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.
- Conditions
- SARS-CoV-2Corona virusCovid-1910047438
- Registration Number
- NL-OMON50925
- Lead Sponsor
- CureVac AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2400
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}.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method