Clinical trial NCT04674189: A Study to Evaluate the Safety and Immunogenicity of Vaccine CVnCoV in Healthy Adults in Germany for COVID-19
Official title: COVID-19: A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronavirus
Covid19
SARS-CoV-2
Severe Acute Respiratory Syndrome
Keywords: Vaccine
SARS
COVID
Safety
Immunogenicity
Lead sponsor: CureVac
Sponsor class: INDUSTRY
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2020-12-19
Enrollment: 2357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (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 participants.


Eligibility criteria: Inclusion Criteria:

* Male or female participants 18 years of age or older.
* Health care workers (HCWs), employees or students in clinical training.
* Provide written informed consent prior to initiation of any trial procedures.
* Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
* 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.
* Females of childbearing potential: negative urine pregnancy test (human chorionic gonadotropin within 24 hours prior to each trial vaccination on Day 1 and Day 29.
* Females of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:

  * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
  * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
  * Intrauterine devices (IUDs);
  * Intrauterine hormone-releasing systems (IUSs);
  * Bilateral tubal ligation;
  * Vasectomized partner;
  * Sexual abstinence (periodic abstinence \[e.g., calendar, ovulation, symptothermal and post-ovulation methods\] and withdrawal are not acceptable).

Exclusion Criteria:

* History of virologically confirmed SARS-CoV-2 infection or SARS-CoV-2 positive serology.
* For females: pregnancy or lactation.
* 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.
* Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) prior to the administration of trial vaccine.
* Prior administration of any investigational SARS-CoV-2 vaccine or other coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.
* Any treatment with immunosuppressants or other immune-modifying drugs (including but not limited to corticosteroids, biologicals and methotrexate) for \> 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted.
* Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), current diagnosis of or treatment for cancer including leukemia, lymphoma, Hodgkin disease, multiple myeloma or generalized malignancy; chronic renal failure or nephrotic syndrome; and receipt of an organ or bone marrow transplant.
* Active or chronic disease of, or currently on treatment for, hepatitis B virus (HBV) or hepatitis C virus (HCV).
* History of angioedema (hereditary or idiopathic), or a history of any anaphylactic reaction.
* History of Potential immune-mediated disease (pIMD).
* History of allergy to any component of CVnCoV vaccine.
* Administration of immunoglobulins or any blood products within 3 months prior to the administration of trial vaccine, or planned receipt during the trial.
* Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). These include severe and/or un-controlled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses.
* Participants with impaired coagulation or any bleeding disorder in whom an intramuscular (IM) injection or a blood draw is contraindicated. However, those with controlled and stable cases can be included in the trial.
* Foreseeable non-compliance with protocol as judged by the Investigator.

Primary outcomes:
measure: Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2
timeFrame: Up to 6 months after Dose 2 (Days 29 to 211)
measure: Number of Participants Who Experienced a Serious Adverse Event (SAE)
timeFrame: Day 1 to Day 393
measure: Intensity of SAEs Per the Investigator's Assessment
timeFrame: Day 1 to Day 393
measure: Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2
timeFrame: Up to 1 year after Dose 2 (Days 29 to 393)
measure: Number of Participants Who Experienced Death Due to SAE
timeFrame: Day 1 to Day 393
measure: Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2
timeFrame: Up to 1 year after Dose 2 (Days 29 to 393)
measure: Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2
timeFrame: Up to 1 year after Dose 2 (Days 29 to 393)
measure: Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
timeFrame: Day 1 to 28 days after Dose 2 (Day 57)
measure: Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose
timeFrame: Day 1 to 28 days after Dose 2 (Day 57)
measure: Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43
timeFrame: Baseline (Day 1), Day 29 and Day 43
measure: SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43
timeFrame: Day 1, Day 29 and Day 43
Secondary outcomes:
measure: Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43
timeFrame: Baseline (Day 1), Day 29 and Day 43
measure: SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43
timeFrame: Day 1, Day 29 and Day 43
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz Langenbeckstr. 1
Study officials:
References: