COVID-19: A PHASE 2A, PARTIALLY OBSERVER-BLIND, MULTICENTER, CONTROLLED, DOSE-CONFIRMATION CLINICAL TRIAL TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS >60 YEARS OF AGE AND 18 TO 60 YEARS OF AGE

Not Applicable

• Conditions: -B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-054-20
• Lead Sponsor: CureVac AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-20
• Study Completion: 2022-02-21
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 341

Inclusion Criteria

Subjects will be enrolled in this trial only if they meet all of the following criteria:
1. Healthy male and female subjects ≥18 years of age.
A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
3. Physical examination without clinically significant findings according to the Investigator’s assessment.
4. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2.
5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before).
Additional information, please see the study protocol

Exclusion Criteria

Subjects will not be enrolled in this trial if they meet any of the exclusion criteria.
1. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
2. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
3. Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
4. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
5. Use of hormonal therapy for gender reassignment.
6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection.
Additional information, please see the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified