NCT05938075

Study of VXCO-100, a SARS-CoV Candidate Vaccine, in Adults in the Republic of South Africa

Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of VXCO-100 in Adults in the Republic of South Africa

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (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 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 adults. Participants will be vaccinated with a selected dose of VXCO-100 or a COVID-19 mRNA vaccine. Participants will receive a dose of VXCO-100 on Day 1. A matched optional boost on month 6 will be offered to a subset of participants in Groups 1-3. Participants receiving a COVID-19 mRNA vaccine will be vaccinated on Day 1 and Day 21. Safety will be evaluated before proceeding to a higher dose level.

Conditions

• SARS-CoV
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	VXCO-100	Sterile suspension for injection
BIOLOGICAL	COVID-19 mRNA vaccine	Sterile suspension for injection

Timeline

• Start date: 2023-08-04
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2023-07-10
• Last updated: 2024-12-10

Locations

2 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study