NCT04860258

COVID-19: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of the SARS-CoV-2 mRNA Vaccine CVnCoV in Adults With Co-morbidities

COVID-19: A Phase 3 Multicenter Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Above With Co-morbidities

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: CureVac · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine CVnCoV, and to evaluate the humoral immune responses 14 days after 2 dose administrations of CVnCoV.

Detailed description

Study participants with the following mild to moderate per protocol defined co-morbidities will be recruited: chronic kidney disease (CKD); cardiovascular disease (CVD), chronic obstructive pulmonary disease (COPD), type-2-diabetes. After safety data review, recruitment for severe cases will be opened. No severity classification will be done for study participants with chronic human immunodeficiency virus (HIV) infection with stable aviremia 12 months prior enrollment, for renal transplant patients if stable under medication for at least 6 months prior enrollment, and for study participants with a body mass index \> 32 kg/m\^2. 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

• Coronavirus
• Covid19
• SARS-CoV-2
• Severe Acute Respiratory Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	CVnCoV Vaccine	Intramuscular (IM) injection in the deltoid area, preferably in the non-dominant arm.

Timeline

• Start date: 2021-04-22
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2021-04-26
• Last updated: 2022-05-13
• Results posted: 2022-05-13

Locations

4 sites across 1 country: Belgium