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

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003998-22-DE

Enrollment

36500

Registered

2020-11-19

Start date

2020-12-11

Completion date

Unknown

Last updated

2022-01-10

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: 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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: 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. Primary Safety Objectives • To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older. • To evaluate the reactogenicity of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial. OBJECTIVES FOR THE OPEN-LABEL PHASE: Primary Safety Objective: • To evaluate safety in all subjects = 18 years of age remaining in the trial after unblinding;Secondary Objective: SECONDARY OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: Key Secondary Efficacy Objectives • 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. • 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 of first episodes of virologically-confirmed cases of COVID-19 of any severity caused by “wild type” (i.e., WT/D614G lineages A.1/B.1 without the variant of concern [VOC] B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and “UK” (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects. SECONDARY OBJECTIVES FOR THE OPEN-LABEL PHASE: None. For full list see protocol.;Primary end point(s): END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: Primary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} cases of COVID-19 of any severity meeting the case definition for the primary effic	—

Measure

Time frame

Main Objective: OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: 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. Primary Safety Objectives • To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older. • To evaluate the reactogenicity of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial. OBJECTIVES FOR THE OPEN-LABEL PHASE: Primary Safety Objective: • To evaluate safety in all subjects = 18 years of age remaining in the trial after unblinding;Secondary Objective: SECONDARY OBJECTIVES FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: Key Secondary Efficacy Objectives • 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. • 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 of first episodes of virologically-confirmed cases of COVID-19 of any severity caused by “wild type” (i.e., WT/D614G lineages A.1/B.1 without the variant of concern [VOC] B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and “UK” (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects. SECONDARY OBJECTIVES FOR THE OPEN-LABEL PHASE: None. For full list see protocol.;Primary end point(s): END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE: Primary Efficacy Endpoints • Occurrence of first episodes of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} cases of COVID-19 of any severity meeting the case definition for the primary effic

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Secondary

Measure	Time frame
Secondary end point(s): SECONDARY END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE ONLY: Key Secondary Efficacy Endpoints • 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 defined in Appendix 3 and Appendix 4). • 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 defined in Appendix 3). • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition due to infection with “wild type” (i.e., WT/D614G lineages A.1/B.1 without VOC B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and “UK” (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects. Secondary Immunogenicity Endpoints (Phase 2b Immunogenicity Subset): SARS-CoV-2 RBD of S protein antibody responses on Days 1, 29, 43, 120, and 211: • 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. SARS-CoV-2 viral neutralizing antibody responses on Days 1, 29, 43, 120, and 211: • Serum viral 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. Full list of secondary end points is provided in the protocol.;Timepoint(s) of evaluation of this end point: as specified in the endpoints	—

Measure

Time frame

Secondary end point(s): SECONDARY END POINTS FOR THE RANDOMIZED OBSERVE-BLINDED PHASE ONLY: Key Secondary Efficacy Endpoints • 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 defined in Appendix 3 and Appendix 4). • 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 defined in Appendix 3). • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition due to infection with “wild type” (i.e., WT/D614G lineages A.1/B.1 without VOC B.1.1.7 [Alpha], B.1.351 [Beta], B.1.429 [Epsilon]) and “UK” (B.1.1.7 [Alpha]) SARS CoV 2 strains in SARS CoV 2 naïve subjects. Secondary Immunogenicity Endpoints (Phase 2b Immunogenicity Subset): SARS-CoV-2 RBD of S protein antibody responses on Days 1, 29, 43, 120, and 211: • 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. SARS-CoV-2 viral neutralizing antibody responses on Days 1, 29, 43, 120, and 211: • Serum viral 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. Full list of secondary end points is provided in the protocol.;Timepoint(s) of evaluation of this end point: as specified in the endpoints

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Countries

Argentina, Belgium, Colombia, Dominican Republic, 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: Feb 4, 2026