A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: V330

Study type: Interventional

Funder types: Industry

Identifiers

NCT06630117

V330-001

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

• Is in good health prior to randomization
• Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

• Has a history of myocarditis, pericarditis, and/or myopericarditis
• Has a history of cancer

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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245 participants in 15 patient groups

Dose Escalation Panel A

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel B

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel C

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Expansion Panel D

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Expansion Panel E

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel F

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel G

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel H

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Expansion Panel I

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Expansion Panel J

Experimental group

Description:

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.

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel A1

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel B1

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel F1

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel G1

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo

Dose Escalation Panel H1

Experimental group

Description:

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

Treatment:

Biological: V330

Biological: Placebo