that earlier studies of the V330 vaccine have found it to be safe. Participants generally tolerated the vaccine well. Reports of unwanted effects were low, and when they occurred, they were usually mild. This indicates that serious negative effects were uncommon. These findings suggest that the V330 vaccine is likely safe for humans. However, since this trial is in an early stage, researchers continue to closely monitor safety as they test different doses.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the V330 vaccine because it represents a new approach in preventative care by potentially offering protection through a novel formulation. Unlike traditional vaccines that use weakened or inactivated pathogens, V330 is designed with a unique dosage strategy that is being carefully tested across various age groups to maximize effectiveness and safety. This tailored dosing could lead to better immune responses in different age demographics, which is a significant step forward compared to one-size-fits-all vaccines. Additionally, the vaccine's intramuscular delivery method is a standard approach that helps ensure consistent absorption and efficacy.
What evidence suggests that the V330 vaccine could be effective?
Research shows that vaccines like V330 have potential to boost the immune system. Studies on similar vaccines have demonstrated about 61.8% effectiveness in preventing moderate to severe illnesses caused by norovirus. This trial will test various doses of V330 to determine its effectiveness in helping the body produce protective antibodies. While specific data on V330's effectiveness is not yet available, it is based on proven vaccine methods. Early signs are promising, but further research is needed to confirm its effectiveness.13678
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 individuals, aged between 18-49 or 60-79. Specific criteria to join or reasons that might disqualify someone from participating are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive V330 or placebo via intramuscular injection on Day 1 and Day 57
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- V330
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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