HERALD

Not Applicable

Recruiting

• Conditions: -B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-106-20
• Lead Sponsor: CureVac AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-29
• Study Completion: 2022-06-03
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 7448

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.
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 (IUDs);
· Intrauterine hormone-releasing systems (IUSs);
· Bilateral tubal occlusion;
· Vasectomized or infertile partner;
· Sexual abstinence {periodic abstinence (e.g., calendar, ovulation,
symptothermal and post-ovulation methods) and withdrawal are
not acceptable}.

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.
6. 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.
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 and pIMD.
9. History of allergy to any component of CVnCoV vaccine.
10. Administration of immunoglobulins or any blood products within
3 months prior to the administration of trial vaccine or planned receipt
during the trial.
11. 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.
12. Subjects with impaired coagulation or any bleeding disorder in whom
an intramuscular injection or a blood draw is contraindicated.
13. Foreseeable non-compliance with the trial procedures as judged by
the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified