Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

Phase 1

• Conditions: Vaccination for prophylaxis of COVID-19 (healthy adults); MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003998-22-DE
• Lead Sponsor: CureVac AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-19
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36500

Inclusion Criteria

INCLUSION CRITERIA FOR ALL SUBJECTS:
1. Male or female subjects 18 years of age or older.
2. Be willing and able to provide written informed consent prior to initiation of any trial procedures.
3. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
4. Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for = 12 consecutive months prior to screening (Day 1)} without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
5. Females of childbearing potential: negative pregnancy test {human chorionic gonadotropin (hCG)} within 24 hours prior to each trial vaccination on Day 1 and Day 29.

Full list of inclusion criteria is provided in the protocol.

ROLL-OVER CRITERIA FOR THE OPEN-LABEL PHASE:
1. Subjects must have received at least 1 dose of CVnCoV during the randomized observer blinded phase.
2. Subjects must provide additional written informed consent to be eligible for the open label phase.
• Cohort A: CVnCoV-AV
3. Subjects of the CVnCoV treatment arm who received or will receive any AV as standard of care through their national vaccination program.
• Cohort B: CVnCoV only
3. Subjects have not received any vaccination with any other investigational/authorized SARS CoV-2 vaccine or another coronavirus (SARS CoV, MERS-CoV) vaccine
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6500

Exclusion Criteria

EXCLUSION CRITERIA FOR ALL SUBJECTS:
1. History of virologically-confirmed COVID-19 illness.
2. For females: pregnancy or lactation.
3. Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of the first trial vaccine or planned use during the trial.
4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated or any other vaccines) prior to the administration of the first trial vaccine.
5. Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.

Full list of exclusion criteria is provided in the protocol.

ROLL-OVER CRITERIA FOR THE OPEN-LABEL PHASE:
1. Subjects must have received at least 1 dose of CVnCoV during the randomized observer blinded phase.
2. Subjects must provide additional written informed consent to be eligible for the open label phase.
• Cohort A: CVnCoV-AV
3. Subjects of the CVnCoV treatment arm who received or will receive any AV as standard of care through their national vaccination program.
• Cohort B: CVnCoV only
3. Subjects have not received any vaccination with any other investigational/authorized SARS CoV-2 vaccine or another coronavirus (SARS CoV, MERS-CoV) vaccine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified