SARS-CoV-2 Corona virus Covid-19
Conditions
Interventions
2 doses of CvnCoV (12 µg dose) or saline placebo, 28 days apart, administered
via intermuscular injection
Sponsors
CureVac AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for all subjects: Subjects will be enrolled in this trial only if they meet all of the following criteria: 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. 6. 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; • Intrauterine hormone-releasing systems; • Bilateral tubal ligation; • Vasectomized or infertile partner; 7. Sexual abstinence {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation methods) and withdrawal are not acceptable}.
Exclusion criteria
Exclusion criteria: Subjects will not be enrolled in this trial if they meet any of the following 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 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. 6. Any treatment with immunosuppressants or other immune-modifying drugs (including but not limited to anabolic steroids, 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. 7. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination including known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); 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. 8. History of angioedema (hereditary or idiopathic) or history of any anaphylactic reaction. 9. History of pIMD. 10. History of allergy to any component of CVnCoV vaccine. 11. Administration of immunoglobulins or any blood products within 3 months prior to the administration of trial vaccine or planned receipt during the trial. 12. Subjects 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 subject unable to meet the requirements of the trial, or may interfere with the subject*s trial evaluations). These include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. However, those with controlled and stable cases can be included in the trial. 13. Subjects with impaired coagulation or any bleeding disorder in whom an IM injection or a blood draw is contraindicated. 14. Foreseeable non-compliance with the trial procedures as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint • 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. Primary Safety Endpoints All safety endpoints will be analyzed in all subjects, in subjects seronegative at baseline, and in subjects seropositive at baseline. • 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 throughout the trial in all subjects. • Occurrence of fatal SAEs throughout the trial in all subjects. • 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 discontinuation throughout the trial in all subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 is 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. . Other Secondary Efficacy Endpoints • In subjects >= 61 years of age, 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 virologically-confirmed (RT-PCR positive) SARS CoV 2 infection, with or without symptoms. If subject was symptomatic, onset of symptoms must have occurred >= 15 days following the second trial vaccination; if subject was asymptomatic, the positive RT-PCR test must have occurred >= 15 days following the second trial vaccination. • 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 primary efficacy analysis. o BoD #1 - no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. o BoD #2 - no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3. • Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 | — |
Countries
Netherlands
Outcome results
None listed