Vaccination for prophylaxis of COVID-19 (healthy adults) MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 100000004865
Conditions
Interventions
Product Name: CVnCoV
Product Code: CV07050101
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Zorecimeran
Current Sponsor code: R9515
Other descriptive name: R9515
Concentration unit:
Sponsors
CureVac AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 18 years of age or older. 2. HCWs, employees or students in clinical training. 3. Provide written informed consent prior to initiation of any trial procedures. 4. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit. The full list of inclusion criteria is provided in the protocol. 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 2500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. History of virologically-confirmed SARS-CoV-2 infection or SARS-CoV-2 positive serology. 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 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. The full list of exclusion criteria is provided in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary Safety Endpoints • Occurrence, intensity and relationship of medically-attended AEs collected through 6 months after the second trial vaccination in all subjects. • Occurrence, intensity and relationship of SAEs and AESIs collected through 1 year after the second trial vaccination in all subjects. • Occurrence of fatal SAEs through 1 year after the second trial vaccination in all subjects. • Occurrence of AEs leading to vaccine withdrawal or trial discontinuation through 1 year after the second trial vaccination in all subjects. • Occurrence, intensity and duration of each solicited local AE within 7 days after each trial vaccination in a subset of subjects. • Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in a subset of subjects. • Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in a subset of subjects. Primary Immunogenicity Endpoint SARS-CoV-2 RBD of S protein antibody responses in a subset of subjects On Days 1, 29 and 43: • Serum antibodies to SARS-CoV-2 RBD of S protein. • Occurrence of seroconversion to SARS-CoV-2 RBD of S protein. - Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of subjects who tested seronegative at baseline.;Timepoint(s) of evaluation of this end point: as specified in the endpoints;Main Objective: Primary Safety Objective • To evaluate the safety (in all subjects) and reactogenicity (in a subset of subjects) of CVnCoV administered as a 2-dose schedule to adults 18 years of age or older. Primary Immunogenicity Objective • To assess antibody responses to the Receptor-binding domain (RBD) of S protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of subjects. ;Secondary Objective: • To assess the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-con | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed (RT-PCR) cases of COVID-19 of any severity meeting the case definition for the efficacy analysis. • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 meeting the case definition for the efficacy analysis by severity (mild, moderate, severe and moderate to severe COVID-19) as defined in Appendix 3 and Appendix 4. • BoD scores calculated based on first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the efficacy analysis. - BoD #1 – no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. - BoD #2 – no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3 Secondary Immunogenicity Endpoints SARS-CoV-2 virus neutralizing antibody responses in a subset of subjects On Days 1, 29 and 43: • Serum neutralizing antibodies to SARS-CoV-2 virus, as measured by a virus neutralizing assay. • Occurrence of seroconversion to SARS-CoV-2 virus, as measured by a virus neutralizing assay. - Seroconversion is defined as detectable SARS-CoV-2 Virus neutralizing antibodies in the serum of subjects who tested seronegative at baseline. Lot-to-lot consistency of 2 CVnCoV lots, as measured by SARS-CoV-2 RBD of S protein antibody responses in a subset of subjects On Day 43: • Serum antibodies to SARS-CoV-2 RBD of S protein.;Timepoint(s) of evaluation of this end point: as specified in the endpoints | — |
Countries
Germany
Contacts
Public ContactClinical Trial Information
CureVac AG
Outcome results
None listed