NCT04569786

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of V590 in Healthy Adults

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study was terminated and study objectives, endpoints, and procedures were modified accordingly via Protocol Amendment 03. Analysis included the intervention doses (V590 5.00 x 10\^5 plaque forming units \[pfu\], V590 2.4 x 10\^6 pfu, V590 1.15 x 10\^7 pfu, V590 5.55 x 10\^7 pfu or placebo) as specified in the protocol.

Conditions

• Coronavirus Disease (COVID-19)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-29
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2020-09-30
• Last updated: 2021-12-29
• Results posted: 2021-12-29

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study