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

COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older - HERALD

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003998-22-NL

Enrollment

36500

Registered

2020-11-27

Start date

2020-12-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: CVnCoV Product Code: CV07050101 Pharmaceutical Form: Solution for injection INN or Proposed INN: Zorecimeran Current Sponsor code: R9515 Concentration unit: g/l gram(s)/litre Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female subjects 18 years of age or older. 2. 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, 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 urine 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. 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: 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 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Co-Primary Efficacy Objectives •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve subjects. •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve subjects. Primary Safety Objective •To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older. ;Secondary Objective: Key Secondary Efficacy Objectives •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed severe cases of COVID-19 in SARS-CoV-2 naïve subjects. •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention or reduction of asymptomatic infection by SARS-CoV-2 in seronegative subjects, as measured by seroconversion to the nucleocapsid (N) protein of the virus. Secondary Immunogenicity Objectives •To assess antibody responses to the S protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in a subset of subjects participating in Phase 2b of the trial. Secondary Safety Objective •To evaluate the reactogenicity and tolerability of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial. Full list of secondary objectives is provided in the protocol. ;Primary end point(s): Co-Primary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis. • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of moderate to severe COVID-19 meeting the case definition for the primary efficacy analysis (moderate and severe COVID-19 disease). Primary Safety Endpoints • Occurrence, intensity and relationship	—

Measure

Time frame

Main Objective: Co-Primary Efficacy Objectives •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve subjects. •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve subjects. Primary Safety Objective •To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older. ;Secondary Objective: Key Secondary Efficacy Objectives •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed severe cases of COVID-19 in SARS-CoV-2 naïve subjects. •To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention or reduction of asymptomatic infection by SARS-CoV-2 in seronegative subjects, as measured by seroconversion to the nucleocapsid (N) protein of the virus. Secondary Immunogenicity Objectives •To assess antibody responses to the S protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in a subset of subjects participating in Phase 2b of the trial. Secondary Safety Objective •To evaluate the reactogenicity and tolerability of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial. Full list of secondary objectives is provided in the protocol. ;Primary end point(s): Co-Primary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis. • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of moderate to severe COVID-19 meeting the case definition for the primary efficacy analysis (moderate and severe COVID-19 disease). Primary Safety Endpoints • Occurrence, intensity and relationship

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Secondary

Measure	Time frame
Secondary end point(s): Key Secondary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) severe cases of COVID-19 meeting the case definition for the primary efficacy analysis (severe COVID-19 disease) • Occurrence of seroconversion to the N protein of SARS-CoV-2 = 15 days after the second trial vaccination in asymptomatic seronegative subjects. Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at Day 1 (baseline) and Day 43 (i.e. at the 2 testing time points prior to 15 days after the second trial vaccination). Secondary Immunogenicity Endpoints (Phase 2b Immunogenicity Subset) SARS-CoV-2 S protein antibody responses On Days 1, 29, 43, 57, 120, 211 and 393: • Serum antibodies to SARS-CoV-2 S protein. • Occurrence of seroconversion to SARS-CoV-2 S protein. Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of subjects who tested seronegative at baseline. SARS-CoV-2 viral neutralizing antibody responses On Days 1, 29, 43, 57, 120, 211, and 393: • Serum neutralizing antibodies to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay. • Occurrence of seroconversion to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay. Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of subjects who tested seronegative at baseline. Secondary Safety Endpoints • Occurrence, intensity and duration of each solicited local AE within 7 days after each trial vaccination in Phase 2b subjects. • Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in Phase 2b subjects. • Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in Phase 2b subjects. • Occurrence of AEs leading to vaccine withdrawal or trial discontinuatio	—

Measure

Time frame

Secondary end point(s): Key Secondary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) severe cases of COVID-19 meeting the case definition for the primary efficacy analysis (severe COVID-19 disease) • Occurrence of seroconversion to the N protein of SARS-CoV-2 = 15 days after the second trial vaccination in asymptomatic seronegative subjects. Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at Day 1 (baseline) and Day 43 (i.e. at the 2 testing time points prior to 15 days after the second trial vaccination). Secondary Immunogenicity Endpoints (Phase 2b Immunogenicity Subset) SARS-CoV-2 S protein antibody responses On Days 1, 29, 43, 57, 120, 211 and 393: • Serum antibodies to SARS-CoV-2 S protein. • Occurrence of seroconversion to SARS-CoV-2 S protein. Seroconversion is defined as detectable SARS-CoV-2 S protein antibodies in the serum of subjects who tested seronegative at baseline. SARS-CoV-2 viral neutralizing antibody responses On Days 1, 29, 43, 57, 120, 211, and 393: • Serum neutralizing antibodies to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay. • Occurrence of seroconversion to SARS-CoV-2 virus, as measured by a viral neutralizing antibody assay. Seroconversion is defined as detectable SARS-CoV-2 viral neutralizing antibodies in the serum of subjects who tested seronegative at baseline. Secondary Safety Endpoints • Occurrence, intensity and duration of each solicited local AE within 7 days after each trial vaccination in Phase 2b subjects. • Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in Phase 2b subjects. • Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in Phase 2b subjects. • Occurrence of AEs leading to vaccine withdrawal or trial discontinuatio

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Countries

Argentina, Belgium, Colombia, Dominican Republic, France, Germany, Mexico, Netherlands, Panama, Peru, Spain

Contacts

Public ContactClinical Trial Information

CureVac AG

clinicaltrials@curevac.com00496976805870

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Jul 23, 2026