NCT04449276

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: CureVac · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.

Detailed description

Funded by Coalition for Epidemic Preparedness Innovations (CEPI). This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

• Severe Acute Respiratory Syndrome
• Coronavirus
• SARS-CoV-2
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	CVnCoV Vaccine	Participants will receive an intramuscular injection by needle in the deltoid area.
DRUG	Placebo	Participants will receive an intramuscular injection by needle in the deltoid area.

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2020-06-26
• Last updated: 2023-01-30
• Results posted: 2023-01-30

Locations

4 sites across 2 countries: Belgium, Germany