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Column | Value |
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Trial registration number | NCT05477186 |
Full text link
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
2022-07-28 |
Recruitment status
Last imported at : Sept. 23, 2023, midnight Source : ClinicalTrials.gov |
Completed |
Study design
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
nonRCT |
Allocation
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Non-randomized |
Design
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Sequential assignment |
Masking
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
Study aim
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: must provide documented informed consent prior to any study procedures being performed is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits has received at least 2 doses of comirnaty or moderna covid-19 vaccine (spikevax®), with the last dose of vaccine received at least 6 months prior to screening negative for sars-cov-2 infection by rt-pcr test at screening is a male or nonpregnant female ≥18 years old if the participant is a woman of child bearing potential, the participant agrees to use at least 1 highly effective form of contraception for at least 30 days prior to the study vaccination up to 3 months after study vaccination. agrees to refrain from blood or plasma donation from the first study vaccination through end of study. has a body mass index of 18 to 40 kg/m2, inclusive, at screening. is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings |
Exclusion criteria
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
participant is female and has a positive pregnancy test result at screening. participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination. has an acute febrile illness with temperature ≥38.0°c or ≥100.4°f within 72 hours before study vaccination. individuals with suspected covid-19 symptoms should be excluded and referred for medical care. has a history of documented sars-cov-2 infection or covid-19 within 6 months before screening. has a documented medical history of hiv, hepatitis b or hepatitis c infection prior to screening, or a positive test for these conditions at screening. any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy immunotherapy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of the first study vaccination. inclusion of persons who use low dose topical, ophthalmic, inhaled, or intranasal steroid preparations is permitted. history of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (eg, due to enterovirus or adenovirus), and celiac disease. has a new onset, clinically significant, abnormal biochemistry or hematology finding (defined as ≥grade 1) at screening (adults with grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study). individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, guillain- barré syndrome, multiple sclerosis, sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), takayasu arteritis, granulomatosis with polyangiitis, psoriasis, and insulin-dependent diabetes mellitus (type 1). has an unstable chronic medical condition. this refers to a condition requiring a new medication or increase in dose of current medication(s) or a condition requiring hospitalization within 6 months prior to screening. has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions, to vaccines or to any component of the investigational product. has received or plans to receive any licensed vaccine, within 4 weeks before or 4 weeks after study vaccination. inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination. has had known close contact with anyone who had a confirmed sars-cov-2 infection within 2 weeks before study vaccination. rescreening of these participants permitted after quarantine period is complete. has participated or plans to participate in another investigational study involving any investigational product or device within 6 months or 5 half-lives, whichever is longer, before the study vaccination through end of study. has received or plans to receive immunoglobulins or any blood or blood products within 3 months before the first study vaccination through end of study. has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination. has any abnormal skin condition or permanent body art (eg, tattoo) that would interfere with the ability to observe local reactions at the injection site. has a medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the individual at an unacceptable risk of injury, render the individual unable to meet the requirements of the protocol, or interfere with the individual's successful completion of the trial. participant is an employee or family member of the investigator or study site personnel. |
Number of arms
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
7 |
Funding
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
GlaxoSmithKline |
Inclusion age min
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Australia;Philippines;United States |
Type of patients
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
180 |
primary outcome
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study;Percentage of participants with each abnormal clinical safety laboratory finding for 8 days after study vaccination;Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study;Percentage of participants with serious adverse events (SAEs) from study vaccination through the end of the study;Percentage of participants with solicited local adverse events (AE) during 7 days after vaccination;Percentage of participants with solicited systemic AE during 7 days after vaccination;Percentage of participants with unsolicited AEs for 28 days after study vaccination |
Notes
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Phase 1 |
Arms
Last imported at : July 29, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Cohort 1 (12 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 2 (25 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 3 (50 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 4 (75 \u03bcg or 100 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 5 (100 \u03bcg, 150 \u03bcg or 200 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 6 (3 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Cohort 7 (6 \u03bcg)", "treatment_id": 2577, "treatment_name": "Cv0501", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |