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

General information
EudraCT Number: 2020-001286-36
CTA Load Date: 2020-06-05
Sponsor’s protocol code number: CV-NCOV-001
Start date recruitment: 2020-06-15
Start date recruitment (EU): 2020-06-15
Gender
Population Female: Yes
Population Male: Yes
Age group(s)
Children (2-11 years): No
Age Range > 18 yrs: No
Adults (18-64 years): Yes
Elderly (≥ 65 years): No
Type of trial subjects
Healthy Volunteers: Yes
Patients: No
Specific vulnerable populations: Yes
Trial type and phase
Randomised: Yes
Has the IMP been designated in this indication as an orphan drug: No
Amendment type: not available
Human Pharmacology (Phase I): Yes
Therapeutic Exploratory (Phase II): No
Therapeutic Confirmatory (Phase III): No
Therapeutic Use (Phase IV): No
Disease or condition under investigation
Medical condition(s) being investigated: Vaccination for prophylaxis of COVID-19 (healthy adults)
Medical condition in easily understood language: Prophylactic vaccine against COVID-19
MedDRA HLGT Code: 10043413
MedDRA HLGT Name: Therapeutic procedures and supportive care NEC
MedDRA HLT Code: 10021431
MedDRA HLT Name: Immunisations
MedDRA LLT Code: 10084464
MedDRA LLT Name: COVID-19 immunization
Condition being studied is a rare disease: No
Information on the site
National competent authority: Belgium - FPS Health-DGM
Institution name: University Hospital
Department name: Clinical Trial Unit CEVAC
Street: Corneel Heymanslaan 10
Town: Gent
Postal code: 9000
Country: Belgium
Phone number: (0)93323493
Principal inclusion and exclusion criteria
Principal inclusion criteria:

1. Healthy male and female subjects aged 18 to 60 years inclusive.
2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
3. Physical examination and laboratory results without clinically significant findings according to the Investigator’s assessment.
The full list of inclusion criteria is provided in the protocol.

Principal exclusion criteria:

Subjects will not be enrolled in this trial if they meet any of the exclusion criteria.
The following criterion applies to all open-label sentinel subjects:
1. Subjects with SARS-CoV-2 positive serology as confirmed by testing at enrollment.
The following criteria apply to all subjects, except those with SARS-CoV-2 positive serology:
2. Subjects considered at the Investigator's discretion to be at increased risk to acquire COVID-19 disease (including, but not limited to, health care workers with direct involvement in patient care or care of long-term care recipients).
3. History of confirmed COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
The following criteria apply to all subjects:
4. 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.
5. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
6. Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
The full list of exclusion criteria is provided in the protocol.