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Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)

NCT04569786 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2021-12-29

Study results available
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Summary

The primary objective of this study is to evaluate the safety and tolerability of V590 versus placebo and to assess the immunogenicity of V590 on Day 28. The primary hypothesis is that at least one well-tolerated dose of V590 increases the geometric mean titers (GMTs) of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike serum neutralizing antibody, as measured by plaque reduction neutralization test (PRNT), compared to placebo.

Conditions

  • Coronavirus Disease (COVID-19)

Interventions

BIOLOGICAL

V590

Single dose of V590 administered via intramuscular (IM) injection with dosage levels of 5.00x10\^5 pfu/mL (Panels A, E), 2.40x10\^6 pfu/mL (Panels B,F), 1.15x10\^7 pfu/mL (Panels C, G), 5.55x10\^7 pfu/mL (Panels D, H, I).

OTHER

Placebo

Placebo administered via IM injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-29
Primary Completion
2021-02-18
Completion
2021-02-18
FDA Drug
Yes

Countries

  • United States

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 NCT04569786 on ClinicalTrials.gov