MedTrace Logo

A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)

NCT04498247 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2021-12-23

Study results available
· View outcomes & findings →

Summary

The primary objective of this early Phase 1/2 study is to identify the V591 dose that achieves the target immune response in humans based on preclinical or early clinical data.

Conditions

  • Coronavirus Disease (COVID-19)

Interventions

BIOLOGICAL

V591

1 or 2 ascending doses of V591 will be administered via intramuscular (IM) injection.

OTHER

Placebo

Placebo (0.9% sodium chloride) administered via IM injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2021-03-05
Completion
2021-03-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498247 on ClinicalTrials.gov