V330 Vaccine for Healthy Subjects

Recruiting at 7 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Myocarditis, Pericarditis, Cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

245 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The goal of this study is to learn whether a new vaccine, V330, is safe and learn how well the body's immune system responds by making antibodies after receiving V330.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

Is in good health prior to randomization

Exclusion Criteria

I have had cancer before.

I have had myocarditis, pericarditis, or myopericarditis in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive V330 or placebo via intramuscular injection on Day 1 and Day 57

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• V330

Trial Overview The study is testing the safety and immune response of a new vaccine called V330 compared to a placebo. Participants will receive either the vaccine or an inactive substance with no therapeutic effect.

Participant Groups

Group I: Dose Expansion Panel J Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.

Group II: Dose Expansion Panel I Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.

Group III: Dose Expansion Panel E Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.

Group IV: Dose Expansion Panel D Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive a selected dose of V330 at less than or equal to DL 6 or placebo via intramuscular injection on Day 1.

Group V: Dose Escalation Panel H1 Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 4 or placebo via intramuscular injection on Day 1.

Group VI: Dose Escalation Panel H Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1.

Group VII: Dose Escalation Panel G1 Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.

Group VIII: Dose Escalation Panel G Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1.

Group IX: Dose Escalation Panel F1 Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.

Group X: Dose Escalation Panel F Experimental Treatment 2 Interventions

Participants 60 to 79 years old will be randomized to receive V330 DL 1 or placebo via intramuscular injection on Day 1.

Group XI: Dose Escalation Panel C Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive V330 DL 6 or placebo via intramuscular injection on Day 1 and Day 57.

Group XII: Dose Escalation Panel B1 Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive V330 DL 5 or placebo via intramuscular injection on Day 1.

Group XIII: Dose Escalation Panel B Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive V330 DL 3 or placebo via intramuscular injection on Day 1 and Day 57.

Group XIV: Dose Escalation Panel A1 Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive V330 DL 2 or placebo via intramuscular injection on Day 1.

Group XV: Dose Escalation Panel A Experimental Treatment 2 Interventions

Participants 18 to 49 years old will be randomized to receive V330 dose level (DL) 1 or placebo via intramuscular injection on Day 1 and Day 57.

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