NCT05870839

Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Healthy Adults in the United States

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Vaccine Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults.

Detailed description

This is a phase 1, multisite clinical trial to evaluate the safety and immunogenicity of 3 dose levels of VXCO-100 in healthy adult volunteers. Participants will be vaccinated with 1 dose of VXCO-100 on Day 1. A subset of participants will be offered an optional interim boost at month 3. Safety will be evaluated 1) before proceeding to a higher dose level and 2) prior to enrollment of participants aged 56 years and older at a particular dose level.

Conditions

• SARS-CoV
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	VXCO-100	Sterile liquid for injection

Timeline

• Start date: 2023-05-11
• Primary completion: 2024-04-10
• Completion: 2024-04-10
• First posted: 2023-05-23
• Last updated: 2024-12-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study