COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05389319

University Hospital Tübingen

ITMPM@med.uni-tuebingen.de

2022-05-25

Recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

multi-center

Prevention

inclusion criteria: inclusion criteria healthy adult men or women aged 18 to 55 years full course of vaccination, including booster vaccination (i.e., having received 3 doses) with comirnaty, with the booster dose being administered at least 10 weeks before day 1 as documented in a respective vaccination certificate able to understand the participant information and providing written informed consent body mass index of 18.5 to 30.0 kg/m² and weight > 50 kg at screening women of childbearing potential must: have a negative pregnancy test at screening (blood) and at day 1 (urine) agree to use, and be able to comply with, highly effective measures of contraception without interruption, from 14 days before prime-2-cov_beta booster vaccination until the end of the study. a highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly) for this study: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence or vasectomized sexual partner. abstinence is only acceptable as true abstinence when this is in line with the preferred and usual lifestyle of the participant (abstinent on a long-term and persistent basis). the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal] are not acceptable methods of contraception.) postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy or bilateral oophorectomy) may be enrolled. male participants must agree not to intend to father a child or to donate sperm starting at screening, throughout the clinical study. male participants must also abstain from sexual intercourse with a female partner (acceptable only if it is the participant's usual form of birth control/lifestyle choice: abstinent on a long-term and persistent basis). the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant or use adequate barrier contraception (male condom) during treatment with the investigational product until the end of the study, and ensure that, if they have a female partner of childbearing potential, the partner uses a highly effective contraceptive method as outlined in inclusion criterion number 5 use condoms during the entire study if they have a pregnant partner, to avoid exposure of the fetus to the investigational product willing and able to comply with all study procedures based on the investigator's judgment

previous and concomitant therapy: receipt of any vaccine (licensed or investigational) from 4 weeks before prime-2-cov_beta booster vaccination or anticipated vaccination during the study until 6 weeks after the prime-2-cov_beta booster vaccination previous vaccination against covid-19 with vaccines (licensed or investigational) other than comirnaty current or previous treatment with another investigational drug and/or medical device (within 30 days of enrollment or 5 half-lives of that investigational drug) administration of immunoglobulins or any blood products within 2 months of prime-2-cov_beta booster vaccination chronic administration of medication associated with impaired immune responsiveness as judged by the investigator (including, but not limited to: immunosuppressive therapy, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy shots for hypo-sensitization, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs) within 2 months before the prime-2-cov_beta booster vaccination (day 1). inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. previous and concomitant medical condition: active sars-cov-2 infection, confirmed by a commercially available sars-cov-2 rapid antigen test at day 1, or currently on quarantine confirmed (by real-time quantitative polymerase chain reaction) sars-cov-2 infection after 2nd vaccination with comirnaty known history of severe adverse reactions to any vaccine and/or severe allergic reactions to any component of the study vaccine, to any drug, or to any other exposure known history of angioedema pregnant or lactating women any confirmed or suspected immunosuppressive or immunodeficient condition known history of guillain-barré syndrome known infection with human immunodeficiency virus, hepatitis c virus or hepatitis b virus active cancer (malignancy) within 5 years before day 1 (except for adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator) moderate or severe illness and/or fever > 38.0 °c within 1 week before prime-2-cov_beta booster vaccination any clinically significant health problem (medical history and physical examination) or clinically significantly abnormal finding in biochemistry and/or hematology blood tests, urinalysis, or electrocardiogram at screening according to the investigator's opinion current or history of cardiovascular disease or structural cardiac disease (including chronic or congenital heart conditions, such as chronic hypertension, coronary heart disease, myocardial infarction and arrhythmias, hypertrophic cardiomyopathy, as well as a history of myocarditis after mrna vaccinations) history of mrna vaccination-associated adverse events that were in nature and severity beyond the common aes expected current or history of gastrointestinal disease, liver disease, renal disease or endocrine disorders, (including diabetes) and neurological illness (excluding migraine), when judged as clinically significant according to the investigator's opinion current or history of chronic respiratory diseases, including mild asthma treated by on-demand medication (resolved childhood asthma is allowed) current or history of alcohol and/or drug abuse within the last 6 months before day 1 previous and concomitant clinical study experience current participation in another study or previous enrollment in this clinical study other exclusion criteria investigator or employee of the study group or sponsor with direct involvement in the proposed study or relatives of the research staff with direct involvement in the proposed study prolonged exposure to sheep or goats (e.g., shepherds, sheep farmer)

5

University Hospital Tuebingen

18

55

Germany

Healthy volunteers

N/A

60

Proportion of participants with solicited local adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): pain at injection site, redness, induration, and swelling.;Proportion of participants with solicited systemic adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): fever, fatigue, headache, chills, vomiting, nausea, diarrhea, new or worsened muscle pain, new or worsened joint pain.;Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study;Proportion of participants with unsolicited treatment-emergent adverse events throughout the study

None

Phase 1

[{"arm_notes": "30 000 PFUs", "treatment_id": 2483, "treatment_name": "Prime-2-cov_beta", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "300 000 PFUs", "treatment_id": 2483, "treatment_name": "Prime-2-cov_beta", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3 000 000 PFUs", "treatment_id": 2483, "treatment_name": "Prime-2-cov_beta", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "150 000 000 PFUs", "treatment_id": 2483, "treatment_name": "Prime-2-cov_beta", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 000 000 PFUs", "treatment_id": 2483, "treatment_name": "Prime-2-cov_beta", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]